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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute MI patients | Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT). |
| |
| Non-MI patients | Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Levy, Dr. | Contact | +972-52-2824966 | hanna@qsitemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Eugenia Nikolsky, Prof. | Rambam Medical Center, Haifa Israel | Principal Investigator |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |