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. (see Contacts and Locations)
Verified May 2014 by Wake Forest Baptist Health
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Chadwick Miller, Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT01931852
First received: August 26, 2013
Last updated: May 29, 2014
Last verified: May 2014
  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 Phase
Acute Coronary Syndrome
Chest Pain
Procedure: Cardiac MRI
Other: ACC/AHA Guideline adherent care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Wake Forest Baptist Health:

Primary Outcome Measures:
  • Reduction in composite death, nonfatal myocardial infarction (MI), and cardiac related readmission [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces the composite of death, nonfatal MI, and cardiac-related hospital readmission over time.


Secondary Outcome Measures:
  • Reduction in invasive angiography. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces invasive angiography.

  • Reduction in coronary revascularization. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces coronary revascularization.

  • Reduction in recurrent cardiac testing. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces recurrent cardiac testing.

  • Reduction in cardiac-related ED visits. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces cardiac-related ED visits.


Estimated Enrollment: 312
Study Start Date: September 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2016 (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.
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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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 ED 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
  • Inducible cardiac ischemia without subsequent revascularization, known to the care providers at the time of assessment
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931852

Contacts
Contact: Erin Harper, MSHS, CCRP 336-716-2059 erharper@wakehealth.edu

Locations
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: Yaorong Ge, PhD         
Sub-Investigator: Craig Hamilton, PhD         
Sub-Investigator: W. Gregory Hundley, MD         
Sub-Investigator: Michael Kutcher, MD         
Sub-Investigator: Simon Mahler, MD, MS         
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: Chadwick Miller, MD, MS WFBMC
  More Information

Additional Information:
Publications:
Wright RS, Anderson JL, Adams CD, Bridges CR, Casey DE Jr, Ettinger SM, Fesmire FM, Ganiats TG, Jneid H, Lincoff AM, Peterson ED, Philippides GJ, Theroux P, Wenger NK, Zidar JP, Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS. 2011 ACCF/AHA focused update of the Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction (updating the 2007 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 May 10;57(19):1920-59. doi: 10.1016/j.jacc.2011.02.009. Epub 2011 Mar 28. Erratum in: J Am Coll Cardiol. 2011 May 10;57(19):1960.
Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007 Aug 14;116(7):e148-304. Epub 2007 Aug 6. No abstract available. Erratum in: Circulation. 2008 Mar 4;117(9):e180.
Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction, Jaffe AS, Apple FS, Galvani M, Katus HA, Newby LK, Ravkilde J, Chaitman B, Clemmensen PM, Dellborg M, Hod H, Porela P, Underwood R, Bax JJ, Beller GA, Bonow R, Van der Wall EE, Bassand JP, Wijns W, Ferguson TB, Steg PG, Uretsky BF, Williams DO, Armstrong PW, Antman EM, Fox KA, Hamm CW, Ohman EM, Simoons ML, Poole-Wilson PA, Gurfinkel EP, Lopez-Sendon JL, Pais P, Mendis S, Zhu JR, Wallentin LC, Fernández-Avilés F, Fox KM, Parkhomenko AN, Priori SG, Tendera M, Voipio-Pulkki LM, Vahanian A, Camm AJ, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Morais J, Brener S, Harrington R, Morrow D, Lim M, Martinez-Rios MA, Steinhubl S, Levine GN, Gibler WB, Goff D, Tubaro M, Dudek D, Al-Attar N. Universal definition of myocardial infarction. Circulation. 2007 Nov 27;116(22):2634-53. Epub 2007 Oct 19.
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24.
Wong DTL, Das R, Leung MC, et al. Safety of Adenosine Stress Cardiac MRI (AS-CMR) Early after Acute ST Elevation Myocardial Infarction (STEMI) Post-primary Angioplasty. Heart, Lung and Circulation Abstracts for the Cardiac Society of Australia and New Zealand Annual Scientific Meeting and the International Society for Heart Research, Australasian Section, Annual Scientific Meeting 2009;18:S51.

Responsible Party: Chadwick Miller, Associate Professor, Wake Forest Baptist Health
ClinicalTrials.gov Identifier: NCT01931852     History of Changes
Other Study ID Numbers: IRB00022322, 1R01HL118263-01A1
Study First Received: August 26, 2013
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Wake Forest Baptist Health:
Acute Coronary Syndrome
Chest pain
Cardiac MRI
Risk Stratification
Emergency Department
Elevated Troponin
Troponin
Non-ST Elevation Myocardial Infarction

Additional relevant MeSH terms:
Chest Pain
Acute Coronary Syndrome
Pain
Signs and Symptoms
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014