The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

St. Francis Hospital, New York4 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Sham Remote Ischemic PreconditioningOTHER

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 6 months post-stenting

Secondary Outcomes

troponin I

prevalence of cTn I \> 0.12 nG/ml in active RIPC and placebo groups

Time frame: 24 hours

chest pain during stenting

compare frequency, severity(1-10 scale) and duration of chest pain during stent implantation

Time frame: 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

Time frame: immediate

MRI delayed enhancement

Compare prevalence and volume of myocardial delayed gadolinium enhancement in active and placebo groups

Time frame: 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

Time frame: 6 months