The Saint Francis Remote Ischemic Preconditioning Trial (SaFR) (SaFR)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01078272 |
Recruitment Status
: Unknown
Verified February 2010 by St. Francis Hospital, New York.
Recruitment status was: Not yet recruiting
First Posted
: March 2, 2010
Last Update Posted
: March 2, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
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.
|
- 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
- troponin I [ Time Frame: 24 hours ]prevalence of cTn I > 0.12 nG/ml in active RIPC and placebo groups
- chest pain during stenting [ Time Frame: immediate during procedure ]compare frequency, severity(1-10 scale) and duration of chest pain during stent implantation
- 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
- MRI delayed enhancement [ Time Frame: 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 [ Time Frame: 6 months ]Compare left ventricular ejection fraction, end-diastolic and end-systolic volumes between active and placebo groups at 6 months

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, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078272
Contact: Elizabeth Haag, RN CCRP | 5165626790 | Elizabeth.Haag@chsli.org | |
Contact: Lyn Santiago, RN CCRC | 5165626763 | Lyn.Santiago@chsli.org |
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 |
Principal Investigator: | Nathaniel Reichek, MD | St. Francis Hospital-The Heart Center, Roslyn, NY |
Additional Information:
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 Key Record Dates |
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 |