The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

NCT01078272 | Terminated

• 1 other identifier: 09-25
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• troponin I

  24 hours

• chest pain during stenting

  immediate during procedure

• ST segment changes during stent implantation

  immediate

• MRI delayed enhancement

  1-7 days after stenting

• Late left ventricular volumes and ejection fraction

  6 months

Study Arms (2)

Remote Ischemic Preconditioning (RIPC)

EXPERIMENTAL

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

Sham Remote Ischemic Preconditioning

PLACEBO COMPARATOR

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

Interventions

Remote ischemic preconditioning OTHER

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.

Remote Ischemic Preconditioning (RIPC)

Sham Remote Ischemic Preconditioning OTHER

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.

Sham Remote Ischemic Preconditioning

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable chronic coronary artery disease scheduled for elective percutaneous intervention.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Francis Hospital, New York: lead

Study Sites (1)

St. Francis Hospital-The Heart Center

Roslyn, New York, 11576, United States

Location

Related Links

• First randomized trial of RIPC for coronary stenting
• editorial review of remote ischemic preconditioning in coronary disease

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Nathaniel Reichek, MD

  St. Francis Hospital-The Heart Center, Roslyn, NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Research Department and Cardiac Imaging Program

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

US (1)