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| Name | Class |
|---|---|
| CHI St. Luke's Health, Texas | OTHER |
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This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular Ejection Fraction (LVEF) of less than or equal to 45%. Once the patient meets all inclusion criteria, and no exclusion criteria are found, the subject is consented for the study, and extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline testing criteria is met, the patient has their own bone marrow harvested and later that day the subject is taken to a cardiac catheterization lab where left ventricular electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed stem cells 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 visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4, 5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits, including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell injection.
This is a phase 1, single-blind trial to evaluate the use of autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections of autologous mononuclear bone marrow cells in patients with end-stage ischemic heart disease is safe, can promote neovascularization, and can improve perfusion and myocardial contractility. The primary object of this study will be to evaluate the safety of autologous-bone-marrow mononuclear cell injections. The secondary endpoint of the study is to assess the efficacy of autologous bone marrow cells in improving cardiac contractile function and functional outcome. The efficacy will be assessed on the basis of the treadmill Max VO2 (maximum volume oxygen uptake). Secondarily the efficacy will be assessed on the basis of clinical status and imaging rests, with follow-up extending to 1 year after enrollment.A maximum of 30 patients will be enrolled in the study. At the end of the 6-month visit. after the required angiogram with mapping and non-invasive testing is complete, the patients will be told whether they were in the control or the active group (stem cell therapy). Those in the control group will be told before final invasive testing, and those who consent may cross over to the active therapy arm and undergo the cell injection procedure (control, then stem cell therapy. In these patients, the foll-up angiogram and mapping procedure will also serve as the baseline procedure required for cell injection. Bone marrow mononuclear cells will be injected in an identical fashion, according to the same criteria described for the original treatment group, and these patients will have identical follow-up visits starting again at the baseline time-point and extending for up to 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cell Therapy | Experimental | Subject is randomized to receive Stem Cell Therapy (intramyocardial injection of stem cells) via NOGA mapping. |
|
| Control, then Stem Cell Therapy | Other | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramyocardial Injection of stem cells via NOGA Mapping | Device | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping to deliver cells in the active arm of the protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Autologous-bone-marrow Injections | Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) 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). | up to 2 weeks post-procedure, 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emerson Perin, MD,PhD. | Texas Heart Institute/Baylor St Luke's Medical Center | 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 |
|---|---|---|---|
| 21641354 | Result | Perin EC, Silva GV, Henry TD, Cabreira-Hansen MG, Moore WH, Coulter SA, Herlihy JP, Fernandes MR, Cheong BY, Flamm SD, Traverse JH, Zheng Y, Smith D, Shaw S, Westbrook L, Olson R, Patel D, Gahremanpour A, Canales J, Vaughn WK, Willerson JT. A randomized study of transendocardial injection of autologous bone marrow mononuclear cells and cell function analysis in ischemic heart failure (FOCUS-HF). Am Heart J. 2011 Jun;161(6):1078-87.e3. doi: 10.1016/j.ahj.2011.01.028. Epub 2011 May 10. |
| Label | URL |
|---|---|
| Stem Cell Group at Texas Heart Institute | View source |
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Data summarized and published. No need to share individual patient data.
