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| Name | Class |
|---|---|
| CHI St. Luke's Health, Texas | OTHER |
| Aldagen | INDUSTRY |
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Recent studies have suggested that it may be possible to grow new blood vessels (angiogenesis) to supply the heart muscle that is currently not getting enough blood. One theory is that a certain type of stem cell, aldehyde dehydrogenase bright stem cells, may stimulate the growth of new vessels. After a bone marrow procedure, the special cells are separated and then injected back into the heart around the area of damage with a special guidance and injection system.
Once a patient meets all inclusion criteria and no exclusion criteria, he/she will be consented to the study and extensive baseline testing will be completed at St. Luke's Episcopal Hospital in Houston, Texas. Once all baseline criteria are met, the patient has his/her own bone marrow harvested and later injected, if randomized to receive active treatment. The day after the bone marrow harvest, the patient is taken to the cardiac catheterization lab where NOGA mapping is performed and the processed cells or placebo are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow-up at weeks 1 and 4, and months 3 and 6, and at one year unless there is a crossover and then he/she begins baseline again at 6 months and follow-up for one more year. Follow-up testing, including quality of life and NOGA mapping, is done at the time of injection, as well as at 6 months.
This is a phase I, double blind trial to evaluate the use of Aldehyde Dehydrogenase-Bright (ALDHbr) in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections of autologous bone marrow cells in patients with end-stage ischemic heart disease is safe, can provide neovascularization, and can improve perfusion and myocardial contractility. The primary object of this study is to assess the safety of the ALDHbr cell injections. The efficacy will be based upon treadmill MVO2. A maximum of 60 patients will be enrolled in the study. At the end of 6 months, after the required testing has been completed, the patients will be told whether they were in the control group or not. The patients in the control group will be given the option to crossover and actually receive stem cell injection. At the time of crossover, which then becomes the baseline, patients will begin the follow-up with all testing including clinic visits for one year for a total of 18 months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cell Therapy | Active Comparator | Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. |
|
| Control | Placebo Comparator | Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cell Therapy | Biological | Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events | Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death). | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| New York Heart Association (NYHA) Classification | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity. Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emerson Perin, MD, PhD | Texas Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Heart Institute/Baylor St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22424012 | Background | Perin EC, Silva GV, Zheng Y, Gahremanpour A, Canales J, Patel D, Fernandes MR, Keller LH, Quan X, Coulter SA, Moore WH, Herlihy JP, Willerson JT. Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase-bright stem cells in patients with ischemic heart failure. Am Heart J. 2012 Mar;163(3):415-21, 421.e1. doi: 10.1016/j.ahj.2011.11.020. Epub 2012 Feb 10. |
| Label | URL |
|---|---|
| The link is to Texas Heart Institute's Stem Cell Department home page. | View source |
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Relevant results are summarized and published. No need for individual results to be shared.
