Not provided
Not provided
Not provided
Not provided
Recruitment inadequate
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study tests the hypothesis that repeated inflation of a blood pressure cuff on the arm will improve results of coronary stent implantation by:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischemic Preconditioning (RIPC) | Experimental | Randomized subjects who are treated immediately prior to stenting with remote ischemic preconditioning consisting of 3 5 minute blood pressure cuff inflations to occlude the brachial artery in their nondominant arms, with intervening 5 minute rest periods. |
|
| Sham Remote Ischemic Preconditioning | Placebo Comparator | Patients who prior to stenting have the RIPC blood pressure cuff placed but not inflated for 3 5 minute episodes with 5 minute rest periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning | Other | Randomized subjects are treated immediately prior to stenting with remote ischemic preconditioning consisting of 3 5 minute blood pressure cuff inflations to occlude the brachial artery in their nondominant arms, with intervening 5 minute rest periods. |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | MACE is defined as a combined endpoint including: heart attack, acute coronary syndrome,restenosis of the stented artery, new heart failure stroke, transient ischemic attack or death | 6 months post-stenting |
| Measure | Description | Time Frame |
|---|---|---|
| troponin I | prevalence of cTn I > 0.12 nG/ml in active RIPC and placebo groups | 24 hours |
| chest pain during stenting | compare frequency, severity(1-10 scale) and duration of chest pain during stent implantation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Reichek, MD | St. Francis Hospital-The Heart Center, Roslyn, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Francis Hospital-The Heart Center | Roslyn | New York | 11576 | United States |
Not provided
| Label | URL |
|---|---|
| First randomized trial of RIPC for coronary stenting | View source |
| editorial review of remote ischemic preconditioning in coronary disease | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham Remote Ischemic Preconditioning | Other | Randomized subjects who are exposed immediately prior to stenting to sham remote ischemic preconditioning consisting of 3 5 minute blood pressure cuff placements without inflation on their nondominant arms, with intervening 5 minute rest periods. |
|
| immediate during procedure |
| ST segment changes during stent implantation | compare prevalence and severity of electrocardiographic ST segment elevation or depression during stent implantation between active and placebo groups | immediate |
| MRI delayed enhancement | Compare prevalence and volume of myocardial delayed gadolinium enhancement in active and placebo groups | 1-7 days after stenting |
| Late left ventricular volumes and ejection fraction | Compare left ventricular ejection fraction, end-diastolic and end-systolic volumes between active and placebo groups at 6 months | 6 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |