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Trial record 4 of 8 for:    cardioflux

Acute Coronary Syndrome CardioFlux TM Study (ACCMED)

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ClinicalTrials.gov Identifier: NCT04739267
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Genetesis Inc.

Tracking Information
First Submitted Date January 27, 2021
First Posted Date February 4, 2021
Last Update Posted Date February 4, 2021
Actual Study Start Date January 27, 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2021)
  • Specificity statistics [ Time Frame: 6 months ]
    analyzing the specificity of CardioFlux
  • Accuracy Statistics [ Time Frame: 6 months ]
    analyzing the accuracy of CardioFlux
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Coronary Syndrome CardioFlux TM Study
Official Title The Acute Coronary Syndrome Accelerated CardioFlux TM Magnetocardiography-based Early Disposition Study
Brief Summary To compare sensitivity and specificity of a CardioFlux based diagnostic algorithm versus standard of care assessment of potential acute coronary syndrome patients.
Detailed Description

To measure the test performance characteristics of the CardioFluxTM magnetocardiography diagnostic system in the early rule in/rule out detection of clinically significant myocardial ischemia in chest pain patients with a modified Heart Score (mHS)>2 on admission (without STEMI) to the emergency department to allow safe and timely disposition of the patient to an appropriate level of care. The study utilizes a "virtual" allocation to an MCG based care pathway to be compared to the standard of care pathway and outcomes.

All patients presenting to the emergency department with possible acute coronary syndrome with a modified heart score (mHS) >2 who are hemodynamically stable and without an ST elevation (STEMI) on admission ECG will be eligible for study inclusion. Patients will undergo an initial ECG, troponin blood draw, and MCG. All patients will be treated using standard of care (SOC) protocols without use of MCG results.

Patients will be allocated to the following virtual study "MCG pathways" by a blinded reviewer based upon the MCG test results: 1) non ischemic- Early Discharge (or considered eligible for evaluation of non-cardiac cause of symptoms); 2) Observation for evaluation of unstable angina without evidence of acute ischemia; or 3) ischemic- Early Cardiology Consult with directed evaluation/treatment.

The outcome measures will be NPV, PPV, sensitivity, specificity for CardioFlux magnetocardiography against ECG and/or troponin-based identification of cardiac ischemia/injury (ie STEMI or NSTEMI diagnosed by SOC pathway prior to discharge or coronary angiography). For the purposes of assessing true comparability, standard of care patients with indeterminate findings leading to observation care will be considered as false positive studies. Performance statistics (when data available) for cardiac catherization requiring revascularization (interventional or surgical) and 30-day MACE (if discharged by SOC) will be calculated for the Ischemic MCG group. The MCG Pathway patients will be compared to SOC for ED/CDU/OBS LOS and hospital charges.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients presenting to the ED with symptoms of potential ACS and fitting the eligibility/exclusion criteria will be approached for accrual
Condition Acute Myocardial Injuries
Intervention Other: Not an intervention
Not an intervention
Study Groups/Cohorts Not Provided
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 Recruiting
Estimated Enrollment
 (submitted: February 1, 2021)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. ≥ 18 years of age at the time of enrollment.
  2. Patient presenting with symptoms and signs consistent with ACS who do not have evidence of STEMI and/or hemodynamic instability on admission.
  3. Consents to having an MCG-CF study scan.
  4. Modified HEART score of 3-7

Exclusion Criteria:

  1. < 18 years of age
  2. Patients unable to fit into device
  3. Non-ambulatory patients
  4. Positive response on MCG Pre-Screening Form
  5. AF with RVR >120 bpm and/or hemodynamic instability
  6. Patients with claustrophobia or unable to lie supine for up to 5 minutes
  7. Pregnant women
  8. Poor candidate for follow-up (e.g. no access to phone)
  9. Prisoners
  10. Repeat participants
  11. STEMI
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Anthony Senagore, M.D. 513-715-5045 anthony@genetesis.com
Contact: Samantha Legreaux, M.S. 513-715-5045 sam.legreaux@genetesis.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04739267
Other Study ID Numbers 1000-2
Has Data Monitoring Committee No
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
Responsible Party Genetesis Inc.
Study Sponsor Genetesis Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Anthony Senagore, M.D. Genetesis Inc.
PRS Account Genetesis Inc.
Verification Date February 2021