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NCT Number: NCT05793567

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location contact

Claire Raphael, MBBS, PhD

CONTACT

[email protected]

507-255-2445

Claire Raphael, MBBS, PhD

PRINCIPAL_INVESTIGATOR

Ischemic Heart Disease Research Team

CONTACT

507-255-1724

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Coronary Flow Reserve (CFR)

    Time frame: Baseline

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

Secondary outcomes

  1. Backward Compression Wave (BCW)

    Time frame: Baseline

    The BCW is a measure of increased microvascular resistance during systole.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Raphael, MBBS, PhD

CONTACT

[email protected]

507-255-2445

Ischemic Heart Disease Research Team

CONTACT

507-255-1724

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Assessment of Microcirculatory Function in Type 2 Myocardial Infarction

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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