Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics (COPE-CMR)

March 14, 2024 updated by: University of Zurich

Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA, Tako-Tsubo, SCAD, Myocarditis and NSTEMI in the Acute Phase and Post Convalescence

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:
          • Robert Manka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MINOCA
Patients with myocardial infarction with non-obstructive coronary artery disease (MINOCA) prospectively investigated with advanced CMR
Diagnostic test: CMR
Advanced CMR imaging including a novel quantitative free-breathing 3D perfusion sequence, 3D LGE imaging and a cine Dixon sequence
Experimental: Myocarditis
Patients with suspected myocarditis prospectively investigated with advanced CMR
Diagnostic test: CMR
Advanced CMR imaging including a novel quantitative free-breathing 3D perfusion sequence, 3D LGE imaging and a cine Dixon sequence
Experimental: Takotsubo cardiomyopathy
Patients with suspected Takotsubo cardiomyopathy prospectively investigated with advanced CMR
Diagnostic test: CMR
Advanced CMR imaging including a novel quantitative free-breathing 3D perfusion sequence, 3D LGE imaging and a cine Dixon sequence
Experimental: Spontaneous coronary artery dissection (SCAD)
Patients with suspected/diagnosed spontaneous coronary artery dissection prospectively investigated with advanced CMR
Diagnostic test: CMR
Advanced CMR imaging including a novel quantitative free-breathing 3D perfusion sequence, 3D LGE imaging and a cine Dixon sequence
Active Comparator: NSTEMI
Patients with confirmed non-ST elevation myocardial infarction on coronary angiography prospectively investigated with advanced CMR
Diagnostic test: CMR
Advanced CMR imaging including a novel quantitative free-breathing 3D perfusion sequence, 3D LGE imaging and a cine Dixon sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial perfusion reserve index
Time Frame: within 10 days and after 3 months after index event
comparison of microvascular function in the acute phase versus post convalescence
within 10 days and after 3 months after index event

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
epicardial adipose tissue (EAT)
Time Frame: 4 months (measured either at first or second CMR)
the amount of epicardial adipose tissue
4 months (measured either at first or second CMR)
cardiovascular events
Time Frame: 5 years
rate of cardiovascular death, myocardial infarction, recurrence of MINOCA, myocarditis, takotsubo cardiomyopathy, SCAD
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

ETH Zurich

Investigators

  • Principal Investigator: Robert Manka, Prof. MD, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPE CMR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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