The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

Status: Terminated
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients with stable chronic coronary artery disease scheduled for elective percutaneous intervention.

Locations
United States
New York
St. Francis Hospital-The Heart Center
Roslyn
Time Frame
Start Date: 2010-03
Completion Date: 2011-10
Participants
Target number of participants: 4
Treatments
Experimental: Remote Ischemic Preconditioning (RIPC)
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.
Placebo_comparator: Sham Remote Ischemic Preconditioning
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.
Authors
Nathaniel Reichek, Richard Shlofmitz, Jie (Jane) Cao
Sponsors
Leads: St. Francis Hospital, New York

This content was sourced from clinicaltrials.gov