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Twenty one patients were recruited between 9/1/06 and 8/6/08 from outpatient Cardiology clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stem Cell Therapy | Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping. |
| FG001 | Control | Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stem Cell Therapy | Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events | Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death). | The data was analyzed for all participants in control and treated groups. | Posted | Number | participants | Baseline and 6 months |
|
Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stem Cell Therapy | Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| non-ST elevation MI/acute non-ST elevation MI | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| second degree AV block, type 2 | Cardiac disorders | Systematic Assessment |
The study is a preliminary study based on a small sample size which limits the statistical rigor of the analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emerson C. Perin, M.D., Ph.D. | Texas Heart Institute | 832-355-9405 | eperin@texasheart.org |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Control (plasma) | Other | Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml. |
|
| Baseline and 6 months |
| Canadian Cardiovascular (CCS) Angina Score | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain). Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation) | Baseline and 6 months |
| Echocardiography (EF)Percent (%) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction. | Baseline and 6 months |
| Left Ventricular End-Systolic Volume (LVESV) (ml) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV) when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters. | baseline and 6 months |
| Left Ventricular End-Diastolic Volume (LVEDV) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters. | baseline and 6 months |
| Echocardiography Wall Motion Score Index (WMSI) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI) as defined by the American Heart Association which allows detection of abnormalities in the heart wall or blood flowing through the heart. Using this model, the left ventricle is divided into 17 segments. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments. | baseline and 6 months |
| Myocardial Oxygen Consumption (MVO2) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute. | baseline and 6 months |
| Echocardiography (EF) Percent (%) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction. | baseline and 6 months |
| Total Severity Score (Stress) | For the stress test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling. Total severity score during stress is the sum of blackout pixels in the blackout polar map of myocardial perfusion during stress using cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean. Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion. | baseline and 6 months |
| Total Severity Score (Rest) | For the total severity score at rest, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest. Total severity score at rest is the sum of blackout pixels in the rest blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean. Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion. | baseline and 6 months |
| Total Severity Score (Reversible) | For the severity test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest/stress. Total severity score is the sum of blackout pixels in rest/stress blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by number of SDs below mean. Total severity score reversible is total severity scores at rest subtracted from those during stress. The severity score varies from 0 (normal) to > 1000 (poor perfusion) but upper limit is not well defined. | baseline and 6 months |
| Control |
Control (Placebo) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Stem Cell Therapy | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
|
|
| Secondary | New York Heart Association (NYHA) Classification | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity. Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound) | Posted | Mean | Standard Deviation | NYHA Functional class | Baseline and 6 months |
|
|
|
| Secondary | Canadian Cardiovascular (CCS) Angina Score | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain). Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
|
|
| Secondary | Echocardiography (EF)Percent (%) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction. | Posted | Mean | Standard Deviation | percentage of blood | Baseline and 6 months |
|
|
|
| Secondary | Left Ventricular End-Systolic Volume (LVESV) (ml) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV) when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters. | Posted | Mean | Standard Deviation | ml | baseline and 6 months |
|
|
|
| Secondary | Left Ventricular End-Diastolic Volume (LVEDV) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters. | Posted | Mean | Standard Deviation | ml | baseline and 6 months |
|
|
|
| Secondary | Echocardiography Wall Motion Score Index (WMSI) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI) as defined by the American Heart Association which allows detection of abnormalities in the heart wall or blood flowing through the heart. Using this model, the left ventricle is divided into 17 segments. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months |
|
|
|
| Secondary | Myocardial Oxygen Consumption (MVO2) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute. | data from 9 stem cell patients at 6 months, 10 at baseline | Posted | Mean | Standard Deviation | ml/kg/min | baseline and 6 months |
|
|
|
| Secondary | Echocardiography (EF) Percent (%) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction. | Posted | Mean | Standard Deviation | percentage of blood | baseline and 6 months |
|
|
|
| Secondary | Total Severity Score (Stress) | For the stress test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling. Total severity score during stress is the sum of blackout pixels in the blackout polar map of myocardial perfusion during stress using cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean. Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months |
|
|
|
| Secondary | Total Severity Score (Rest) | For the total severity score at rest, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest. Total severity score at rest is the sum of blackout pixels in the rest blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean. Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months |
|
|
|
| Secondary | Total Severity Score (Reversible) | For the severity test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest/stress. Total severity score is the sum of blackout pixels in rest/stress blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by number of SDs below mean. Total severity score reversible is total severity scores at rest subtracted from those during stress. The severity score varies from 0 (normal) to > 1000 (poor perfusion) but upper limit is not well defined. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 months |
|
|
|
| 10 |
| 10 |
| 10 |
| 10 |
| EG001 | Control | Placebo (control) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml. | 10 | 10 | 10 | 10 |
| ventricular tachycardia /ventricular tachycardia (ICD shocks)/ ventricular arrhythmia | Cardiac disorders | Systematic Assessment |
|
| new stenotic lesion in SVG to RCA | Cardiac disorders | Systematic Assessment |
|
| acute congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| inappropriate AICD function | Cardiac disorders | Systematic Assessment |
|
| bilateral eye cataracts | Eye disorders | Systematic Assessment |
|
| left eye macular edema | Eye disorders | Systematic Assessment |
|
| lightheadness or dizziness | General disorders | Non-systematic Assessment |
|
| cholelithiasis | Gastrointestinal disorders | Systematic Assessment |
|
| postoperative hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fentanyl overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| mild bleeding at right groin cath site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| intracerebral hemorrhage/ ischemic stroke/ embolic stroke | Nervous system disorders | Systematic Assessment |
|
| increased shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| community acquired pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| increased claudication | Vascular disorders | Non-systematic Assessment |
|
| dehydration | General disorders | Systematic Assessment |
|
| fever of unknown origin | General disorders | Systematic Assessment |
|
| hospitalization for sinusitis | Infections and infestations | Systematic Assessment |
|
| hypotension | Cardiac disorders | Systematic Assessment |
|
| ideoventricular rhythm | Cardiac disorders | Systematic Assessment |
|
| ischemic cardiomyopathy | Cardiac disorders | Systematic Assessment |
|
| acute bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| acute renal failure | Renal and urinary disorders | Systematic Assessment |
|
| altered mental status | Psychiatric disorders | Systematic Assessment |
|
| decreased platelet count | Blood and lymphatic system disorders | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| irregular heart rhythm | Cardiac disorders | Non-systematic Assessment |
|
| left ventricular thrombus | Cardiac disorders | Systematic Assessment |
|
| hypotension | Cardiac disorders | Systematic Assessment |
|
| increased troponin level | Cardiac disorders | Systematic Assessment |
|
| increased cardiac chest pain | Cardiac disorders | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| exacerbation of congestive heart failure | Cardiac disorders | Non-systematic Assessment |
|
| heart racing | Cardiac disorders | Non-systematic Assessment |
|
| hypertension elevation | Cardiac disorders | Systematic Assessment |
|
| new onset of atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| increased CPK | Cardiac disorders | Systematic Assessment |
|
| chest pain- nonspecific | Cardiac disorders | Non-systematic Assessment |
|
| possible apical thrombus | Cardiac disorders | Non-systematic Assessment |
|
| episode of atypical cardiac chest pain | Cardiac disorders | Non-systematic Assessment |
|
| left ventricular apical thrombus | Cardiac disorders | Non-systematic Assessment |
|
| sustained ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| diaphoresis | Cardiac disorders | Non-systematic Assessment |
|
| short periods of atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| labyrinthitis | Ear and labyrinth disorders | Non-systematic Assessment |
|
| increased hearing loss | Ear and labyrinth disorders | Non-systematic Assessment |
|
| elevated blood glucose | Endocrine disorders | Systematic Assessment |
|
| low testosterone level | Endocrine disorders | Systematic Assessment |
|
| photophobia | Eye disorders | Non-systematic Assessment |
|
| stomach flu | Gastrointestinal disorders | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| rectal polyp | Gastrointestinal disorders | Non-systematic Assessment |
|
| worsening constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| epigastric pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| cold symptoms | General disorders | Non-systematic Assessment |
|
| nasal discharge | General disorders | Non-systematic Assessment |
|
| productive cough | General disorders | Non-systematic Assessment |
|
| fever | General disorders | Systematic Assessment |
|
| obstructive sleep apnea | General disorders | Non-systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
|
