The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

Study Overview
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Brief Summary
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This study tests the hypothesis that repeated inflation of a blood pressure cuff on the arm will improve results of coronary stent implantation by: reducing chest pain and electrocardiogram changes during balloon inflation to place the stent reducing leakage of heart muscle protein(troponin) into the blood stream after stent placement, indicated reduced damage to heart muscle during stent implantation increases in molecules in the blood that promote dilation of arteries reduced evidence of heart muscle damage on MRI immediately after stenting improved patient outcomes over six months with fewer adverse cardiovascular events(heart attack, acute coronary syndrome,renarrowing of the stented artery, heart failure, death, stroke, transient ischemic attack) improved heart structure and function at 6 months after stenting

Official Title
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The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Remote ischemic preconditioning
* Other: Sham Remote Ischemic Preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stable chronic coronary artery disease scheduled for elective percutaneous intervention. Exclusion Criteria: Recent (1 month) myocardial infarction Acute coronary syndrome Chest pain at res Estimated glomerular filtration rate(GFR)<45 mL/min/1.73 m2 Frequent premature atrial or ventricular contractions or atrial fibrillation Any contraindication to MRI including implanted non MRI compatible medical devices or ferromagnetic materials such as shrapnel Inability to breath-hold Severe claustrophobia Deafness Persistent tremor Inability to follow instructions.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Ischemic Preconditioning (RIPC)<br>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. | Other: Remote ischemic preconditioning<br>* 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.<br>|
| Placebo Comparator: Sham Remote Ischemic Preconditioning<br>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. | Other: Sham Remote Ischemic Preconditioning<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Atherosclerosis, Percutaneous Coronary Intervention, Coronary Stenting, Coronary Stenosis, Remote Ischemic Preconditioning