Myocardial InfarctionNCT05793567
A Study of Microcirculatory Function in Type 2 Myocardial Infarction (T2MI)
An observational study of Myocardial Infarction and Coronary Microvascular Disease, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Coronary Microvascular Disease
- What is being tested?
- Coronary angiogram with coronary reactivity testing (CRT)
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ischemic Heart Disease Research Team contact
United States1 site
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Ischemic Heart Disease Research Team, 507-255-1724
Claire Raphael, MBBS, PhD, 507-255-2445, Raphael.Claire@mayo.edu
About this study
Official title: Assessment of Microcirculatory Function in Type 2 Myocardial Infarction
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).
- Being tested
- Coronary angiogram with coronary reactivity testing (CRT)
- Medical subject headings
- Myocardial Infarction, Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Flow Reserve (CFR)
The CFR will be calculated as a ratio of coronary flow at peak hyperemia /coronary flow at rest.
Measured: Baseline
Secondary outcomes (1)
Backward Compression Wave (BCW)
The BCW is a measure of increased microvascular resistance during systole.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire E. Raphael, Mayo Clinic
- Investigators
- Claire Raphael, MBBS, PhD., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793567
- Sponsor's protocol ID
- 22-012721
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No