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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HL097131-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain.
Despite spending $12 billion annually on the emergency evaluation of chest pain in the US, only 15% of admitted patients have a cardiac cause of their presenting symptoms. Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The superior accuracy of CMR could decrease testing and invasive procedures. The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers. As a result, CMR could improve the care of emergency department (ED) patients with intermediate risk chest pain. However, the efficiency and safety of CMR has not been extensively tested in the CDU setting.
Primary Hypothesis: A CDU-CMR strategy will reduce the occurrence of the composite of revascularization, re-hospitalization, and recurrent cardiac testing at 90 days when compared to an inpatient care strategy.
Methods: Participants (n=146) at intermediate risk for acute coronary syndrome (ACS) will be recruited into a clinical trial from Wake Forest University Baptist Medical Center (WFUBMC) ED. Participants will be equally randomized to CDU-CMR or inpatient care. CDU-CMR participants will undergo resting and stress CMR imaging in parallel with serial cardiac markers. Inpatient care participants will undergo serial cardiac markers followed by existing cardiac testing as determined by their care providers. The primary outcome is the composite of 90 day revascularization, re-hospitalization, and recurrent cardiac testing. The secondary outcome is index hospitalization length of stay. Safety events include ACS after discharge, mortality, and stress testing-related adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inpatient Care | No Intervention | This is the comparison arm. Patients are admitted to the hospital and undergo usual care. | |
| CDU-CMR Protocol | Experimental | Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical decision unit care, coupled with cardiac MRI | Other | After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. |
| Measure | Description | Time Frame |
|---|---|---|
| The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. | Index Hospitalization through 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Duration of Index Hospitalization, an average of 1-2 days | |
| Acute Coronary Syndrome | Index Hospitalization discharge through 90 days | |
| Mortality |
Not provided
Inclusion Criteria:
Pretest probability assessment The assessment of intermediate risk for developing ACS will be based on a TIMI risk score >/= 2 and / or a board certified / board eligible emergency physician clinical impression of intermediate or high likelihood that the symptoms represent ACS. Physicians are encouraged to use the 2007 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines as a framework for this assessment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chadwick Miller, M.D. | WFUBMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17194875 | Background | Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available. | |
| 16841785 |
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No participants were excluded from the trial prior to treatment assignment.
Recruitment occurred in the Emergency Department (ED) at Wake Forest Baptist Medical Center from March 2010 to June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | CDU-CMR Protocol | Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. |
| FG001 | Inpatient Care | This is the comparison arm. Patients are admitted to the hospital and undergo usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CDU-CMR Protocol | Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. |
| 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 | The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. | Data from all participants was used in the primary outcome analysis. | Posted | Number | participants | Index Hospitalization through 90 days |
|
1 Year
Participants may have experienced more than one of the same type of adverse event. Participants may be counted more than once in each adverse event group or classification.
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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 | CDU-CMR Protocol | Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation. Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission for chest pain. | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ED visit for abdominal pain, constipation, and chest pain. | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Harper | Wake Forest Baptist Medical Center | 336-716-2059 | erharper@wakehealth.edu |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002637 | Chest Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005191 | Family Characteristics |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D015991 | Epidemiologic Measurements |
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|
| Index Hospitalization through 90 days |
| Stress Testing-related Adverse Event | Index Hospitalization through 90 days |
| Background |
