NCT06323811

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

March 6, 2024

Last Update Submit

March 14, 2024

Conditions

Myocardial Infarction With Non-Obstructive Coronary ArteryMyocarditis AcuteTakotsubo CardiomyopathySpontaneous Coronary Artery DissectionNon ST Elevation Myocardial Infarction

Keywords

MINOCAMINOCA-mimicsCMR3D perfusionadvanced CMR imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • epicardial adipose tissue (EAT)

    4 months (measured either at first or second CMR)

  • cardiovascular events

    5 years

Study Arms (5)

MINOCA

EXPERIMENTAL

Patients with myocardial infarction with non-obstructive coronary artery disease (MINOCA) prospectively investigated with advanced CMR

Diagnostic Test: CMR

Myocarditis

EXPERIMENTAL

Patients with suspected myocarditis prospectively investigated with advanced CMR

Diagnostic Test: CMR

Takotsubo cardiomyopathy

EXPERIMENTAL

Patients with suspected Takotsubo cardiomyopathy prospectively investigated with advanced CMR

Diagnostic Test: CMR

Spontaneous coronary artery dissection (SCAD)

EXPERIMENTAL

Patients with suspected/diagnosed spontaneous coronary artery dissection prospectively investigated with advanced CMR

Diagnostic Test: CMR

NSTEMI

ACTIVE COMPARATOR

Patients with confirmed non-ST elevation myocardial infarction on coronary angiography prospectively investigated with advanced CMR

Diagnostic Test: CMR

Interventions

CMRDIAGNOSTIC_TEST

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

MINOCAMyocarditisNSTEMISpontaneous coronary artery dissection (SCAD)Takotsubo cardiomyopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pacemaker/other devices or claustrophobia
  • severe asthma, chronic obstructive lung or kidney disease
  • acute pulmonary embolism
  • arrhythmia on ECG
  • moderate to severe valvular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

MINOCATakotsubo CardiomyopathyCoronary Artery Dissection, SpontaneousNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCardiomyopathiesVentricular Dysfunction, LeftVentricular Dysfunction

Study Officials

  • Robert Manka, Prof. MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Manka, Prof., MD

CONTACT

+41442551251robert.manka@usz.ch

Verena C Wilzeck, MD

CONTACT

verena.wilzeck@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 5 groups of patients (MINOCA, myocarditis, Takotsubo cardiomyopathy, SCAD, NSTEMI) will undergo CMR with 3D perfusion in the acute setting (within 10 days after the event) and post convalescence (after 3 months)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 21, 2024

Study Start

June 15, 2023

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)