Heart Valve DiseasesNCT01175681
Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
A study testing remote ischaemic preconditioning in people with Heart Valve Diseases, run by Sun Yat-sen University at 1 site in China.
Trial summary
Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm. However, no data was reported on heart valve disease surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- remote ischaemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- Dec 2007to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All heart valve diseases needing heart valve surgery.
Who cannot join
- All four limbs existed ischemic condition
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, 510180
About this study
Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm. However, no data was reported on heart valve disease surgery. Rheumatic heart disease is one of the major heart diseases requiring surgery in China. Thus, the investigators chose heart valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac protective effect during heart valve surgery.
- Conditions
- Heart Valve Diseases
- Being tested
- remote ischaemic preconditioning
- Keywords
- rheumatic heart disease, degenerated heart valve disease, heart valve prolapse
- Medical subject headings
- Heart Valve Diseases, Rheumatic Heart Disease, Heart Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischaemic preconditioningProcedure or surgery
Remote ischaemic preconditioning consisted of three 5-min cycles of right upper arm ischaemia, which was induced by an automated cuff -inflator placed on the right upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated. There was a 5- to 10-min interval between completion of the remote ischaemic preconditioning protocol and initiation of bypass.Control patients had a deflated cuff placed on the right upper arm for 30 min.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | remote ischaemic preconditioning Receives: Procedure: remote ischaemic preconditioning |
| untreated | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma troponin I level
The investigators will measure the plasma troponin I level in several time points before and after surgery in each patient.
Measured: with 7 days after surgery
Secondary outcomes (1)
serum creatinine
Measured: within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startDec 2007
- Primary completionMar 2011
- Study completionJun 2011
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 Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou First People's Hospital
- Investigators
- Jing-song Ou, MD,PhD, Principal investigator, The Frist Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175681
- Sponsor's protocol ID
- ischemia
- Status last verified
- Jul 2010
- First submitted
- 3 Aug 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
PubMed 17707752Xie JJ, Liao XL, Chen WG, Huang DD, Chang FJ, Chen W, Luo ZL, Wang ZP, Ou JS. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing heart valve surgery: randomised controlled trial. Heart. 2012 Mar;98(5):384-8. doi: 10.1136/heartjnl-2011-300860. Epub 2011 Nov 22.
PubMed 22107759
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery
- ClinicalTrials.gov ID
- NCT01175681
- Acronym / sponsor ID
- ischemia
- Conditions
- Heart Valve Diseases
- Keywords
- rheumatic heart disease, degenerated heart valve disease, heart valve prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou First People's Hospital
- Study start
- Dec 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 5 Aug 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.
Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm. However, no data was reported on heart valve disease surgery. Rheumatic heart disease is one of the major heart diseases requiring surgery in China. Thus, the investigators chose heart valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac protective effect during heart valve surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Procedure: remote ischaemic preconditioningremote ischaemic preconditioning |
| untreated | No intervention | –control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All heart valve diseases needing heart valve surgery.
Key exclusion criteria (1 listed)
- All four limbs existed ischemic condition
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 ischaemic preconditioningRemote ischaemic preconditioning consisted of three 5-min cycles of right upper arm ischaemia, which was induced by an automated cuff -inflator placed on the right upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated. There was a 5- to 10-min interval between completion of the remote ischaemic preconditioning protocol and initiation of bypass.Control patients had a deflated cuff placed on the right upper arm for 30 min. | Procedure or surgery | treatment |
Primary outcome
plasma troponin I level
Time frame: with 7 days after surgery
The investigators will measure the plasma troponin I level in several time points before and after surgery in each patient.
1 secondary outcome
serum creatinine
Time frame: within 7 days after surgery
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 21 Jul 2011.
- Background: PubMed 17707752Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
- Derived from this study: PubMed 22107759Xie JJ, Liao XL, Chen WG, Huang DD, Chang FJ, Chen W, Luo ZL, Wang ZP, Ou JS. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing heart valve surgery: randomised controlled trial. Heart. 2012 Mar;98(5):384-8. doi: 10.1136/heartjnl-2011-300860. Epub 2011 Nov 22.
- PubmedLink 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.
Jing-song Ou, MD,PhD principal investigator
The Frist Affiliated Hospital, Sun Yat-sen University
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 ischaemic preconditioning in people with Heart Valve Diseases, run by Sun Yat-sen University at 1 site in China.
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 1 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 21 Jul 2011. 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 China. 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. 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 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?
plasma troponin I level (time frame: with 7 days 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 NCT01175681, 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 21 Jul 2011.