The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by St. Francis Hospital, New York.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
St. Francis Hospital, New York
ClinicalTrials.gov Identifier:
NCT01078272
First received: March 1, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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 Intervention
Coronary Artery Disease
Other: Remote ischemic preconditioning
Other: Sham Remote Ischemic Preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

Resource links provided by NLM:


Further study details as provided by St. Francis Hospital, New York:

Primary Outcome Measures:
  • MACE [ Time Frame: 6 months post-stenting ] [ Designated as safety issue: Yes ]
    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:
  • troponin I [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    prevalence of cTn I > 0.12 nG/ml in active RIPC and placebo groups

  • chest pain during stenting [ Time Frame: immediate during procedure ] [ Designated as safety issue: No ]
    compare frequency, severity(1-10 scale) and duration of chest pain during stent implantation

  • ST segment changes during stent implantation [ Time Frame: immediate ] [ Designated as safety issue: No ]
    compare prevalence and severity of electrocardiographic ST segment elevation or depression during stent implantation between active and placebo groups

  • MRI delayed enhancement [ Time Frame: 1-7 days after stenting ] [ Designated as safety issue: Yes ]
    Compare prevalence and volume of myocardial delayed gadolinium enhancement in active and placebo groups

  • Late left ventricular volumes and ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Compare left ventricular ejection fraction, end-diastolic and end-systolic volumes between active and placebo groups at 6 months


Estimated Enrollment: 500
Study Start Date: March 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078272

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

Additional Information:
No publications provided

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
Study First Received: March 1, 2010
Last Updated: March 1, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014