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

February 1, 2024 updated by: Claire E. Raphael, Mayo Clinic

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ischemic Heart Disease Research Team
  • Phone Number: 507-255-1724

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
        • Contact:
          • Ischemic Heart Disease Research Team
          • Phone Number: 507-255-1724
        • Contact:
        • Principal Investigator:
          • Claire Raphael, MBBS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Backward Compression Wave (BCW)
Time Frame: Baseline
The BCW is a measure of increased microvascular resistance during systole.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Claire Raphael, MBBS, PhD., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-012721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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