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Use of Magnetocardiography in Evaluation of Patients Going for Cardiac Catheterization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04044391
Recruitment Status : Terminated (Study was defunded.)
First Posted : August 5, 2019
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Genetesis Inc.

Tracking Information
First Submitted Date August 1, 2019
First Posted Date August 5, 2019
Last Update Posted Date May 26, 2020
Actual Study Start Date May 15, 2019
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 6, 2019)
  • 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) .
  • 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.
Original Primary Outcome Measures
 (submitted: August 1, 2019)
  • Accuracy of MCG to detect myocardial ischemia as determined by cardiac catheterization [ Time Frame: 72 hours ]
    Assess accuracy of CardioFlux MCG 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) .
  • 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.
Change History
Current Secondary Outcome Measures
 (submitted: August 1, 2019)
  • 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.
  • Inter-reader reliability percentage [ Time Frame: 6 months ]
    Measurement of consistency of interpretation among 3 physician readers of CardioFlux MCG scans.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Acute Coronary Syndrome
  • Coronary Artery Stenosis
  • Myocardial Ischemia
Intervention 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.
Study Groups/Cohorts
  • 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.
    Intervention: Diagnostic Test: CardioFlux Magnetocardiograph
  • 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).
    Intervention: Diagnostic Test: CardioFlux Magnetocardiograph
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 21, 2020)
101
Original Estimated Enrollment
 (submitted: August 1, 2019)
1500
Actual Study Completion Date May 4, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04044391
Other Study ID Numbers 1345773
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
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.
Responsible Party Genetesis Inc.
Study Sponsor Genetesis Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Claire Pearson, M.D. Ascension St, John Medical Center
PRS Account Genetesis Inc.
Verification Date May 2020