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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 : September 16, 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 September 16, 2021
Actual Study Start Date January 27, 2021
Estimated Primary Completion Date July 2022   (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
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 Approximately 16.5 million people suffer from coronary artery disease (CAD) and about 10 million present each year to emergency departments with symptoms like chest pain and shortness of breath, commonly suggestive of acute coronary syndrome (ACS). To clinically assess ACS risk in these patients, there are typically 2-6 hours of emergency room evaluation, followed by 6-42 hours of an observation period prior to discharge. The clinical pathway includes: 1) 1-3 ECG's; 2) serial troponins (1 and 3 hours vs 1 and 6 hours); and 3) other pertinent diagnostic information, including but not limited to echocardiography, stress testing and/or CT Angiography. Patients who are evaluated, have presented with a low risk for ACS, and maintain negative diagnostic results can potentially be discharged within 6 hours. However, 20%-40% of patients who fall into indeterminate diagnostic categories will require longer observation periods or admission of 12-48 hours which result in the use of expensive imaging and provocative testing, such as stress testing. The purpose of ACCMED is to measure the efficacy and diagnostic accuracy of CardioFlux as an adjunctive diagnostic tool to rule-in/rule-out ACS in patients with symptoms suggestive of ACS, and evaluate the clinical and economic advantages of incorporating MCG into the triage pathway.
Detailed Description Not Provided
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 Device: CardioFlux
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 2022
Estimated Primary Completion Date July 2022   (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 September 2021