VitalScan MCG Rule-out Multi-centre Pivotal Study - US
Terminated
- Conditions
- Acute Coronary Syndrome
- Interventions
- Device: VitalScan Magnetocardiograph
- Registration Number
- NCT03546933
- Lead Sponsor
- Creavo Medical Technologies Ltd
- Brief Summary
A prospective multi-centre observational study to validate the diagnostic accuracy of a transportable magnetocardiograph device for acute coronary syndrome (ACS), focusing on rule-out capability, in patients who present to the emergency department with chest pain symptoms consistent with ACS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 651
Inclusion Criteria
- Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS)
- 18+ year old male or female
- Patient is willing and able to give written informed consent
Exclusion Criteria
- ST-segment Elevation MI (STEMI)
- Clear non-ischemic cause for symptoms (e.g. trauma)
- Hemodynamic instability on admission (e.g. BP>220mmHg systolic & >110mmHg diastolic, <80mmHg systolic & <40mmHg diastolic, HR>160bpm)
- Ventricular tachycardia or fibrillation that cannot be treated effectively
- Atrial fibrillation
- Thoracic metal implants
- Pacemaker or internal defibrillator
- Pregnancy (if after 20-week period)* or lactation
- Patient unable to lie down (i.e. supine position) or stay still on the examination bed
- Patient unable to understand the informed consent process and/or has a poor understanding of English (e.g. English- speaking relative/translator not available)
- Patient unable to comply with the requirements of the protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chest pain patients presenting to the ED VitalScan Magnetocardiograph All patients that present to the emergency department with chest pain and potentially other symptoms consistent with ACS and meet all eligibility criteria will undergo VitalScan Magnetocardiograph.
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of MCG up to 3 month follow-up Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm
- Secondary Outcome Measures
Name Time Method 3.Change in sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm, according to low, intermediate and high PTP groups up to 3 months follow-up MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard (adjudicated ACS/non-ACS diagnoses)) through 1 week, 3 month follow-up Proportion of adverse events and types up to 3 month follow-up All-cause mortatility (divided into CV and non-CV causes) proportion through 1 week, 3 month follow-up
Trial Locations
- Locations (5)
IU Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States