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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06323811
Other study ID # COPE CMR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 15, 2023
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source University of Zurich
Contact Robert Manka, Prof., MD
Phone +41442551251
Email robert.manka@usz.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR. The present study aims to: - assess the microvascular function with a novel quantitative 3D myocardial perfusion imaging approach in the acute phase and post-convalescence - refine the role and diagnostic potential of advanced quantitative CMR imaging - assess the potential prognostic significance of microvascular dysfunction and epicardial adipose tissue on cardiovascular outcomes Participants will undergo advanced CMR imaging in the acute setting (within 10 days after event) and post convalescence (after 3 months).


Description:

Advanced CMR includes a novel free-breathing motion-informed locally low-rank quantitative 3D myocardial perfusion imaging. Perfusion imaging will be compared with 3D late gadolinium enhancement (LGE) imaging. A cine Dixon sequence is performed for the assessment of epicardial adipose tissue (EAT).


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - acute presentation with signs/symptoms of acute coronary syndrome or myocarditis - elevated cardiac biomarkers - no signficant coronary artery disease on coronary angiogram or coronary CT Exclusion Criteria: - pacemaker/other devices or claustrophobia - severe asthma, chronic obstructive lung or kidney disease - acute pulmonary embolism - arrhythmia on ECG - moderate to severe valvular disease

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
CMR
Advanced CMR imaging including a novel quantitative free-breathing 3D perfusion sequence, 3D LGE imaging and a cine Dixon sequence

Locations

Country Name City State
Switzerland University Hospital Zurich Zürich

Sponsors (2)

Lead Sponsor Collaborator
University of Zurich ETH Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myocardial perfusion reserve index comparison of microvascular function in the acute phase versus post convalescence within 10 days and after 3 months after index event
Secondary epicardial adipose tissue (EAT) the amount of epicardial adipose tissue 4 months (measured either at first or second CMR)
Secondary cardiovascular events rate of cardiovascular death, myocardial infarction, recurrence of MINOCA, myocarditis, takotsubo cardiomyopathy, SCAD 5 years
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