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| 15100202 | Background | Puskas JD, Williams WH, Mahoney EM, Huber PR, Block PC, Duke PG, Staples JR, Glas KE, Marshall JJ, Leimbach ME, McCall SA, Petersen RJ, Bailey DE, Weintraub WS, Guyton RA. Off-pump vs conventional coronary artery bypass grafting: early and 1-year graft patency, cost, and quality-of-life outcomes: a randomized trial. JAMA. 2004 Apr 21;291(15):1841-9. doi: 10.1001/jama.291.15.1841. |
| 497341 | Background | O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56. |
| Background | Therneau TM, Grambsch PM, Fleming TR. Martingale-based residuals for survival models 10.1093/biomet/77.1.147. Biometrika 1990;77(1):147-60. |
| 10973764 | Background | Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. doi: 10.1053/euhj.2000.2305. |
| 10938172 | Background | Antman EM, Cohen M, Bernink PJ, McCabe CH, Horacek T, Papuchis G, Mautner B, Corbalan R, Radley D, Braunwald E. The TIMI risk score for unstable angina/non-ST elevation MI: A method for prognostication and therapeutic decision making. JAMA. 2000 Aug 16;284(7):835-42. doi: 10.1001/jama.284.7.835. |
| 10577561 | Background | Mahaffey KW, Puma JA, Barbagelata NA, DiCarli MF, Leesar MA, Browne KF, Eisenberg PR, Bolli R, Casas AC, Molina-Viamonte V, Orlandi C, Blevins R, Gibbons RJ, Califf RM, Granger CB. Adenosine as an adjunct to thrombolytic therapy for acute myocardial infarction: results of a multicenter, randomized, placebo-controlled trial: the Acute Myocardial Infarction STudy of ADenosine (AMISTAD) trial. J Am Coll Cardiol. 1999 Nov 15;34(6):1711-20. doi: 10.1016/s0735-1097(99)00418-0. |
| 15936605 | Background | Ross AM, Gibbons RJ, Stone GW, Kloner RA, Alexander RW; AMISTAD-II Investigators. A randomized, double-blinded, placebo-controlled multicenter trial of adenosine as an adjunct to reperfusion in the treatment of acute myocardial infarction (AMISTAD-II). J Am Coll Cardiol. 2005 Jun 7;45(11):1775-80. doi: 10.1016/j.jacc.2005.02.061. |
| 15589011 | Background | Karha J, Gibson CM, Murphy SA, Dibattiste PM, Cannon CP; TIMI Study Group. Safety of stress testing during the evolution of unstable angina pectoris or non-ST-elevation myocardial infarction. Am J Cardiol. 2004 Dec 15;94(12):1537-9. doi: 10.1016/j.amjcard.2004.08.033. |
| 23664718 | Derived | Miller CD, Case LD, Little WC, Mahler SA, Burke GL, Harper EN, Lefebvre C, Hiestand B, Hoekstra JW, Hamilton CA, Hundley WG. Stress CMR reduces revascularization, hospital readmission, and recurrent cardiac testing in intermediate-risk patients with acute chest pain. JACC Cardiovasc Imaging. 2013 Jul;6(7):785-94. doi: 10.1016/j.jcmg.2012.11.022. Epub 2013 May 8. |
| BG001 | Inpatient Care | This is the comparison arm. Patients are admitted to the hospital and undergo usual care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
This is the comparison arm. Patients are admitted to the hospital and undergo usual care. |
|
|
| Secondary | Length of Stay | Data from all participants was used in outcome analysis. | Posted | Median | Full Range | hours | Duration of Index Hospitalization, an average of 1-2 days |
|
|
|
| Secondary | Acute Coronary Syndrome | Data from all participants was used in outcome analysis. | Posted | Number | participants | Index Hospitalization discharge through 90 days |
|
|
|
| Secondary | Mortality | Data from all participants was used for outcome analysis. | Posted | Number | participants | Index Hospitalization through 90 days |
|
|
|
| Secondary | Stress Testing-related Adverse Event | Data from all participants was used for outcome analysis | Posted | Number | participants | Index Hospitalization through 90 days |
|
|
|
| 14 |
| 52 |
| 18 |
| 52 |
| EG001 | Inpatient Care | This is the comparison arm. Patients are admitted to the hospital and undergo usual care. | 15 | 53 | 17 | 53 |
| Admission for syncope. | Cardiac disorders | Non-systematic Assessment |
|
| Admission for dyspnea. | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulseless Electrical Activity (PEA) Arrest | Cardiac disorders | Non-systematic Assessment |
|
| Admission for overdose with suicidal ideation and worsening depression | Psychiatric disorders | Non-systematic Assessment |
|
| Admission for laparoscopic radical prostatectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Admission for abdominal pain, nausea, vomiting, and diarrhea. | Gastrointestinal disorders | Non-systematic Assessment |
|
| Admission for abdominal pain. | Gastrointestinal disorders | Non-systematic Assessment |
|
| Admission for motor vehicle collision (MVC) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Underwent cardiac magnetic resonance imaging with evolving myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Admission for atrial fibrillation. | Cardiac disorders | Non-systematic Assessment |
|
| Admission for palpitations and wide-complex tachycardia. | Cardiac disorders | Non-systematic Assessment |
|
| Admission for palpitations and atrial flutter with rapid ventricular rate. | Cardiac disorders | Non-systematic Assessment |
|
| Admission for celiac arteriogram and stenting. | Surgical and medical procedures | Non-systematic Assessment |
|
