COMPLETED

MCG as a Noninvasive Diagnostic Strategy for Suspected INOCA (MICRO2)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A prospective, multicenter, observational, single-arm trial to validate CardioFlux MCG's ability to diagnose myocardial ischemia caused by coronary microvascular dysfunction in patients with suspected ischemia and confirmed no obstructive coronary artery disease (suspected INOCA) by using diagnostic measures of coronary flow reserve (CFR) via invasive angiography as a reference standard for diagnosis.

Official Title

Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia With No Obstructive Coronary Artery Disease

Quick Facts

Study Start:2024-06-03
Study Completion:2025-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06212466

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Zoe E Swann, PhD
STUDY_DIRECTOR
Genetesis Inc.

Study Locations (Sites)

University of Florida, Division of Cardiovascular Medicine
Gainesville, Florida, 32610
United States
Saint Elizabeth Medical Center
Edgewood, Kentucky, 41017
United States
Ascension St. John Hospital
Detroit, Michigan, 48236
United States
Mayo Clinic, Cardiovascular Research
Rochester, Minnesota, 55905
United States
St. Luke's Health System, Cardiovascular Research
Kansas City, Missouri, 64111
United States
Hackensack Meridian Mountainside Medical Center
Montclair, New Jersey, 07042
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
Cleveland Clinic, Cardiovascular Medicine Research
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Genetesis Inc.

  • Zoe E Swann, PhD, STUDY_DIRECTOR, Genetesis Inc.

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 Registration Dates

Study Start Date2024-06-03
Study Completion Date2025-04-15

Study Record Updates

Study Start Date2024-06-03
Study Completion Date2025-04-15

Terms related to this study

Keywords Provided by Researchers

  • Magnetocardiography
  • CardioFlux
  • Coronary Flow Reserve

Additional Relevant MeSH Terms

  • Ischemic Heart Disease
  • Coronary Microvascular Disease
  • Angina
  • Myocardial Ischemia