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

Creavo Medical Technologies Ltd651 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

651

Conditions

Acute Coronary Syndrome

Interventions

VitalScan MagnetocardiographDEVICE

A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Sensitivity and specificity of MCG

Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm

Time frame: up to 3 month follow-up

Secondary Outcomes

Proportion of adverse events and types

Time frame: up to 3 month follow-up

All-cause mortatility (divided into CV and non-CV causes) proportion

Time frame: through 1 week, 3 month follow-up

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

Time frame: 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))

Time frame: through 1 week, 3 month follow-up

Data from ClinicalTrials.gov

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