| TIA symptoms | General disorders | Non-systematic Assessment |
|
| cough | General disorders | Non-systematic Assessment |
|
| drowsiness | General disorders | Non-systematic Assessment |
|
| nausea | General disorders | Non-systematic Assessment |
|
| syncope | General disorders | Non-systematic Assessment |
|
| weight loss | General disorders | Non-systematic Assessment |
|
| bleeding from bone marrow site | General disorders | Non-systematic Assessment |
|
| vertigo | General disorders | Non-systematic Assessment |
|
| intermittent right frontal headache | General disorders | Non-systematic Assessment |
|
| dehydration | General disorders | Non-systematic Assessment |
|
| dizziness, lightheadedness | General disorders | Non-systematic Assessment |
|
| weight gain | General disorders | Non-systematic Assessment |
|
| abnormal sleep pattern | General disorders | Non-systematic Assessment |
|
| nasal congestion | General disorders | Non-systematic Assessment |
|
| athlete's foot | General disorders | Non-systematic Assessment |
|
| lower extremity edema | General disorders | Non-systematic Assessment |
|
| bodyache | General disorders | Non-systematic Assessment |
|
| chills | General disorders | Non-systematic Assessment |
|
| poison oak exposure | General disorders | Non-systematic Assessment |
|
| rash | General disorders | Non-systematic Assessment |
|
| Bells Palsey | General disorders | Non-systematic Assessment |
|
| rash to neck and upper chest | General disorders | Non-systematic Assessment |
|
| rash from Holter | General disorders | Non-systematic Assessment |
|
| nose bleed | General disorders | Non-systematic Assessment |
|
| tooth decay | General disorders | Non-systematic Assessment |
|
| difficulty maintaining sleep | General disorders | Non-systematic Assessment |
|
| forgetfullness | General disorders | Non-systematic Assessment |
|
| mild headache after 6 min walk | General disorders | Non-systematic Assessment |
|
| bruised forehead due to fall | General disorders | Non-systematic Assessment |
|
| minor burns (from Halter electrodes) | General disorders | Non-systematic Assessment |
|
| flu-like syndrome | General disorders | Non-systematic Assessment |
|
| cold feet | General disorders | Non-systematic Assessment |
|
| facial numbness | General disorders | Non-systematic Assessment |
|
| numbness in extremity | General disorders | Non-systematic Assessment |
|
| increased liver function tests | Hepatobiliary disorders | Non-systematic Assessment |
|
| leukocytosis | Immune system disorders | Non-systematic Assessment |
|
| sinus infection | Infections and infestations | Non-systematic Assessment |
|
| strep throat | Infections and infestations | Non-systematic Assessment |
|
| viral syndrome | Infections and infestations | Non-systematic Assessment |
|
| Herpes Simplex | Infections and infestations | Non-systematic Assessment |
|
| influenza | Infections and infestations | Non-systematic Assessment |
|
| tooth infection | Infections and infestations | Non-systematic Assessment |
|
| infection of right index finger | Infections and infestations | Non-systematic Assessment |
|
| pain at bone marrow harvest site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| hypoglycemic | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| fluctuating glucose | Metabolism and nutrition disorders | Systematic Assessment |
|
| hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| symptomatic volume depletion | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| cervial neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bilateral knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pain in left arm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| left leg cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| left chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bone spurs in neck and spine | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| chipped bone fragment in neck | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bulging disk at lower back | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| injured miniscus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bilateral thigh pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| soreness in feet | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| left foot fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| sore left arm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| sore left knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| back tightness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| increase of chronic back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bilateral hyperreflexia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| increased forgetfulness | Psychiatric disorders | Non-systematic Assessment |
|
| psychological stress | Psychiatric disorders | Non-systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| elevated blood urea nitrogen (BUN) | Renal and urinary disorders | Non-systematic Assessment |
|
| elevated creatinine level | Renal and urinary disorders | Non-systematic Assessment |
|
| exacerbation of preexisting disease- kidney stones | Renal and urinary disorders | Non-systematic Assessment |
|
| renal insufficiency | Renal and urinary disorders | Non-systematic Assessment |
|
| large right renal cyst | Renal and urinary disorders | Non-systematic Assessment |
|
| atrophic vaginitis | Reproductive system and breast disorders | Non-systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| increased shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| non-productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| chest congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| emphysema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| plantar fascitis | Vascular disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |