Clinical trial NCT04044391: Use of Magnetocardiography in Evaluation of Patients Going for Cardiac Catheterization
Official title: Noninvasive Magnetocardiography Using the CardioFlux (TM) System in the Evaluation of Acute Coronary Syndrome Patients Going for Cardiac Catheterization
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Coronary Syndrome
Coronary Artery Stenosis
Myocardial Ischemia
Keywords: Coronary Artery Disease
Myocardial ischemia
Lead sponsor: Genetesis Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-05
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This research study will enroll patients who will undergo cardiac catheterization because of symptoms and risk factors suggestive of acute coronary syndrome, and high risk patients presenting for cardiac catheterization due to an abnormal stress test. Patients meeting these criteria, and over the age of 18 years and all genders will be candidates.

Brief summary: This is a multicenter, prospective trial to measure the test performance characteristics of the Magnetocardiography (MCG) CardioFlux cardiac diagnostic system in detecting clinically significant coronary artery obstruction in patients with symptoms of suspected acute coronary syndrome or who present with a failed stress test with the intention of treat with cardiac catheterization.

Detailed description: This is a multicenter, prospective clinical trial studying the utility and accuracy of magnetocardiography (MCG) in identifying critical coronary artery obstruction responsible for myocardial ischemia. The study will enroll up to 1500 patients at high risk for coronary artery disease (CAD) who have been referred for cardiac catheterization. These patients will be recruited from an inpatient service post admission for chest pain or anginal equivalent or from a cohort of symptomatic patients who have failed outpatient stress testing. If they meet other stated inclusion criteria, they will have a 2 minute MCG scan prior to their cardiac catheterization. For comparative purposes, the first 300 patients will have an electrocardiogram (ECG) performed within 60 minutes of this initial scan.

After an enrolled study subject has had their catheterization procedure, the results of the catheterization will be reviewed by one of the study's primary investigators. If the subject has had a percutaneous coronary intervention (PCI), a second MCG scan will be performed prior to their discharge. The MCG scans will be interpreted by 3 physicians trained to read these images and blinded to all clinical information regarding study subjects.

The initial MCG scan will be evaluated for its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and overall accuracy in detecting myocardial ischemia and critical coronary stenosis based on angiographic imaging, fractional flow reserve (FFR), or instant wave-free ratio (iFR) measurements, as applicable. The same statistical analysis will be performed for the ECGs performed on each of the applicable study subjects. When performed, the second MCG will be evaluated for any abnormalities after revascularization. These results will be used to determine the value of post-PCI MCG to predict 30 day and 180 day major adverse cardiac events (MACE)-specifically myocardial infarction or stroke, need for revascularization, or cardiac related death.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age at the time of enrollment.
* Patient presenting acutely with signs and symptoms suggestive of Acute Coronary Syndrome (ACS) and in the opinion of the treating physician and based on best clinical assessment that a cardiac catheterization will be performed; or, had a positive stress test and is scheduled for cardiac catheterization.
* Patient's ability to lay supine for five minutes.

Exclusion Criteria:

* Age \< 18 years of age
* Patients unable to fit into device
* Unable to transfer to device gantry
* Positive response on magnetocardiography (MCG) prescreening form
* Patients with claustrophobia or unable to lie supine for five minutes
* Pregnant women
* Poor candidate for follow-up (e.g. no access to phone)
* Repeat participants
* Prisoners
* Acute STEMI or hemodynamically unstable patients (Mean Arterial Pressure ≤ 65, Respiratory Rate ≥24, Heart Rate ≥105 bpm, Temperature\>38.1 or \<34 degrees Celsius, O2 Saturation\<90% despite oxygen therapy).
* Do not resuscitate order (DNR)
* Unable to have a cardiac catheterization secondary to dye, allergy, creatinine clearance, can't obtain access, etc.

Primary outcomes:
measure: Accuracy of MCG to detect myocardial ischemia as determined by cardiac catheterization
timeFrame: 72 hours
measure: Accuracy of MCG vs. ECG
timeFrame: 72 hours
Secondary outcomes:
measure: Incident of post-PCI MACE
timeFrame: 6 months
measure: Inter-reader reliability percentage
timeFrame: 6 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Ascension St. John Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
Study officials:
affiliation: Ascension St, John Medical Center
name: Claire Pearson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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