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The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

NCT01078272 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-03-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • St. Francis Hospital, New York

    lead OTHER

Principal Investigators

  • Nathaniel Reichek, MD · St. Francis Hospital-The Heart Center, Roslyn, NY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01078272 on ClinicalTrials.gov