The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Other: Remote ischemic preconditioning; Other: Sham Remote Ischemic Preconditioning

• Registration Number: NCT01078272
• Lead Sponsor: St. Francis Hospital, New York

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Preconditioning (RIPC)	Remote ischemic preconditioning	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.
Sham Remote Ischemic Preconditioning	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.

Primary Outcome Measures

Name	Time	Method
MACE	6 months post-stenting	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Francis Hospital-The Heart Center; 🇺🇸 Roslyn, New York, United States