MCG As A Noninvasive Diagnostic Strategy For Suspected INOCA (MICRO2)

Overview

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:

- ≥ 18 years of age at the time of enrollment

- Signs and symptoms of chest pain that prompted further evaluation by either a heart
angiogram or a scan of the heart (coronary CT angiogram) within the previous 5 years

- Willing to provide written informed consent

- Non-obstructive CAD defined as:

- 0 to 49% diameter reduction of a major epicardial vessel by CT or Angiography

- or a FFR>0.80 or iFR or RFR >0.89

- Completed invasive CFR/angiogram (within 180 days of informed consent)

- Successfully passing CardioFlux MCG Quality Preview prior to MCG study scan

Exclusion Criteria:

- Patients unable to fit into device.

- Patients who meet device contraindications. The MCG signal is not able to be
interpreted in patients with the following: Presence of ferromagnetic metal above the
costal margin of the rib cage; Implanted pacemakers or cardioverter/defibrillators;
Implanted infusion pumps and/or neuro stimulators (NOTE: sternotomy wires and stents
are acceptable)

- Patients unable to lie supine for 5 minutes.

- Prior enrollment in MICRO 1.0 and/or MICRO(T) data development study.

- History of non-ischemic dilated or hypertrophic cardiomyopathy

- Documented acute coronary syndrome (ACS) within previous 30 days

- Known left ventricular ejection fraction (LVEF) <45%, or hospitalization for Reduced
ejection fraction within 180 days. (HFpEF is allowed)

- Currently in atrial fibrillation or atrial flutter at the time of enrollment

- Complete Bundle Branch Block within previous 180 days of enrollment

- Known estimated glomerular filtration rate (eGFR) <30 ml/min.

- Known moderate or severe valvular disease (anything besides mild)

- Life expectancy <3-yrs. due to non-cardiovascular comorbidity

- Concurrent enrollment in a clinical trial in which therapeutic intervention is
administered within 30 days of enrollment.

- Pregnancy

- Dextrocardia

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/22/2024. 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

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Abhiram Prasad, M.D.

Closed for enrollment

More information

Publications

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