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

• Conditions: Myocardial Infarction
• Interventions: Device: Corsens

• Registration Number: NCT02723851
• Lead Sponsor: Corsens Medical LTD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-29
• Last Update Submitted: 2016-03-29
• Study First Posted: 2016-03-31
• Last Update Posted: 2016-03-31
• Primary Completion: 2017-03
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-MI patients	Corsens	Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index \[MCI\] and isovolumetric contraction (IVCT).
Acute MI patients	Corsens	Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index \[MCI\] and isovolumetric contraction (IVCT).

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" to verify safety	1 day	To verify the safety of the Corsens technology while use for myocardial infarction detection.

Secondary Outcome Measures

Name	Time	Method
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.	12 months