The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

Coronary Artery Disease Clinical Trial

— SaFR  

Official title:

The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01078272
• Other study ID #: 09-25
• Status: Terminated
• Phase: N/A
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2020
• Source: St. Francis Hospital, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St. Francis Hospital-The Heart Center	Roslyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Francis Hospital, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	troponin I	prevalence of cTn I > 0.12 nG/ml in active RIPC and placebo groups	24 hours
Secondary	chest pain during stenting	compare frequency, severity(1-10 scale) and duration of chest pain during stent implantation	immediate during procedure
Secondary	ST segment changes during stent implantation	compare prevalence and severity of electrocardiographic ST segment elevation or depression during stent implantation between active and placebo groups	immediate
Secondary	MRI delayed enhancement	Compare prevalence and volume of myocardial delayed gadolinium enhancement in active and placebo groups	1-7 days after stenting
Secondary	Late left ventricular volumes and ejection fraction	Compare left ventricular ejection fraction, end-diastolic and end-systolic volumes between active and placebo groups at 6 months	6 months

External Links

•   editorial review of remote ischemic preconditioning in coronary disease
•   First randomized trial of RIPC for coronary stenting
•   Lancet, trial of RIPC in acute myocardial infarction