The Saint Francis Remote Ischemic Preconditioning Trial (SaFR) (SaFR)

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

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Remote ischemic preconditioning; Other: Sham Remote Ischemic Preconditioning

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital-The Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	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	6 months post-stenting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
troponin I	prevalence of cTn I > 0.12 nG/ml in active RIPC and placebo groups	24 hours
chest pain during stenting	compare frequency, severity(1-10 scale) and duration of chest pain during stent implantation	immediate during procedure
ST segment changes during stent implantation	compare prevalence and severity of electrocardiographic ST segment elevation or depression during stent implantation between active and placebo groups	immediate
MRI delayed enhancement	Compare prevalence and volume of myocardial delayed gadolinium enhancement in active and placebo groups	1-7 days after stenting
Late left ventricular volumes and ejection fraction	Compare left ventricular ejection fraction, end-diastolic and end-systolic volumes between active and placebo groups at 6 months	6 months

Collaborators and Investigators

• Sponsor: St. Francis Hospital, New York
• Investigators: Principal Investigator: Nathaniel Reichek, MD, St. Francis Hospital-The Heart Center, Roslyn, NY

Publications and helpful links

Helpful Links

• First randomized trial of RIPC for coronary stenting
• editorial review of remote ischemic preconditioning in coronary disease
• Lancet, trial of RIPC in acute myocardial infarction

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (Estimate): March 2, 2010

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Coronary Stenosis; Coronary Atherosclerosis; Remote Ischemic Preconditioning; Coronary Stenting
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 09-25