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

NCT05793567 | Not Yet Recruiting

• 1 other identifier: 22-012721
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Myocardial Infarction; Coronary Microvascular Disease

Outcome Measures

Primary Outcomes (1)

• Coronary Flow Reserve (CFR)

  The CFR will be calculated as a ratio of coronary flow at peak hyperemia /coronary flow at rest.

  Baseline

Secondary Outcomes (1)

• Backward Compression Wave (BCW)

  Baseline

Study Arms (2)

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)

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.

Interventions

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.

T2MI Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects receiving care at Mayo Clinic in Rochester, MN identified with T2MI and controls with atypical chest pain with indication for CMD testing will be enrolled in this study. Both groups will have no epicardial coronary stenosis \>50% or obstructive disease.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Myocardial Infarction; Microvascular Angina

Interventions

Coronary Angiography

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests

Study Officials

• Claire Raphael, MBBS, PhD.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ischemic Heart Disease Research Team

CONTACT

507-255-1724

Claire Raphael, MBBS, PhD

CONTACT

507-255-2445; Raphael.Claire@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 31, 2023
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)