Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics

NCT ID: NCT06323811

Last Updated: 2024-03-21

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

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2025-12-31

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Myocardial Infarction With Non-Obstructive Coronary Artery Myocarditis Acute Takotsubo Cardiomyopathy Spontaneous Coronary Artery Dissection Non ST Elevation Myocardial Infarction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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MINOCA

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

Group Type EXPERIMENTAL

CMR

Intervention Type DIAGNOSTIC_TEST

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

Myocarditis

Patients with suspected myocarditis prospectively investigated with advanced CMR

Group Type EXPERIMENTAL

CMR

Intervention Type DIAGNOSTIC_TEST

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

Takotsubo cardiomyopathy

Patients with suspected Takotsubo cardiomyopathy prospectively investigated with advanced CMR

Group Type EXPERIMENTAL

CMR

Intervention Type DIAGNOSTIC_TEST

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

Spontaneous coronary artery dissection (SCAD)

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

Group Type EXPERIMENTAL

CMR

Intervention Type DIAGNOSTIC_TEST

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

NSTEMI

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

Group Type ACTIVE_COMPARATOR

CMR

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CMR

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ETH Zurich

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Manka, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Robert Manka, Prof., MD

Role: CONTACT

+41442551251

Verena C Wilzeck, MD

Role: CONTACT

Facility Contacts

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Robert Manka

Role: primary

Other Identifiers

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COPE CMR

Identifier Type: -

Identifier Source: org_study_id

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