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

NCT02723851 | Unknown

• 1 other identifier: CS-COP-1
• Study Type: observational
• Target: 76
• Locations: 0 countries
• Sites: N/A

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

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (1)

• 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

Study Arms (2)

Acute MI patients

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

Device: Corsens

Non-MI patients

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

Device: Corsens

Interventions

Corsens 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.

Acute MI patients; Non-MI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corsens Medical LTD: lead

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Eugenia Nikolsky, Prof.

  Rambam Medical Center, Haifa Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Levy, Dr.

CONTACT

+972-52-2824966; hanna@qsitemed.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 31, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 31, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share