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Thirty patients were recruited between 4/14/04 and 2/8/07 from outpatient cardiology clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control, Then Stem Cell Therapy | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. |
| FG001 | Stem Cell Therapy | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control, Then Stem Cell Therapy | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. |
| BG001 | Stem Cell Therapy |
| 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 Autologous-bone-marrow Injections | Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) 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). | Adverse events which occurred in all participants. | Posted | Number | participants | up to 2 weeks post-procedure, 3 months and 6 months |
|
Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year 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 | Control, Then Stem Cell Therapy | Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment. At 6 months, subject is offered stem cell therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain and slightly elevated Troponin I | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ICD firing | General disorders | Non-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 |
|---|---|
| D003434 | Crossing Over, Genetic |
| ID | Term |
|---|---|
| D059765 | Homologous Recombination |
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
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|
| Control, then Stem Cell Therapy | Other | Subject is randomized to receive a NOGA mapping and no injections (sham treatment)at time of active enrollment and treatment then offered stem cell therapy at 6 months. |
|
|
| baseline, 3 months and 6 months |
| 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) | baseline, 3 months 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, 3 months 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, 3 months and 6 months |
| Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25. | baseline and 3 months |
| Echocardiography Wall Motion Score Index (WMSI) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. 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 3 months |
| Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction. | baseline, 3 months and 6 months |
| Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the "gold" standard. | 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, 3 months 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, 3 months and 6 months |
| Endocardial Unipolar Voltages (UPV) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is <5.5 mV. | baseline and 6 months |
| Linear Local Shortening (LLS) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction. | baseline and 6 months |
Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
| 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 |
|
| Stem Cell Therapy |
Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. |
|
|
| 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) | The data was analyzed for all participants in control and treated groups. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 months and 6 months |
|
|
|
| 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) | The data was analyzed for all participants in control and treated groups. | Posted | Mean | Standard Deviation | NYHA Functional Class | baseline, 3 months 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. | The data was analyzed for all participants in control and treated groups. | Posted | Mean | Standard Deviation | Percentage of Oxygen Saturation | baseline, 3 months 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. | The data was analyzed for all participants in control and treated groups. | Posted | Mean | Standard Deviation | Ejection Fraction % | baseline, 3 months and 6 months |
|
|
|
| Secondary | Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25. | The data was analyzed for all participants in control and treated groups. | Posted | Mean | Standard Deviation | VE/VCO2 slope | baseline and 3 months |
|
|
|
| Secondary | Echocardiography Wall Motion Score Index (WMSI) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. 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. | The data was analyzed for all participants in control and treated groups. | Posted | Mean | Standard Deviation | Wall Motion Score Index | baseline and 3 months |
|
|
|
| Secondary | Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction. | The data was analyzed for all participants in control and treated groups. | Posted | Mean | Standard Deviation | Left Ventricular Ejection Fraction (%) | baseline, 3 months and 6 months |
|
|
|
| Secondary | Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the "gold" standard. | The data was analyzed for all participants in control and treated groups. | Posted | Mean | Standard Deviation | Angiography LVEF (%) | 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 | Volume in left ventricle (milliliters) | baseline, 3 months 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. | The data was analyzed for all participants in control and treated groups. | Posted | Mean | Standard Deviation | ml | baseline, 3 months and 6 months |
|
|
|
| Secondary | Endocardial Unipolar Voltages (UPV) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is <5.5 mV. | The data was analyzed for all participants in control and treated groups. | Posted | Mean | Standard Deviation | Unipolar voltage (mV) | baseline and 6 months |
|
|
|
| Secondary | Linear Local Shortening (LLS) | Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction. | Posted | Mean | Standard Deviation | percentage of linear local shortening | baseline and 6 months |
|
|
|
| 7 |
| 10 |
| 9 |
| 10 |
| EG001 | Stem Cell Therapy | Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. | 11 | 20 | 18 | 20 |
| Confusion/disorientation | Nervous system disorders | Non-systematic Assessment |
|
| Elevated troponin,chestpain and fever with episode of cellulitis | Cardiac disorders | Non-systematic Assessment |
|
| False positive culture on processed stem cells at day 5 | Infections and infestations | Non-systematic Assessment |
|
| Hospitalized for chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalized for heart failure at one year | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Placement of AICD | Cardiac disorders | Non-systematic Assessment |
|
| Pulmonary edema & slightly elevated Troponin I with ablation of atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Pulmonary edema within 24 hrs of treatment | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Replacement of AICD | Cardiac disorders | Non-systematic Assessment |
|
| Restenosis without symptoms at 6 months, received stent | Cardiac disorders | Non-systematic Assessment |
|
| Staph aureus septicemia (left sternoclavicular area) leg | Infections and infestations | Non-systematic Assessment |
|
