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NCT05793567 Clinical Trial

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

Myocardial Infarction Clinical Trial

Official title:
Assessment of Microcirculatory Function in Type 2 Myocardial Infarction

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05793567
Other study ID # 22-012721
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2024
Est. completion date April 2025

Study information
Verified date February 2024
Source Mayo Clinic
Contact Ischemic Heart Disease Research Team
Phone 507-255-1724
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 52
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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) 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Coronary angiogram with coronary reactivity testing (CRT)
CRT is an angiography procedure (using X-ray) to examine the small blood vessels in the heart and how they respond to three drugs (adenosine, acetylcholine and nitroglycerin) as per clinical protocol.

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Coronary Flow Reserve (CFR) The CFR will be calculated as a ratio of coronary flow at peak hyperemia /coronary flow at rest. Baseline
Secondary Backward Compression Wave (BCW) The BCW is a measure of increased microvascular resistance during systole. Baseline
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