| Admission for shortness of breath, dysphagia, and chest pain. | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Admission for shortness of breath. | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Developed cerebral vascular accident (CVA) after dobutamine stress echocardiogram | Nervous system disorders | Non-systematic Assessment |
|
| Admission for pneumothorax after lung biopsy. | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Lung biopsy positive for small cell undifferentiated carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Admission for chemotherapy and radiation therapy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Admission for cough, chest pain, and pain with swallowing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Admission for cough and shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Admission for angioedema | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Admission for dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Admission for lower extremity pain and suspected septic hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Admission for severe lactic acidosis secondary to diabetic ketoacidosis (DKA) | Endocrine disorders | Non-systematic Assessment |
|
| Involuntary admission for psychiatric illness | Psychiatric disorders | Non-systematic Assessment |
|
| Admission for seizure, altered consciousness, and facial fractures. | Nervous system disorders | Non-systematic Assessment |
|
| Admission for left arm numbness and chest pressure. | Cardiac disorders | Non-systematic Assessment |
|
| Admission for symptomatic cholelithiasis and laparoscopic cholecystectomy. | Surgical and medical procedures | Non-systematic Assessment |
|
| Admission for dizziness and presyncopal episodes | Nervous system disorders | Non-systematic Assessment |
|
| Acute coronary syndrome after discharge within 90 days of index. | Cardiac disorders | Non-systematic Assessment |
|
| ED visit for syncopal episode. | Nervous system disorders | Non-systematic Assessment |
|
| ED visit for drainage from navel and facial numbness | Nervous system disorders | Non-systematic Assessment |
|
| ED visit for chest pain. | Cardiac disorders | Non-systematic Assessment |
|
| ED visit for abdominal pain. | Gastrointestinal disorders | Non-systematic Assessment |
|
| Negative exercise stress echocardiogram performed | Surgical and medical procedures | Non-systematic Assessment |
|
| ED visit for urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
|
| ED visit for urinary frequency, hyperglycemia, and polydypsia | Renal and urinary disorders | Non-systematic Assessment |
|
| ED visit for back pain and rib pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ED visit for back pain and hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ED visit for abnormal glucose, diabetes, and hypertension | Endocrine disorders | Non-systematic Assessment |
|
| ED visit for high blood pressure | General disorders | Non-systematic Assessment |
|
| Early termination of cardiac MRI due to concern for extensive coronary artery disease | Cardiac disorders | Non-systematic Assessment |
|
| ED visit for lower abdominal pain and rectal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| ED visit for near syncope and mild dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| ED visit for palpitations | Cardiac disorders | Non-systematic Assessment |
|
| ED visit for intoxication | Social circumstances | Non-systematic Assessment |
|
| ED visit for deep facial abscess. | Infections and infestations | Non-systematic Assessment |
|
| ED visit for left knee injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ED visit for chest pain and intoxication | Cardiac disorders | Non-systematic Assessment |
|
| ED visit for headache | Nervous system disorders | Non-systematic Assessment |
|
| ED visit for dyspnea and generalized weakness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| ED visit for upper extremity pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ED visit for abdominal pain, vomiting, and diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| ED visit for bartholin's gland cyst. | Infections and infestations | Non-systematic Assessment |
|
| ED visit for 5th metatarsal fracture and abrasion of the right knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ED visit for knee pain and chest pain. | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ED visit for back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Left against medical advice (AMA) from the ED during index hospitalization | Investigations | Non-systematic Assessment |
|
| ED visit for vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| ED visit for dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| ED visit for injury to nose and face | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ED visit for weakness and numbness | Vascular disorders | Non-systematic Assessment |
|
| ED visit for motor vehicle collision (MVC) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ED visit for lower extremity pain and trouble walking | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ED visit for depression | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D011634 |
| Public Health |
| D004778 | Environment and Public Health |