CMR for Prognosis Assessment in NSTEMI

Myocardial Infarction Clinical Trial

Official title:

Comprehensive Cardiac Magnetic Resonance Imaging For Prognosis Assessment After Non-ST-Elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516578
• Other study ID #: 1
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: March 28, 2018

Study information

• Verified date: May 2018
• Source: Heartcenter Leipzig GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: March 28, 2018
• Est. primary completion date: March 28, 2018
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction

Intervention

Other:
• Cardiac magnetic resonance imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heartcenter Leipzig GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	Composite of death, reinfarction and new congestive heart failure	12 months