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

Acute Coronary Syndrome Clinical Trial

— CMR-IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931852
• Other study ID #: IRB00022322
• Secondary ID: 1R01HL118263-01A
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: October 2, 2020

Study information

• Verified date: July 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: October 2, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Intervention

Procedure:
• Cardiac MRI
Participants in the CMR-guided care group will receive a cardiac MRI.

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 )

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 68 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Reduction in invasive angiography.	Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces invasive angiography.	5 years
Secondary	Reduction in coronary revascularization.	Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces coronary revascularization.	5 years
Secondary	Reduction in recurrent cardiac testing.	Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces recurrent cardiac testing.	5 years

External Links

•   Wake Forest Baptist Medical Center