CMR-IMPACT: Cardiac Magnetic Resonance Imaging Strategy for the Management of Patients With Acute Chest Pain and Detectable to Elevated Troponin

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01931852

Collaborator

National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)

312

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Chest Pain	Procedure: Cardiac MRI Other: ACC/AHA Guideline adherent care	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

312 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Cardiac Magnetic Resonance Imaging Strategy for the Management of Patients With Acute Chest Pain and Detectable to Elevated Troponin

Actual Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Jul 29, 2020

Actual Study Completion Date :

Oct 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CMR-guided care Participants in this group will receive a cardiac MRI	Procedure: Cardiac MRI Participants in the CMR-guided care group will receive a cardiac MRI. Other Names: CMR Cardiac Magnetic Resonance Imaging
Active Comparator: Invasive-based guideline-adherent care Participants will receive care adherent with current ACC/AHA guideline recommendations. ( ACC/AHA Guideline adherent care )	Other: ACC/AHA Guideline adherent care 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 )

Arm

Intervention/Treatment

Experimental: CMR-guided care

Participants in this group will receive a cardiac MRI

Procedure: Cardiac MRI

Participants in the CMR-guided care group will receive a cardiac MRI.

Other Names:

CMR

Cardiac Magnetic Resonance Imaging

Active Comparator: Invasive-based guideline-adherent care

Participants will receive care adherent with current ACC/AHA guideline recommendations. ( ACC/AHA Guideline adherent care )

Other: ACC/AHA Guideline adherent care

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 )

Outcome Measures

Primary Outcome Measures

Reduction in composite death, nonfatal myocardial infarction (MI), cardiac-related hospital readmissions, and cardiac-related Emergency Department (ED) visits. [5 years]
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.

Secondary Outcome Measures

Reduction in invasive angiography. [5 years]
Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces invasive angiography.
Reduction in coronary revascularization. [5 years]
Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces coronary revascularization.
Reduction in recurrent cardiac testing. [5 years]
Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces recurrent cardiac testing.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age greater than or equal to 21 years of age at the time of enrollment
Symptoms consistent with acute coronary syndrome
At least 1 troponin > lower limit of detection and ≤1.0 ng/ml within 6 hours of the initial evaluation

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
This may be manifested by a recent or concurrent rise in serum creatinine, or a reduction in baseline creatinine clearance.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
2	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
3	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
4	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210