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

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ClinicalTrials.gov Identifier: NCT02723851
Recruitment Status : Unknown
Verified March 2016 by Corsens Medical LTD.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Corsens Medical LTD

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


Condition or disease Intervention/treatment
Myocardial Infarction Device: Corsens

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Study Type : Observational
Estimated Enrollment : 76 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723851


Contacts
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Contact: Hanna Levy, Dr. +972-52-2824966 hanna@qsitemed.com

Sponsors and Collaborators
Corsens Medical LTD
Investigators
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Principal Investigator: Eugenia Nikolsky, Prof. Rambam Medical Center, Haifa Israel

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Responsible Party: Corsens Medical LTD
ClinicalTrials.gov Identifier: NCT02723851     History of Changes
Other Study ID Numbers: CS-COP-1
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases