Clinical trial NCT03516578: CMR for Prognosis Assessment in NSTEMI
Official title: Comprehensive Cardiac Magnetic Resonance Imaging For Prognosis Assessment After Non-ST-Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: non-ST-elevation myocardial infarction
cardiac magnetic resonance
prognosis
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the chest pain units of three primary care clinics are screened for study participation.

Brief summary: The prognostic significance of cardiac magnetic resonance (CMR) derived parameters of myocardial and microvascular injury has not been fully elucidated yet in non-ST-Elevation myocardial infarction (NSTEMI) patients. In the present study the investigators aim to comprehensively investigate the prognostic significance of CMR in a prospective, multicentre registry cohort of NSTEMI patients undergoing early percutaneous coronary intervention (PCI). CMR will be performed within the first week following the index event. The primary endpoint is defined as a composite of death, reinfarction, and new congestive heart failure (major adverse cardiac events) at 12 months.


Eligibility criteria: Inclusion Criteria: Patients are eligible for the study if they have: 1) ischemic symptoms in accordance with a possible NSTEMI diagnosis; 2) elevated cardiac troponin levels above the 99th percentile; and 3) identifiable culprit lesion during early invasive coronary angiography with performed PCI.

Exclusion Criteria: 1) STEMI; 2) presence of cardiogenic shock; 3) no identifiable culprit lesion or culprit lesion ineligible for PCI; 4) indication for acute bypass surgery; 5) age less than 18 years or more than 90 years; 6) pregnancy; and 7) typical contraindications to CMR (e.g. severe claustrophobia, implanted pacemakers and internal cardioverter defibrillators, cerebral or intracranial metallic implants, known allergy to gadolinium and creatinine clearance \<30 mL/min).

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Feistritzer HJ, Nanos M, Eitel I, Jobs A, de Waha-Thiele S, Meyer-Saraei R, Freund A, Stiermaier T, Abdel-Wahab M, Lurz P, Reinstadler SJ, Reindl M, Klug G, Metzler B, Desch S, Thiele H. Determinants and prognostic value of cardiac magnetic resonance imaging-derived infarct characteristics in non-ST-elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2020 Jan 1;21(1):67-76. doi: 10.1093/ehjci/jez165.
citation: Feistritzer HJ, Eitel I, Jobs A, de Waha-Thiele S, Stiermaier T, Abdel-Wahab M, Lurz P, Reinstadler SJ, Reindl M, Klug G, Metzler B, Desch S, Thiele H. Impact of smoking on cardiac magnetic resonance infarct characteristics and clinical outcome in patients with non-ST-elevation myocardial infarction. Int J Cardiovasc Imaging. 2019 Jun;35(6):1079-1087. doi: 10.1007/s10554-019-01556-2. Epub 2019 Feb 15.