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

Study Description

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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	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	September 2013
Estimated Primary Completion Date :	June 2019
Estimated Study Completion Date :	August 2019

Arms and Interventions

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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

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Primary Outcome Measures :

1. Reduction in composite death, nonfatal myocardial infarction (MI), cardiac-related hospital readmissions, and cardiac-related Emergency Department (ED) visits. [ Time Frame: 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 :

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

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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Contacts

Contact: Stephanie Elliott, BSCR	336-716-5943	sbradsha@wakehealth.edu

Locations

United States, Michigan
William Beaumont Hospital	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Laura Stuecher, RN, BSN laura.stuecher@beaumont.org
Principal Investigator: Carol Clark, MD
United States, Mississippi
University of Mississippi Medical Center	Recruiting
Jackson, Mississippi, United States, 39216
Contact: Margaret H Cruse 601-815-3008 mcruse@umc.edu
Principal Investigator: Alan E Jones, MD
United States, North Carolina
Wake Forest Baptist Medical Center	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Erin Harper, MSHS, CCRP 336-716-2059 erharper@wakehealth.edu
Principal Investigator: Chadwick D Miller, MD, MS
Sub-Investigator: L. Doug Case, PhD
Sub-Investigator: Craig Hamilton, PhD
Sub-Investigator: W. Gregory Hundley, MD
Sub-Investigator: Michael Kutcher, MD
Sub-Investigator: Simon Mahler, MD, MS
United States, Ohio
The Ohio State University Wexner Medical Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Michael Hill, RN, BSN 614-293-6185 michael.hill@osumc.edu
Principal Investigator: Jeffrey Caterino, MD

Sponsors and Collaborators

Wake Forest University Health Sciences

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Chadwick Miller, MD, MS	WFBMC

More Information

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Additional Information:

Wake Forest Baptist Medical Center 

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Responsible Party:	Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT01931852 History of Changes
Other Study ID Numbers:	IRB00022322; 1R01HL118263-01A1 ( U.S. NIH Grant/Contract )
First Posted:	August 29, 2013
Last Update Posted:	December 5, 2017
Last Verified:	December 2017

Keywords provided by Wake Forest University Health Sciences:

Acute Coronary Syndrome; Chest pain; Cardiac MRI; Risk Stratification	Emergency Department; Elevated Troponin; Troponin; Non-ST Elevation Myocardial Infarction

Additional relevant MeSH terms:

Acute Coronary Syndrome; Chest Pain; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases	Vascular Diseases; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms