Ischemic Heart DiseasePhase 1NCT00953368
Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft
A Phase 1 study testing remote ischemic preconditioning in people with Ischemic Heart Disease, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the effects of remote ischemic preconditioning on cognitive function in patients undergoing off-pump coronary artery bypass graft. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Mar 2012
- Phase
- Phase 1
- 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 undergoing elective off-pump coronary artery bypass graft surgery
Who cannot join
- Emergency operation
- Preoperative use of inotropic drugs or mechanical assistant device
- Ejection fraction less than 30%
- Combined operation using CPB such as valve surgery
- Previous psychiatric and neurologic disorder
- Inability to perform the cognitive function test
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, University of Ulsan, College of Medicine, Asan Medical Center
Seoul, Seoul, 138-736
In-Cheol Choi, professor, +82-2-3010-3862, icchoi@amc.seoul.kr
Dae-Kee Choi, fellow, +82-2-3010-5633, d001109@hanmail.net
About this study
The aim of this study is to evaluate the effects of remote ischemic preconditioning on cognitive function in patients undergoing off-pump coronary artery bypass graft.
- Conditions
- Ischemic Heart Disease
- Being tested
- remote ischemic preconditioning
- Keywords
- remote ischemic preconditioning, cognitive function, off-pump coronary artery bypass graft
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioningProcedure or surgery
Remote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic preconditioning | Active comparator | Remote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis Receives: Procedure: remote ischemic preconditioning |
| control | Placebo comparator | sham placement of a blood-pressure cuff around the upper limb without inflation Receives: Procedure: remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
Measured: preoperative, 1 week and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- In-Cheol Choi, professor, Principal investigator, Asan Medical Center, Department of Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953368
- Sponsor's protocol ID
- RIPC-3862
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van Dijk D, Jansen EW, Hijman R, Nierich AP, Diephuis JC, Moons KG, Lahpor JR, Borst C, Keizer AM, Nathoe HM, Grobbee DE, De Jaegere PP, Kalkman CJ; Octopus Study Group. Cognitive outcome after off-pump and on-pump coronary artery bypass graft surgery: a randomized trial. JAMA. 2002 Mar 20;287(11):1405-12. doi: 10.1001/jama.287.11.1405.
PubMed 11903027
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT00953368
- Acronym / sponsor ID
- RIPC-3862
- Conditions
- Ischemic Heart Disease
- Keywords
- remote ischemic preconditioning, cognitive function, off-pump coronary artery bypass graft
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 6 Aug 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.
The aim of this study is to evaluate the effects of remote ischemic preconditioning on cognitive function in patients undergoing off-pump coronary artery bypass graft.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning | Active comparator | Procedure: remote ischemic preconditioningRemote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis |
| control | Placebo comparator | Procedure: remote ischemic preconditioningsham placement of a blood-pressure cuff around the upper limb without inflation |
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 undergoing elective off-pump coronary artery bypass graft surgery
Key exclusion criteria (6 listed)
- Emergency operation
- Preoperative use of inotropic drugs or mechanical assistant device
- Ejection fraction less than 30%
- Combined operation using CPB such as valve surgery
- Previous psychiatric and neurologic disorder
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 preconditioningRemote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis | Procedure or surgery | Remote ischemic preconditioning, control |
Primary outcome
cognitive function
Time frame: preoperative, 1 week and 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
- Background: PubMed 11903027Van Dijk D, Jansen EW, Hijman R, Nierich AP, Diephuis JC, Moons KG, Lahpor JR, Borst C, Keizer AM, Nathoe HM, Grobbee DE, De Jaegere PP, Kalkman CJ; Octopus Study Group. Cognitive outcome after off-pump and on-pump coronary artery bypass graft surgery: a randomized trial. JAMA. 2002 Mar 20;287(11):1405-12. doi: 10.1001/jama.287.11.1405.
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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.
In-Cheol Choi, professor principal investigator
Asan Medical Center, Department of Anesthesiology and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing remote ischemic preconditioning in people with Ischemic Heart Disease, run by Asan Medical Center at 1 site in South Korea.
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 6 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: status not confirmed, as of the sponsor's last update on 6 Aug 2009. 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 South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact In-Cheol Choi, professor (+82-2-3010-3862, icchoi@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function (time frame: preoperative, 1 week and 6 months after surgery). 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 NCT00953368, which also lists 1 linked publication.
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 6 Aug 2009.