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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05793567
Recruitment Status : Not yet recruiting
First Posted : March 31, 2023
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
Claire E. Raphael, Mayo Clinic

Study Description
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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).

Condition or disease Intervention/treatment
Myocardial Infarction Coronary Microvascular Disease Diagnostic Test: Coronary angiogram with coronary reactivity testing (CRT)

Study Design
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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Microcirculatory Function in Type 2 Myocardial Infarction
Estimated Study Start Date : November 2024
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Backward Compression Wave (BCW) [ Time Frame: Baseline ]
    The BCW is a measure of increased microvascular resistance during systole.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05793567


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

Locations
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United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Contact: Ischemic Heart Disease Research Team    507-255-1724      
Contact: Claire Raphael, MBBS, PhD    507-255-2445    Raphael.Claire@mayo.edu   
Principal Investigator: Claire Raphael, MBBS, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Claire Raphael, MBBS, PhD. Mayo Clinic
More Information
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Responsible Party: Claire E. Raphael, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05793567    
Other Study ID Numbers: 22-012721
First Posted: March 31, 2023    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Microvascular Angina
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris