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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)

3. marts 2022 opdateret af: Wake Forest University Health Sciences
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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

312

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Michigan
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest Baptist Medical Center
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University Wexner Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CMR-guided care
Participants in this group will receive a cardiac MRI
Participants in the CMR-guided care group will receive a cardiac MRI.
Andre navne:
  • CMR
  • Cardiac Magnetic Resonance Imaging
Aktiv komparator: Invasive-based guideline-adherent care
Participants will receive care adherent with current ACC/AHA guideline recommendations. ( 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 )

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Chadwick Miller, MD, MS, WFBMC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2013

Primær færdiggørelse (Faktiske)

29. juli 2020

Studieafslutning (Faktiske)

2. oktober 2020

Datoer for studieregistrering

Først indsendt

26. august 2013

Først indsendt, der opfyldte QC-kriterier

28. august 2013

Først opslået (Skøn)

29. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. marts 2022

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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