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The Saint Francis Remote Ischemic Preconditioning Trial (SaFR) (SaFR)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by St. Francis Hospital, New York.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
St. Francis Hospital, New York
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
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Saint Francis Remote Ischemic Preconditioning Trial (SaFR) |
Further study details as provided by St. Francis Hospital, New York:
Primary Outcome Measures:
- 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:
- 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
| 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 (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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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
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:
| 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 |
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 |
ClinicalTrials.gov processed this record on July 25, 2017