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

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ClinicalTrials.gov Identifier: NCT05793567

Recruitment Status : Not yet recruiting

First Posted : March 31, 2023

Last Update Posted : February 2, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Claire E. Raphael, Mayo Clinic

Tracking Information

First Submitted Date

March 20, 2023

First Posted Date

March 31, 2023

Last Update Posted Date

February 2, 2024

Estimated Study Start Date

November 2024

Estimated Primary Completion Date

April 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

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.

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

Backward Compression Wave (BCW) [ Time Frame: Baseline ]

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

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

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

Official Title

Assessment of Microcirculatory Function in Type 2 Myocardial Infarction

Brief 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).

Detailed Description

Not Provided

Study Type

Observational

Study Design

Observational Model: Case-Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition

Myocardial Infarction
Coronary Microvascular Disease

Intervention

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.

Study Groups/Cohorts

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).

Intervention: 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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Not yet recruiting

Estimated Enrollment

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

April 2025

Estimated Primary Completion Date

April 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact: Ischemic Heart Disease Research Team	507-255-1724
Contact: Claire Raphael, MBBS, PhD	507-255-2445	Raphael.Claire@mayo.edu

Listed Location Countries

United States

Removed Location Countries

Administrative Information

NCT Number

NCT05793567

Other Study ID Numbers

22-012721

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Current Responsible Party

Claire E. Raphael, Mayo Clinic

Original Responsible Party

Same as current

Current Study Sponsor

Mayo Clinic

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Principal Investigator:

Claire Raphael, MBBS, PhD.

Mayo Clinic

PRS Account

Mayo Clinic

Verification Date

February 2024

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