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Not yet recruiting NCT05793567

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

Observational Myocardial Infarction Coronary Microvascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coronary angiogram with coronary reactivity testing (CRT).
Who it may be relevant to
Registry conditions: Myocardial Infarction, Coronary Microvascular Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of Microcirculatory Function in Type 2 Myocardial Infarction

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Coronary Flow Reserve (CFR) [Time frame: Baseline]
Secondary outcome measures (1)
  • Backward Compression Wave (BCW) [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Mayo Clinic Rochester — Rochester

Identifiers

NCT: NCT05793567 · 22-012721

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