| Troponin I elevation in presence of new onset Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Urosepsis | Renal and urinary disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bronchitis, decompensated heart failure | Cardiac disorders | Non-systematic Assessment |
|
| decompensated heart failure | Cardiac disorders | Non-systematic Assessment |
|
| elevated Troponin T in presence of bacteremia | Cardiac disorders | Non-systematic Assessment |
|
| supraventricular tachycardia ablation | Cardiac disorders | Non-systematic Assessment |
|
| unstable angina and stent | Cardiac disorders | Non-systematic Assessment |
|
| urosepsis and chest pain | Cardiac disorders | Non-systematic Assessment |
|
| ventricular tachycardia during 6 month F/Ucath requiring cardioversion | Cardiac disorders | Non-systematic Assessment |
|
| abcess left sternovascular joint | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| abcess tooth | Infections and infestations | Non-systematic Assessment |
|
| abdominal bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| abnormalities/ pain eye | Eye disorders | Non-systematic Assessment |
|
| abnormality on MRI scan | General disorders | Non-systematic Assessment |
|
| albumin, increase | General disorders | Non-systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| back/ hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bloody nose | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| blurred vision | Eye disorders | Non-systematic Assessment |
|
| bone fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bone pain, extremities | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| carbuncles on body | Infections and infestations | Non-systematic Assessment |
|
| carpel tunnel release | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| cellulitis | Infections and infestations | Non-systematic Assessment |
|
| changes in cardiac enzymes (CK-MB,BNP,CRP, troponin) | Cardiac disorders | Non-systematic Assessment |
|
| changes in heart rate | Cardiac disorders | Non-systematic Assessment |
|
| changes in renal enzymes (BUN, creatinine, chloride) | Renal and urinary disorders | Non-systematic Assessment |
|
| chest pain/ increased chest pain | Cardiac disorders | Non-systematic Assessment |
|
| chills | Infections and infestations | Non-systematic Assessment |
|
| chronic obtructive pulmonary disease, increased symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cold/ congestion | General disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| crackles/ wheezes in lungs | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cramping | Gastrointestinal disorders | Non-systematic Assessment |
|
| decrease in platelets/ hematocrit | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| depression | Psychiatric disorders | Non-systematic Assessment |
|
| diabetes uncontrolled | Endocrine disorders | Non-systematic Assessment |
|
| diaphoresis | General disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| digestive problems | Gastrointestinal disorders | Non-systematic Assessment |
|
| disorientation | General disorders | Non-systematic Assessment |
|
| dizziness/ light-headedness | General disorders | Non-systematic Assessment |
|
| edema, extremity not specified | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| edema, upper extremities | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| electrocardiogram changes | Cardiac disorders | Non-systematic Assessment |
|
| eyes sensitive to light | Eye disorders | Non-systematic Assessment |
|
| fall/ balance problems | General disorders | Non-systematic Assessment |
|
| fatigue/ weakness | General disorders | Non-systematic Assessment |
|
| fever | General disorders | Non-systematic Assessment |
|
| gastroespohageal reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| gout, increased symptoms | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| gum bleeding | General disorders | Non-systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
|
| heart failure | Cardiac disorders | Non-systematic Assessment |
|
| heart palpitations | Cardiac disorders | Non-systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| hematoma at catheter site | General disorders | Non-systematic Assessment |
|
| hyperglycermia | Endocrine disorders | Non-systematic Assessment |
|
| hypertension | Cardiac disorders | Non-systematic Assessment |
|
| hypoglycemia | Endocrine disorders | Non-systematic Assessment |
|
| hypotension | Cardiac disorders | Non-systematic Assessment |
|
| influenza/ flu-like symptoms | Infections and infestations | Non-systematic Assessment |
|
| insomnia/ sleep disorders | General disorders | Non-systematic Assessment |
|
| itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| lesion right foot | Infections and infestations | Non-systematic Assessment |
|
| muscle pain/pull | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| myocardial infaction, non-ST elevation | Cardiac disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| numbness/ tingling in extremities | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| petechia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| pleuritic chest pain | Cardiac disorders | Non-systematic Assessment |
|
| probable obstructive sleep apnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| renal insufficiency/ urinary problems | Renal and urinary disorders | Non-systematic Assessment |
|
| sciatica | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| scrotal edema/ erythema | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| shingles | Infections and infestations | Non-systematic Assessment |
|
| shortness of breath, lying down | Cardiac disorders | Non-systematic Assessment |
|
| shortness of breath/ increased shortness of breath/ difficulty breathing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| sinus congestion/ compliant | General disorders | Non-systematic Assessment |
|
| skin flushing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| slurred speech/ dysphasia | Nervous system disorders | Non-systematic Assessment |
|
| soreness/ brusing | General disorders | Non-systematic Assessment |
|
| spider bite | General disorders | Non-systematic Assessment |
|
| swelling/ edema lower extremities | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| swelling/ edema upper extremity | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| tremors | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| upper respiratory infection | Infections and infestations | Non-systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| urinary/ bladder problems | Renal and urinary disorders | Non-systematic Assessment |
|
| virus | Infections and infestations | Non-systematic Assessment |
|
| weight gain | General disorders | Non-systematic Assessment |
|
| white blood count, elevated | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
| CCS 6 months |
|
| NYHA 6 months |
|
| MVO2 (ml/kg per min) 6 months |
|
| Echocardiography EF (%) 6 months |
|
| SPECT LVEF (%) 6 months |
|
| LVEDV (ml) 6 months |
|
| LVESV (ml) 6 months |
|