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

This study is currently recruiting participants.
Verified March 2017 by Chadwick Miller, Wake Forest University Health Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT01931852
First Posted: August 29, 2013
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Chadwick Miller, Wake Forest University Health Sciences
  Purpose
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 Intervention
Acute Coronary Syndrome Chest Pain Procedure: Cardiac MRI Other: ACC/AHA Guideline adherent care

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chadwick Miller, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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:
  • Reduction in invasive angiography. [ Time Frame: 5 years ]
    Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces invasive angiography.

  • Reduction in coronary revascularization. [ Time Frame: 5 years ]
    Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces coronary revascularization.

  • 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.


Estimated Enrollment: 312
Actual Study Start Date: September 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 )

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931852


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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Responsible Party: Chadwick Miller, Professor, 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 Submitted: August 26, 2013
First Posted: August 29, 2013
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Chadwick Miller, 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


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