Cardiac Magnetic Resonance Imaging Strategy for the Management of Patients With Acute Chest Pain and Detectable to Elevated Troponin (CMR-IMPACT)
3 maart 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
312
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Michigan
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Royal Oak, Michigan, Verenigde Staten, 48073
- William Beaumont Hospital
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39216
- University of Mississippi Medical Center
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest Baptist Medical Center
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Ohio
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Columbus, Ohio, Verenigde Staten, 43210
- The Ohio State University Wexner Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
21 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: CMR-guided care
Participants in this group will receive a cardiac MRI
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Participants in the CMR-guided care group will receive a cardiac MRI.
Andere namen:
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Actieve vergelijker: Invasive-based guideline-adherent care
Participants will receive care adherent with current ACC/AHA guideline recommendations.
( ACC/AHA Guideline adherent care )
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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 )
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Reduction in composite death, nonfatal myocardial infarction (MI), cardiac-related hospital readmissions, and cardiac-related Emergency Department (ED) visits.
Tijdsspanne: 5 years
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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.
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5 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Reduction in invasive angiography.
Tijdsspanne: 5 years
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Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces invasive angiography.
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5 years
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Reduction in coronary revascularization.
Tijdsspanne: 5 years
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Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces coronary revascularization.
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5 years
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Reduction in recurrent cardiac testing.
Tijdsspanne: 5 years
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Test whether a CMR-guided strategy (versus invasive-based guideline-adherent strategy) reduces recurrent cardiac testing.
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5 years
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Chadwick Miller, MD, MS, WFBMC
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2013
Primaire voltooiing (Werkelijk)
29 juli 2020
Studie voltooiing (Werkelijk)
2 oktober 2020
Studieregistratiedata
Eerst ingediend
26 augustus 2013
Eerst ingediend dat voldeed aan de QC-criteria
28 augustus 2013
Eerst geplaatst (Schatting)
29 augustus 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 maart 2022
Laatste update ingediend die voldeed aan QC-criteria
3 maart 2022
Laatst geverifieerd
1 juli 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00022322
- 1R01HL118263-01A1 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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