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CMD negative for Coronary Artery Disease (MICRO(T) Trial)

N/A
Recruiting
Led By Odayme E Quesada, MD
Research Sponsored by Genetesis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

MICRO(T) Trial Summary

This study will be an observational registry to investigate the ability of magnetocardiography (MCG) in determining the presence of myocardial ischemia with the absence of obstructive coronary artery disease, by using an invasive reference standard coronary flow reserve (CFR) measured using thermodilution for diagnosis. Up to 200 participants in a 1:1 ratio of CMD positive to CMD negative will be enrolled. The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with cloud processing software. A CardioFlux scan appointment shall last approximately 15 minutes in duration and include a patient questionnaire following the scan.

Eligible Conditions
  • Coronary Artery Disease
  • Coronary Microvascular Disease
  • Angina

MICRO(T) Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detection of Myocardial Ischemia in the Absence of Obstructive Coronary Artery Disease (INOCA)
Secondary outcome measures
Electrocardiogram (EKG)
Invasive Coronary Flow Reserve (CFR) and Angiogram Outcomes
Participant Demographic Characteristics
+1 more

MICRO(T) Trial Design

2Treatment groups
Experimental Treatment
Group I: CMD positiveExperimental Treatment1 Intervention
This group comprises participants demonstrating signs of Coronary Microvascular Disease (CMD), defined by a coronary flow reserve (CFR) measurement of less than 2.5. Participants in this category are experiencing myocardial ischemia without significant blockages in their coronary arteries.
Group II: CMD negativeExperimental Treatment1 Intervention
Participants in this group exhibit no signs of Coronary Microvascular Disease (CMD), as evidenced by a CFR measurement equal to or greater than 2.5. This group serves as the comparative reference, representing individuals without CMD-related myocardial ischemia.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CardioFlux Magnetocardiography
2020
N/A
~140

Find a Location

Who is running the clinical trial?

Genetesis Inc.Lead Sponsor
12 Previous Clinical Trials
2,293 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
430 Patients Enrolled for Coronary Artery Disease
Odayme E Quesada, MDPrincipal InvestigatorThe Christ Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR
2023. "MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139094.
All > Cleveland
~133 spots leftby Apr 2025
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