CMR for Prognosis Assessment in NSTEMI

NCT ID: NCT03516578

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2018-03-28

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiac magnetic resonance imaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart Center Leipzig - University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 31518417 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30771036 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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