Myocardial Infarction Clinical Trial
Official title:
Assessment of Microcirculatory Function in Type 2 Myocardial Infarction
NCT number | NCT05793567 |
Other study ID # | 22-012721 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 2024 |
Est. completion date | April 2025 |
Verified date | February 2024 |
Source | Mayo Clinic |
Contact | Ischemic Heart Disease Research Team |
Phone | 507-255-1724 |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Not yet recruiting |
Enrollment | 52 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coronary Flow Reserve (CFR) | The CFR will be calculated as a ratio of coronary flow at peak hyperemia /coronary flow at rest. | Baseline | |
Secondary | Backward Compression Wave (BCW) | The BCW is a measure of increased microvascular resistance during systole. | Baseline |
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