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

NCT05793567 — Not yet recruiting, 52 participants, Mayo Clinic

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Assessment of Microcirculatory Function in Type 2 Myocardial Infarction

Registry	NCT05793567
Status	Not yet recruiting
Study type	Observational
Enrollment	52 (Estimated)
Sponsor	Mayo Clinic (Other)
Conditions	Myocardial Infarction, Coronary Microvascular Disease
Interventions	Coronary angiogram with coronary reactivity testing (CRT) (Diagnostic test)
Dates	start 2027-01-01 (estimated), primary completion 2028-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2023-03-31, last updated 2026-08-31
Locations	1 site in United States

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
T2MI Patients		Diagnostic Test: 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).
Controls			Patients with atypical chest pain and no obstructive disease on coronary angiogram who have been referred for investigation of suspected CMD and have a clinical indication for CMD testing will be retrospectively enrolled and data collected from a previous routine standard of care coronary angiogram with coronary reactivity testing (CRT) will be utilized.

Coronary angiogram with coronary reactivity testing (CRT) (Diagnostic test): 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.

+Outcome measures

Primary outcomes

Coronary Flow Reserve (CFR) [Baseline]: The CFR will be calculated as a ratio of coronary flow at peak hyperemia /coronary flow at rest.

Secondary outcomes

Backward Compression Wave (BCW) [Baseline]: The BCW is a measure of increased microvascular resistance during systole.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Mayo Clinic Rochester	Rochester, Minnesota	United States

+Investigators

Claire Raphael, MBBS, PhD., Principal investigator, Mayo Clinic