Clinical trial NCT06323811: Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics
Official title: Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA, Tako-Tsubo, SCAD, Myocarditis and NSTEMI in the Acute Phase and Post Convalescence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction With Non-Obstructive Coronary Artery
Myocarditis Acute
Takotsubo Cardiomyopathy
Spontaneous Coronary Artery Dissection
Non ST Elevation Myocardial Infarction
Keywords: MINOCA
MINOCA-mimics
CMR
3D perfusion
advanced CMR imaging
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich
First posted: 2024-03-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Myocardial perfusion reserve index
timeFrame: within 10 days and after 3 months after index event
Secondary outcomes:
measure: epicardial adipose tissue (EAT)
timeFrame: 4 months (measured either at first or second CMR)
measure: cardiovascular events
timeFrame: 5 years
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Robert Manka, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: