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

NCT ID: NCT05793567

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-08-31

Study Completion Date

2027-04-30

Brief Summary

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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

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Conditions

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Myocardial Infarction Coronary Microvascular Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

Coronary angiogram with coronary reactivity testing (CRT)

Intervention Type 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.

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Claire E. Raphael

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claire Raphael, MBBS, PhD.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Ischemic Heart Disease Research Team

Role: CONTACT

507-255-1724

Claire Raphael, MBBS, PhD

Role: CONTACT

507-255-2445

Facility Contacts

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Ischemic Heart Disease Research Team

Role: primary

507-255-1724

Claire Raphael, MBBS, PhD

Role: backup

507-255-2445

Related Links

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Other Identifiers

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22-012721

Identifier Type: -

Identifier Source: org_study_id

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