MCG as a Noninvasive Diagnostic Strategy for Suspected INOCA (MICRO2)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 24-002102
NCT ID: NCT06212466
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion 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:
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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 5/28/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Abhiram Prasad, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available