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

NCT ID: NCT02723851

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute MI patients

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

Corsens

Intervention Type DEVICE

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.

Non-MI patients

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

Corsens

Intervention Type DEVICE

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.

Interventions

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Corsens

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corsens Medical LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugenia Nikolsky, Prof.

Role: PRINCIPAL_INVESTIGATOR

Rambam Medical Center, Haifa Israel

Central Contacts

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Hanna Levy, Dr.

Role: CONTACT

Phone: +972-52-2824966

Email: [email protected]

Other Identifiers

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CS-COP-1

Identifier Type: -

Identifier Source: org_study_id