The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)
Stopped early · Not applicable · Has a placebo group
Conditions studied: Coronary Artery Disease
In brief
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
Key facts
- Study ID
- NCT01078272
- Run by
- St. Francis Hospital, New York
- People needed
- 4
- Starts
- 2010-03-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2020-03-19
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with stable chronic coronary artery disease scheduled for elective percutaneous intervention.
You may not qualify if…
- 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.
Where it is running
- St. Francis Hospital-The Heart Center — Roslyn, New York, United States
Full record on ClinicalTrials.gov
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