The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

St. Francis Hospital, New York

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Other: Sham Remote Ischemic Preconditioning; Other: Remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01078272

09-25

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 2 patient groups, including a placebo group

Remote Ischemic Preconditioning (RIPC)

Experimental group

Description:

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.

Treatment:

Other: Remote ischemic preconditioning

Sham Remote Ischemic Preconditioning

Placebo Comparator group

Description:

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.

Treatment:

Other: Sham Remote Ischemic Preconditioning