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

March 29, 2016 updated by: Corsens Medical LTD

An Open Label Study for Determining the Optimal Cut-off Point of Peak Endocardial Acceleration Measured by Corsens Device for Discriminating Between MI and Non-MI Subjects

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with ST-elevation acute MI will be recruited to the study. Additional data that was already recorded in previous study from non-MI patients hospitalized for routine elective catheterization will be used.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute MI patients
Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT).
Device: 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.
Non-MI patients
Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT).
Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corsens Medical LTD

Investigators

  • Principal Investigator: Eugenia Nikolsky, Prof., Rambam Medical Center, Haifa Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-COP-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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