FindTrial
Sign In

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02723851
Enrollment
76
Registered
2016-03-31
Start date
2016-03-31
Completion date
2017-06-30
Last updated
2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

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

Interventions

DEVICECorsens

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.

Sponsors

Corsens Medical LTD
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 to verify safety1 dayTo verify the safety of the Corsens technology while use for myocardial infarction detection.

Secondary

MeasureTime 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.12 months

Contacts

Primary ContactHanna Levy, Dr.
hanna@qsitemed.com+972-52-2824966

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026