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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL118263-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The broad, long-term objective is to improve outcomes by optimizing healthcare delivery processes for patients with detectable to elevated serum troponin. This clinical trial involving emergency department (ED) patients with intermediate to high-risk chest pain and detectable to minimally elevated serum troponin within 6 hours of evaluation.
In the evaluation of patients with possible acute coronary syndrome, serum troponin measurement is a critical determinant of myocardial necrosis. The recent implementation of high-sensitivity troponin assays allows detection of lower levels of serum troponin than possible with less sensitive predecessors. As a result, 30% more patients are diagnosed with myocardial injury but the optimal management of these patients is unclear. Guidelines from the American Heart Association and American College of Cardiology recommend an invasive management strategy (Class 1a) but acknowledge that data supporting an invasive strategy were based on less sensitive troponin assays than those available today. Clinical trials of an invasive strategy in patients with detectable to minimally elevated troponin values demonstrate conflicting results. Observational data suggest aggressive medical therapy rather than increased use of revascularization drives improved outcomes in these patients. Meanwhile, these patients with minimally elevated serum troponin values have experienced a near doubling in the rate of invasive angiography. In short, it is uncertain whether patients with detectable to minimally elevated troponin results benefit from current invasive-based care strategies. As an alternative, cardiac magnetic resonance (CMR) imaging is highly accurate for detecting significant coronary disease and the need for coronary revascularization.
Objectives: The broad, long-term objective is to improve outcomes by optimizing healthcare delivery processes for patients with detectable to elevated serum troponin. To achieve this goal, we propose a clinical trial (n=312) involving emergency department patients with intermediate to high-risk chest pain and detectable to minimally elevated serum troponin within 6 hours of evaluation.
Methods: Participants will be randomized to one of two care strategies: a) invasive-based guideline-adherent strategy, or b) CMR-guided. Outcomes will be assessed over an average of 2.3 years. The specific aims of this proposal are 1) Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces the composite of death, nonfatal myocardial infarction, and cardiac-related hospital readmission over the study duration, and 2) Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces invasive angiography, coronary revascularization, recurrent cardiac testing, and cardiac-related emergency department visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMR-guided care | Experimental | Participants in this group will receive a cardiac MRI |
|
| Invasive-based guideline-adherent care | Active Comparator | Participants will receive care adherent with current ACC/AHA guideline recommendations. ( ACC/AHA Guideline adherent care ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac MRI | Procedure | Participants in the CMR-guided care group will receive a cardiac MRI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in composite death, nonfatal myocardial infarction (MI), cardiac-related hospital readmissions, and cardiac-related Emergency Department (ED) visits. | Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces the composite of death, nonfatal MI, cardiac-related hospital readmission, and cardiac-related ED visits over time. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in invasive angiography. | Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces invasive angiography. | 5 years |
| Reduction in coronary revascularization. |
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Inclusion Criteria:
Exclusion Criteria:
Any troponin >1.0 ng/ml at the time of consent
New ST-segment elevation (≥ 1 mV) or depression (≥ 2 mV)
Hemodynamic instability (symptomatic systolic BP <90 mmHg, dysrhythmia)
Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization
Known severe multi-vessel CAD previously determined to be not amendable to mechanical intervention
Coronary revascularization in the past 6 months
Contra-indications to magnetic resonance imaging Examples: Unable to lie flat, pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, severe claustrophobia, pregnancy
Life expectancy less than 12 months
Increased risk for nephrogenic systemic fibrosis i. Creatinine clearance < 30 ml/min at the time of enrollment ii. clinical concern for acute kidney injury and/or acute renal failure* iii. Hepato-renal syndrome or chronic liver disease with a creatinine clearance of <60 ml/min at the time of enrollment iv. History of liver, heart, or kidney transplant
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| Name | Affiliation | Role |
|---|---|---|
| Chadwick Miller, MD, MS | WFBMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States | ||
| University of Mississippi Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18958996 | Background | Pitts SR, Niska RW, Xu J, Burt CW. National Hospital Ambulatory Medical Care Survey: 2006 emergency department summary. Natl Health Stat Report. 2008 Aug 6;(7):1-38. | |
| 16387209 | Background | Christenson J, Innes G, McKnight D, Thompson CR, Wong H, Yu E, Boychuk B, Grafstein E, Rosenberg F, Gin K, Anis A, Singer J. A clinical prediction rule for early discharge of patients with chest pain. Ann Emerg Med. 2006 Jan;47(1):1-10. doi: 10.1016/j.annemergmed.2005.08.007. Epub 2005 Oct 19. |
| Label | URL |
|---|---|
| Wake Forest Baptist Medical Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2018 | Nov 20, 2020 |
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| ACC/AHA Guideline adherent care | Other | Participants in the invasive-based guideline-adherent care group will receive care adherent with current American College of Cardiology / American Heart Association (ACC/AHA) guideline recommendations. ( ACC/AHA Guideline adherent care ) |
|
Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces coronary revascularization.
| 5 years |
| Reduction in recurrent cardiac testing. | Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces recurrent cardiac testing. | 5 years |
| Jackson |
| Mississippi |
| 39216 |
| United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
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| 37339173 | Derived | Miller CD, Mahler SA, Snavely AC, Raman SV, Caterino JM, Clark CL, Jones AE, Hall ME, Koehler LE, Lovato JF, Hiestand BC, Stopyra JP, Park CJ, Vasu S, Kutcher MA, Hundley WG. Cardiac Magnetic Resonance Imaging Versus Invasive-Based Strategies in Patients With Chest Pain and Detectable to Mildly Elevated Serum Troponin: A Randomized Clinical Trial. Circ Cardiovasc Imaging. 2023 Jun;16(6):e015063. doi: 10.1161/CIRCIMAGING.122.015063. Epub 2023 Jun 20. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002637 | Chest Pain |
| D004630 | Emergencies |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
Not provided
Not provided