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

Corsens Medical

Status: Unknown

Conditions: Myocardial Infarction

Treatments: Device: Corsens

Study type: Observational

Funder types: Industry

Identifiers

NCT02723851

CS-COP-1

Details and patient eligibility

About

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

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

76 participants in 2 patient groups

Acute MI patients

Description:

Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index \[MCI\] and isovolumetric contraction (IVCT).

Treatment:

Device: Corsens

Non-MI patients

Description:

Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index \[MCI\] and isovolumetric contraction (IVCT).

Treatment:

Device: Corsens