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
|Condition or disease||Intervention/treatment|
|Acute Myocardial Injuries||Other: Not an intervention|
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|
|Estimated Enrollment :||600 participants|
|Official Title:||The Acute Coronary Syndrome Accelerated CardioFlux TM Magnetocardiography-based Early Disposition Study|
|Actual Study Start Date :||January 27, 2021|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
- Other: Not an intervention
Not an intervention
- Specificity statistics [ Time Frame: 6 months ]analyzing the specificity of CardioFlux
- Accuracy Statistics [ Time Frame: 6 months ]analyzing the accuracy of CardioFlux
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): NCT04739267
|Contact: Anthony Senagore, M.D.||firstname.lastname@example.org|
|Contact: Samantha Legreaux, M.S.||email@example.com|
|United States, Ohio|
|Mason, Ohio, United States, 45040|
|Contact: Sam Legreaux, M.S. 513-715-5045 firstname.lastname@example.org|
|Principal Investigator:||Anthony Senagore, M.D.||Genetesis Inc.|