Determining the Optimal Cut-off Point of PEA by Corsens Device for Discriminating Between MI and Non-MI Subjects

Corsens Medical LTD76 enrolled

Overview

Acute Myocardial Infarction (MI) is still the leading cause of death in the western world. Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In average it takes between 2-3 hours from the beginning of the chest pain. The damage to the heart in these 2 hours is critical and often irreversible. Thus an early warning test or device is highly warranted. Corsens has developed a noninvasive device using several sensors applied to the chest and a detection system able to recognize the ischemic origin of chest pain. This clinical study is intended for evaluating the safety and efficacy of the Corsens technology while use for myocardial infarction detection

Study Type

OBSERVATIONAL

Enrollment

Conditions

Myocardial Infarction

Interventions

CorsensDEVICE

Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index \[MCI\] and isovolumetric contraction (IVCT). Measurements will not affect the treatment provided to the patients.

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Patients admitted to the cardiac care unit (CCU) with ST elevation acute MI (STEMI) within 4 hours from beginning of chest pain. * Male or female subjects aged 18 years or more (with no upper limit), of any race. * Subjects willing to participate as evidenced by signing the written informed consent. Exclusion Criteria: * Obese patients with BMI\>35. * Subjects with cardiac arrhythmias including atrial fibrillation. Previous MI. * Patients after coronary artery bypass grafting * Unstable hemodynamic condition. * Patient that can't or do not wish to sign the Inform Consent Form

Outcomes

Primary Outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" to verify safety

To verify the safety of the Corsens technology while use for myocardial infarction detection.

Time frame: 1 day

Secondary Outcomes

To define the optimal cut-off point (in terms of sensitivity and specificity) of the PEA measured by Corsens technology for discriminating between MI and non-MI patient.

Time frame: 12 months