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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Other: Remote ischemic preconditioning; Other: Sham Remote Ischemic Preconditioning	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	500 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)
Study Start Date :	March 2010
Estimated Primary Completion Date :	September 2011
Estimated Study Completion Date :	September 2011

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. MACE [ Time Frame: 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 :

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

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Elizabeth Haag, RN CCRP	5165626790	Elizabeth.Haag@chsli.org
Contact: Lyn Santiago, RN CCRC	5165626763	Lyn.Santiago@chsli.org

Locations

United States, New York
St. Francis Hospital-The Heart Center	Not yet recruiting
Roslyn, New York, United States, 11576
Principal Investigator: Nathaniel Reichek, MD
Sub-Investigator: Richard Shlofmitz, MD
Sub-Investigator: Jie (Jane) Cao, MD, MPH
Sub-Investigator: Madhavi Kadiyala, MD

Sponsors and Collaborators

St. Francis Hospital, New York

Investigators

Principal Investigator:	Nathaniel Reichek, MD	St. Francis Hospital-The Heart Center, Roslyn, NY

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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 

Responsible Party:	Nathaniel Reichek MD, FACC, FAHA Director, Research Department, Director, Cardiac Imaging, St. Francis Hospital, St. Francis Hospital-The Heart Center, Roslyn, NY
ClinicalTrials.gov Identifier:	NCT01078272 History of Changes
Other Study ID Numbers:	09-25
First Posted:	March 2, 2010
Last Update Posted:	March 2, 2010
Last Verified:	February 2010

Keywords provided by St. Francis Hospital, New York:

Coronary Atherosclerosis; Percutaneous Coronary Intervention; Coronary Stenting; Coronary Stenosis; Remote Ischemic Preconditioning

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases	Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases