A Study of Microcirculatory Function in Type 2 Myocardial Infarction (T2MI)

Not yet recruiting

• Conditions: Myocardial Infarction; Coronary Microvascular Disease
• Interventions: Diagnostic Test: Coronary angiogram with coronary reactivity testing (CRT)

• Registration Number: NCT05793567
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to find out if patients with Type 2 Myocardial Infarction (T2MI) without significant epicardial coronary artery disease (CAD) have a greater chance of having coronary microvascular disease (CMD).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-03-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Study Start: 2024-11
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Ability to give informed consent
• Structurally normal heart (normal LV and RV function, no more than mild valvular heart disease)
• For controls: atypical chest pain with indication for CMD testing
• For T2MI: meet criteria for T2MI according to the 4th Universal definition of MI (rise/fall of troponin with at least 1 value >99th centile+ evidence of symptoms or signs of myocardial ischemia)

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Exclusion Criteria

• Acute coronary event (evidence of plaque rupture, fissure or dissection on coronary angiogram)
• Known to have angiographically significant CAD/pressure wire positive for epicardial CAD
• Inability to receive heparin products
• Allergy/contraindication to acetylcholine/adenosine/nitroglycerine products
• Prior coronary artery bypass grafting
• Pregnancy (if sexually active woman of reproductive age, need negative pregnancy test prior to proceeding with coronary angiography - this is standard of care in cath lab)
• Asthma with prior ICU admission due to bronchospasm/need for invasive ventilation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T2MI Patients	Coronary angiogram with coronary reactivity testing (CRT)	Patients with T2MI and no epicardial coronary stenosis \>50% will be prospectively enrolled and undergo a routine standard of care coronary angiogram with coronary reactivity testing (CRT).

Primary Outcome Measures

Name	Time	Method
Coronary Flow Reserve (CFR)	Baseline	The CFR will be calculated as a ratio of coronary flow at peak hyperemia /coronary flow at rest.

Secondary Outcome Measures

Name	Time	Method
Backward Compression Wave (BCW)	Baseline	The BCW is a measure of increased microvascular resistance during systole.

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States