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To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.
Sample size: 45 subjects
Site Locations: Sheba medical center
Patients: Patients presenting with an acute MI with onset of symptoms ï‚£ 6h, and planned to undergo primary PCI will be included. The target lesion should be located in the proximal or middle segment of a main native coronary artery, and should be suitable for percutaneous intervention.
Primary Objective: To determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary PCI and direct stenting in acute MI, and to compared to primary PCI and direct stenting without the postconditioning.
Primary Endpoint:
Secondary endpoints:
Methods:
Follow-up:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postconditioning | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| ST segment resolution. | ||
| Segmental wall motion score, resolution of edema and wall thickness by echocardiography. | ||
| Infarct size estimation by cardiac enzymes and cardiac MRI. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor Guetta, MD | Contact | 972-52-6667127 | victor.Guetta@health.sheba.gov.il | |
| Elad Maor, MD | Contact | 972-52-3691613 | elad.maor@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Victor Guetta, MD | Sheba Medical Center | Principal Investigator |
| Jonathan Leor, MD | Neufeld Cardiac Research Center | Principal Investigator |
| Elad Maor, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Tel Litwinsky | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16186417 | Background | Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26. | |
| 12860564 | Background | Zhao ZQ, Corvera JS, Halkos ME, Kerendi F, Wang NP, Guyton RA, Vinten-Johansen J. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H579-88. doi: 10.1152/ajpheart.01064.2002. |
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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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| ID | Term |
|---|---|
| D057775 | Ischemic Postconditioning |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Neufeld Cardiac Research Center |
| Principal Investigator |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |