Coronary Artery DiseaseSaFRNCT01078272
The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)
A study testing Remote ischemic preconditioning in people with Coronary Artery Disease, run by St. Francis Hospital, New York at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Remote ischemic preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable chronic coronary artery disease scheduled for elective percutaneous intervention.
Who cannot join
- 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
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- Inability to breath-hold
- Severe claustrophobia
- Deafness
- Persistent tremor
- Inability to follow instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Francis Hospital-The Heart Center
Roslyn, New York, 11576
About this study
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
- Being tested
- Remote ischemic preconditioning, Sham Remote Ischemic Preconditioning
- Keywords
- Coronary Atherosclerosis, Percutaneous Coronary Intervention, Coronary Stenting, Coronary Stenosis, Remote Ischemic Preconditioning
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningOther
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 PreconditioningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Remote Ischemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months post-stenting
Secondary outcomes (5)
troponin I
prevalence of cTn I > 0.12 nG/ml in active RIPC and placebo groups
Measured: 24 hours
chest pain during stenting
compare frequency, severity(1-10 scale) and duration of chest pain during stent implantation
Measured: immediate during procedure
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
Measured: immediate
MRI delayed enhancement
Compare prevalence and volume of myocardial delayed gadolinium enhancement in active and placebo groups
Measured: 1-7 days after stenting
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Recruitment inadequate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Francis Hospital, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathaniel Reichek MD, St. Francis Hospital, New York
- Investigators
- Nathaniel Reichek, MD, Principal investigator, St. Francis Hospital-The Heart Center, Roslyn, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078272
- Sponsor's protocol ID
- 09-25
- Acronym
- SaFR
- Status last verified
- Mar 2020
- First submitted
- 1 Mar 2010
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Saint Francis Remote Ischemic Preconditioning Trial (SaFR)
- ClinicalTrials.gov ID
- NCT01078272
- Acronym / sponsor ID
- SaFR / 09-25
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Atherosclerosis, Percutaneous Coronary Intervention, Coronary Stenting, Coronary Stenosis, Remote Ischemic Preconditioning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment inadequate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- St. Francis Hospital, New YorkUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Preconditioning (RIPC) | Experimental | Other: Remote ischemic preconditioningRandomized 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. |
| Sham Remote Ischemic Preconditioning | Placebo comparator | Other: Sham Remote Ischemic PreconditioningPatients who prior to stenting have the RIPC blood pressure cuff placed but not inflated for 3 5 minute episodes with 5 minute rest periods. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with stable chronic coronary artery disease scheduled for elective percutaneous intervention.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic preconditioningRandomized 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. | Other | Remote Ischemic Preconditioning (RIPC) |
| Sham Remote Ischemic PreconditioningRandomized 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. | Other | Sham Remote Ischemic Preconditioning |
Primary outcome
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
5 secondary outcomes
troponin I
Time frame: 24 hours
chest pain during stenting
Time frame: immediate during procedure
ST segment changes during stent implantation
Time frame: immediate
MRI delayed enhancement
Time frame: 1-7 days after stenting
Late left ventricular volumes and ejection fraction
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment inadequate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- First randomized trial of RIPC for coronary stentingLink provided by the sponsor.
- editorial review of remote ischemic preconditioning in coronary diseaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Reichek, MD principal investigator
St. Francis Hospital-The Heart Center, Roslyn, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning in people with Coronary Artery Disease, run by St. Francis Hospital, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment inadequate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 6 months post-stenting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.