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MCG as a Noninvasive Diagnostic Strategy for Suspected INOCA (MICRO2)
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.
Conditions:
🦠 Ischemic Heart Disease 🦠 Coronary Microvascular Disease 🦠 Angina 🦠 Myocardial Ischemia
🗓️ Study Start (Actual) 3 June 2024
🗓️ Primary Completion (Estimated) 15 December 2024
✅ Study Completion (Estimated) 15 December 2024
👥 Enrollment (Estimated) 135
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Gainesville, Florida, United States
📍 Detroit, Michigan, United States
📍 Rochester, Minnesota, United States
📍 Kansas City, Missouri, United States
📍 Montclair, New Jersey, United States
📍 Cincinnati, Ohio, United States
📍 Cleveland, Ohio, United States
More locations available...

📋 Eligibility Criteria

Description

  • INCLUSION CRITERIA
  • In order to be eligible to participate in this study, an individual must meet all the following criteria:
  • 1. ≥ 18 years of age at the time of enrollment.
  • 2. Willing to provide written informed consent.
  • 3. Signs and symptoms of chest pain prompted further evaluation by a coronary angiogram within the previous 5 years.
  • 4. Invasive CFR (via bolus thermodilution) completed within 180 days, or scheduled within 30 days, of informed consent.
  • 4.1. CFR must be performed in the mid Left Anterior Descending (LAD) vessel.
  • 5. Successfully passing CardioFlux MCG Quality Preview prior to MCG study scan. 5.1. Patients must be able to fit into the device. 5.2. Patients must be able to lie supine for 5 minutes. 5.3. Patients must not have any of the following: 5.3.1. Presence of ferromagnetic metal between the sternal notch and costal margin of the rib cage.
  • 5.3.2. Implanted pacemakers or cardioverter/defibrillators. 5.3.3. Implanted infusion pumps and/or neuro stimulators. 5.3.4. Note: sternotomy wires and stents are acceptable. 5.3.5. Note: Failure to meet inclusion criteria 5.3 will render the MCG scan uninterpretable. However, any patient who may be scanned with the presence of any of the above objects is not at any risk of harm by the device. Prosthetic joints are allowed if the MCG Quality Preview is acceptable.
  • EXCLUSION CRITERIA
  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • 1. Obstructive CAD (either anatomical or physiological) defined as:
  • 1.1. ≥ 70% lesion in any major epicardial or branch vessel by CT or invasive Angiography; 1.2. ≥ 50% lesion in the Left Main (LM) vessel by CT or invasive Angiography; 1.3. or either an FFR\<0.80 or iFR or RFR \<0.89 in the obstructed vessel,
  • 2. Any of the following cardiac pathologies:
  • 2.1. Epicardial spasm. 2.2. History of non-ischemic dilated or hypertrophic cardiomyopathy. 2.3. Suspected myocarditis. 2.4. Documented acute coronary syndrome (ACS) within previous 30 days. 2.5. Known left ventricular ejection fraction (LVEF) \<45% on most recent assessment (can be via ECHO), or hospitalization for Reduced ejection fraction within 180 days. (HFpEF is allowed).
  • 2.6. Currently in atrial fibrillation or atrial flutter at the time of enrollment.
  • 2.7. Complete Bundle Branch Block. 2.8. Known moderate or severe valvular disease (anything besides mild). 2.9. Known severe Left ventricular hypertrophy (LVH) as determined by Echocardiography.
  • 2.10. Dextrocardia.
  • 3. Known estimated glomerular filtration rate (eGFR) \<30 ml/min.
  • 4. Life expectancy \<3-yrs. due to non-cardiovascular comorbidity.
  • 5. Concurrent enrollment in a clinical trial in which therapeutic intervention is administered within 30 days of enrollment.
  • 6. Prior enrollment in MICRO 1.0 and/or MICRO(T) data development study.
  • 7. Pregnancy.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 29 November 2023
  • First Submitted that Met QC Criteria 8 January 2024
  • First Posted 18 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 July 2024
  • Last Update Posted 15 July 2024
  • Last Verified July 2024
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