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poor enrollment
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Remote ischemic preconditioning is a process of serial blood pressure cuff inflations and deflations that are performed prior to a procedure and have been shown in various other areas (coronary bypass surgery, vascular surgery, ST elevation myocardial infarctions) to decrease the rates of adverse events related to ischemic burden and renal injury. This procedure has not yet been studied in the population presenting with an acute coronary syndrome (ACS), even though ACS patients represent the majority of patients seen in the catheterization lab. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in this particular population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This group will undergo remote ischemic preconditioning with serial inflations of the blood pressure cuff to 200 mmHg followed by deflation for reperfusion for a period of 5 minutes each for a total of 4 cycles. |
|
| Control | Sham Comparator | This group will undergo serial inflations of the blood pressure cuff to 40 mmHg followed by deflation for a period of 5 minutes each for a total of 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischemic Preconditioning | Procedure | Serial inflations and deflations as detailed in the arm/group descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic Burden | Assess the impact of remote ischemic preconditioning on myonecrosis following percutaneous coronary intervention by examining pre and post biomarkers | 48-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes | Assess the effects on clinical outcomes at 6 months post initial ACS event including death, MI, stroke, revascularization and hospital readmission. | 6 months |
| Renal Injury | Assess the effects on post procedure renal injury |
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Inclusion Criteria:
- Presenting with an acute coronary syndrome including non-ST elevation myocardial infarction or unstable angina on optimal medical therapy with aspirin, P2Y12 inhibitors, unfractionated heparin, statin, +/- beta blocker, +/- ace inhibitor
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Koenig, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D051437 | Renal Insufficiency |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007674 | Kidney Diseases |
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| 48-72 hours |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |