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

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05793567

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Coronary Microvascular Disease	Diagnostic Test: Coronary angiogram with coronary reactivity testing (CRT)

Study Design

Study Type:

Observational

Anticipated Enrollment :

52 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Assessment of Microcirculatory Function in Type 2 Myocardial Infarction

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
T2MI Patients 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).	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.
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.

Arm

Intervention/Treatment

T2MI Patients

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).

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Claire Raphael, MBBS, PhD., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Claire E. Raphael, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05793567

Other Study ID Numbers:

22-012721

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocardial Infarction

Microvascular Angina

Infarction

Study Results

No Results Posted as of Mar 31, 2023