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Use of Magnetocardiography in Evaluation of Patients Going for Cardiac Catheterization

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ClinicalTrials.gov Identifier: NCT04044391
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Genetesis Inc.

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.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Coronary Artery Stenosis Myocardial Ischemia Diagnostic Test: CardioFlux Magnetocardiograph

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.


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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Magnetocardiography Using the CardioFlux (TM) System in the Evaluation of Acute Coronary Syndrome Patients Going for Cardiac Catheterization
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Intention to Treat: Cardiac Catheterization
All patients meeting inclusion criteria and scheduled to undergo cardiac catheterization will undergo a CardioFlux magnetocardiogram (MCG) to determine presence of patterns which indicate myocardial ischemia.
Diagnostic Test: CardioFlux Magnetocardiograph
CardioFlux is a noninvasive diagnostic modality which can measure and image the heart's intrinsic magnetic field created by ion transit across cardiac cell membranes.

Post Percutaneous Coronary Intervention
All patients found to have significant coronary artery obstruction seen via angiography +/- fractional flow reserve (FFR) or instant wave-free ratio (iFR) and who receive a catheter based intervention will have a post-procedure CardioFlux MCG scan. Follow up over the next 30 and 180 days will be performed to determine if a persistent pattern suggesting residual ischemia will correlate with an increased incidence of major cardiac adverse events (MACE).
Diagnostic Test: CardioFlux Magnetocardiograph
CardioFlux is a noninvasive diagnostic modality which can measure and image the heart's intrinsic magnetic field created by ion transit across cardiac cell membranes.




Primary Outcome Measures :
  1. Accuracy of MCG to detect myocardial ischemia as determined by cardiac catheterization [ Time Frame: 72 hours ]
    Assess accuracy of CardioFlux MCG (MCG-CF) and magnetic field map characteristics with findings of significant coronary artery stenosis ≥70% via angiography and/or via FFR of <0.8 or via instant wave-free ratio (iFR) .

  2. Accuracy of MCG vs. ECG [ Time Frame: 72 hours ]
    Compare CardioFlux MCG accuracy to ECG accuracy in identifying cardiac ischemia using coronary angiography with or without FFR/iFR as gold standard.


Secondary Outcome Measures :
  1. Incident of post-PCI MACE [ Time Frame: 6 months ]
    Determine if residual abnormalities on post PCI MCG-CF maps can predict 30 day and 180 day MACE.

  2. Inter-reader reliability percentage [ Time Frame: 6 months ]
    Measurement of consistency of interpretation among 3 physician readers of CardioFlux MCG scans.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044391


Contacts
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Contact: Claire Pearson, M.D. 313-343-3400 cpearson@wayne.med.edu
Contact: Viviane Kazan, M.D. 313-343-3562 viviane.kazan@ascension.org

Locations
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United States, Michigan
Ascension St. John Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Claire Pearson, M.D.    313-343-3400    cpearson@med.wayne.edu   
Contact: Viviane Kazan, M.D.    313-343-3562    viviane.kazan@ascension.org   
Principal Investigator: Edouard Daher, M.D.         
Sponsors and Collaborators
Genetesis Inc.
Investigators
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Principal Investigator: Claire Pearson, M.D. Ascension St, John Medical Center

Publications:
Chen T, Z., C., Jiang, S, Van Leeuwen, P., Gronemeyer, D, Noninvasively diagnosing coronary artery disease with 61 channel MCG data. Chinese Science Bulletin. , 2014. 59: p. 1123.

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Responsible Party: Genetesis Inc.
ClinicalTrials.gov Identifier: NCT04044391     History of Changes
Other Study ID Numbers: 1345773
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual patient data (IPD) available to researchers not affiliated with the centers enrolling patients within this trial.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Genetesis Inc.:
Coronary Artery Disease
Myocardial ischemia
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Coronary Artery Disease
Coronary Stenosis
Syndrome
Ischemia
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases