Coronary Artery Disease
Conditions
Keywords
Coronary Atherosclerosis, Percutaneous Coronary Intervention, Coronary Stenting, Coronary Stenosis, Remote Ischemic Preconditioning
Brief summary
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
Interventions
OTHERRemote ischemic preconditioning
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.
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.
Sponsors
St. Francis Hospital, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 6 months post-stenting | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| troponin I | 24 hours | prevalence of cTn I \> 0.12 nG/ml in active RIPC and placebo groups |
| chest pain during stenting | immediate during procedure | compare frequency, severity(1-10 scale) and duration of chest pain during stent implantation |
| ST segment changes during stent implantation | immediate | compare prevalence and severity of electrocardiographic ST segment elevation or depression during stent implantation between active and placebo groups |
| MRI delayed enhancement | 1-7 days after stenting | Compare prevalence and volume of myocardial delayed gadolinium enhancement in active and placebo groups |
| Late left ventricular volumes and ejection fraction | 6 months | Compare left ventricular ejection fraction, end-diastolic and end-systolic volumes between active and placebo groups at 6 months |
Countries
United States
Outcome results
None listed