NCT01078272

The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: St. Francis Hospital, New York · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	Remote 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.
OTHER	Sham Remote Ischemic Preconditioning	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.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-03-02
• Last updated: 2020-03-19

Locations

1 site across 1 country: United States