Coronary Artery DiseasePhase 2RIP-PCINCT00970827
Remote Ischemic Postconditioning During Percutaneous Coronary Interventions
A Phase 2 study testing remote ischemic postconditioning in people with Coronary Artery Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Angioplasty is a commonly performed procedure for treating blockage of the blood vessels in the heart. Although this procedure is usually successful, it is often accompanied by a small degree of damage to the heart (i.e., small heart attack). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- remote ischemic postconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Jun 2014
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for PCI
Who cannot join
- Acute myocardial infarction
- Myocardial infarction or coronary bypass surgery during the last 4 weeks before PCI
- Use of Glyburide
- Heart failure (NYHA III/IV)
- Chronic inflammatory disease
- Severe renal impairment
- Significant peripheral vascular disease
- Unsuitable for use of an embolic protection device for PCI to SVG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.
Angioplasty is a commonly performed procedure for treating blockage of the blood vessels in the heart. Although this procedure is usually successful, it is often accompanied by a small degree of damage to the heart (i.e., small heart attack).
The purpose of this study is to find out if inflating a blood pressure cuff on the arm or the leg at the time of angioplasty for several minutes has a beneficial effect.
Patients will be assigned to one of three treatment groups: inflating blood pressure cuff on the arm, inflating blood pressure cuff on the leg and a control group.
- Conditions
- Coronary Artery Disease
- Being tested
- remote ischemic postconditioning
- Keywords
- Coronary artery disease, PCI, Postconditioning, Elective or urgent PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic postconditioningProcedure or surgery
Three 5- minute cycles of blood pressure cuff inflation according to the assigned group. The cuff is inflated to 200 mm Hg (and at least 20 mmHg above the systolic blood pressure) for 5 minutes followed by a 5-minute deflation (reperfusion).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Leg postconditioning Receives: Procedure: remote ischemic postconditioning |
| 2 | Active comparator | Arm postconditioning Receives: Procedure: remote ischemic postconditioning |
| 3 | Placebo comparator | Control group Receives: Procedure: remote ischemic postconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury after PCI.
Measured: 24 hours
Secondary outcomes (3)
To study the effects of different degrees of remote ischemic postconditioning on myocardial necrosis and inflammation following PCI.
Measured: 24 hours
Platelet function
Measured: 24 hours
Cardiac events
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahar Lavi, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shahar Lavi, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970827
- Sponsor's protocol ID
- R-09-015
- Other IDs
- 15664
- Acronym
- RIP-PCI
- Status last verified
- Sep 2014
- First submitted
- 9 Jul 2009
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lavi S, Abu-Romeh N, Wall S, Alemayehu M, Lavi R. Long-term outcome following remote ischemic postconditioning during percutaneous coronary interventions-the RIP-PCI trial long-term follow-up. Clin Cardiol. 2017 May;40(5):268-274. doi: 10.1002/clc.22668. Epub 2017 Jan 11.
PubMed 28075499Lavi S, D'Alfonso S, Diamantouros P, Camuglia A, Garg P, Teefy P, Jablonsky G, Sridhar K, Lavi R. Remote ischemic postconditioning during percutaneous coronary interventions: remote ischemic postconditioning-percutaneous coronary intervention randomized trial. Circ Cardiovasc Interv. 2014 Apr;7(2):225-32. doi: 10.1161/CIRCINTERVENTIONS.113.000948. Epub 2014 Apr 1.
PubMed 24692535
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.
- ClinicalTrials.gov ID
- NCT00970827
- Acronym / sponsor ID
- RIP-PCI / R-09-015
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, PCI, Postconditioning, Elective or urgent PCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Sep 2009 (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.
Angioplasty is a commonly performed procedure for treating blockage of the blood vessels in the heart. Although this procedure is usually successful, it is often accompanied by a small degree of damage to the heart (i.e., small heart attack).
The purpose of this study is to find out if inflating a blood pressure cuff on the arm or the leg at the time of angioplasty for several minutes has a beneficial effect.
Patients will be assigned to one of three treatment groups: inflating blood pressure cuff on the arm, inflating blood pressure cuff on the leg and a control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: remote ischemic postconditioningLeg postconditioning |
| 2 | Active comparator | Procedure: remote ischemic postconditioningArm postconditioning |
| 3 | Placebo comparator | Procedure: remote ischemic postconditioningControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for PCI
Key exclusion criteria (8 listed)
- Acute myocardial infarction
- Myocardial infarction or coronary bypass surgery during the last 4 weeks before PCI
- Use of Glyburide
- Heart failure (NYHA III/IV)
- Chronic inflammatory disease
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 postconditioningThree 5- minute cycles of blood pressure cuff inflation according to the assigned group. The cuff is inflated to 200 mm Hg (and at least 20 mmHg above the systolic blood pressure) for 5 minutes followed by a 5-minute deflation (reperfusion). | Procedure or surgery | 1, 2, 3 |
Primary outcome
Myocardial injury after PCI.
Time frame: 24 hours
3 secondary outcomes
To study the effects of different degrees of remote ischemic postconditioning on myocardial necrosis and inflammation following PCI.
Time frame: 24 hours
Platelet function
Time frame: 24 hours
Cardiac events
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
- Derived from this study: PubMed 28075499Lavi S, Abu-Romeh N, Wall S, Alemayehu M, Lavi R. Long-term outcome following remote ischemic postconditioning during percutaneous coronary interventions-the RIP-PCI trial long-term follow-up. Clin Cardiol. 2017 May;40(5):268-274. doi: 10.1002/clc.22668. Epub 2017 Jan 11.
- Derived from this study: PubMed 24692535Lavi S, D'Alfonso S, Diamantouros P, Camuglia A, Garg P, Teefy P, Jablonsky G, Sridhar K, Lavi R. Remote ischemic postconditioning during percutaneous coronary interventions: remote ischemic postconditioning-percutaneous coronary intervention randomized trial. Circ Cardiovasc Interv. 2014 Apr;7(2):225-32. doi: 10.1161/CIRCINTERVENTIONS.113.000948. Epub 2014 Apr 1.
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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.
Shahar Lavi, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing remote ischemic postconditioning in people with Coronary Artery Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 8 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: finished, as of the sponsor's last update on 9 Sep 2014. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Myocardial injury after PCI. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00970827, which also lists 2 linked publications.
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 9 Sep 2014.