VitalScan MCG Rule-out Multi-centre Pivotal Study - US



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:July 17, 2018
End Date:October 2019
Contact:Hannah R Vester, BS
Email:vesterhr@ucmail.uc.edu
Phone:513-558-6028

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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

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.


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
We found this trial at
4
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Ryan Walsh, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: W. Frank Peacock, MD
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Richard Ryan, MD
Phone: 513-227-5490
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Winston-Salem, North Carolina 27157
Principal Investigator: Simon Mahler, MD
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Winston-Salem, NC
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