Coronary Heart DiseasePhase 1NCT00397163
Effect of Remote Ischemic Preconditioning in Patient Undergoing Cardiac Bypass Surgery
A Phase 1 study testing Remote ischemic preconditioning in people with Coronary Heart Disease, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
During coronary artery bypass graft surgery, injury occurs to the heart muscle. Some of this injury is due to the deprivation of oxygen and nutrients to the heart (a process called ischemia) during the surgery itself. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary 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
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2010to 13 Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing elective CABG surgery
Who cannot join
- <18 years old
- Significant renal or hepatic disease
- Previous acute myocardial infarction (within 4 weeks)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The UCLH Heart Hospital, 14-16 Westmoreland St.
London, W1G 8PH
About this study
Official title: A Clinical Study Investigating Ischemic Preconditioning in Type II Diabetic Patients Undergoing Coronary Artery Bypass Graft Surgery.
During coronary artery bypass graft surgery, injury occurs to the heart muscle. Some of this injury is due to the deprivation of oxygen and nutrients to the heart (a process called ischemia) during the surgery itself. The objective of this study is to examine whether remote ischaemic preconditioning (RIPC), in which the application of transient ischemia to the forearm and thigh (through the inflation of blood pressure cuffs placed on the right upper arm and upper thigh) may reduce the injury to the heart muscle sustained during cardiac surgery.
The study hypothesis is: remote ischemic preconditioning will protect the heart and improve short-term clinical outcomes during coronary artery bypass graft surgery.
Read the detailed description
Ischemic heart disease (IHD) is currently the leading cause of morbidity and mortality in the developed world, and is set to become the leading cause of death in the world by the year 2020, according to the World Health Organisation. Patients with severe IHD that require coronary artery bypass graft (CABG) surgery, although protected by techniques such as cross-clamp fibrillation and cardioplegia, still sustain significant myocardial injury as evidenced by perioperative troponin T or I or CK-MB release. Novel treatment strategies are required to limit the myocardial injury sustained by patients undergoing CABG surgery in order to improve the clinical outcomes of this patient group.
One such cardioprotective strategy is remote ischemic preconditioning(RIPC) which describes the cardioprotection obtained from inducing ischemia in tissue or an organ remote from the heart. Our laboratory and others have established RIPC using forearm ischemia (induced by an automated cuff applied to the upper arm) as an effective cardioprotective intervention in children undergoing corrective cardiac surgery for congenital heart disease and in adults undergoing CABG surgery. In this study we investigate whether simultaneous inflation/deflation of cuffs placed on the upper arm and thigh can reduce peri-operative myocardial injury and improve short-term outcomes in patients undergoing CABG surgery.
Eligible patients will be those patients undergoing elective CABG surgery who are >18 years old, with no significant renal or hepatic disease, and have not had a recent AMI (within 1 month).
Consented patients will randomized to RIPC treatment or control.The RIPC protocol will comprise simultaneous 2 x 5 minutes of forearm and lower leg ischemia (with an automated pressure cuff inflated to 200 mmHg) with an intervening 5 minutes of reperfusion (during which the cuff is deflated) between each inflation. The control protocol will comprise a deflated cuff being placed on the upper arm and thigh for 20 minutes. The RIPC protocol will be implemented after the patients have been anesthetized and immediately prior to CABG surgery.
The measured endpoint of cardioprotection will be troponin-T release at 0, 12, 24, 48 and 72 hours following CABG surgery.
- Conditions
- Coronary Heart Disease
- Being tested
- Remote ischemic preconditioning, Placebo
- Keywords
- Coronary artery bypass graft surgery, Remote ischemic preconditioning, Troponin-T
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
Also called Remote Ischaemic Preconditioning
Blood pressure cuff inflation
PlaceboProcedure or surgery
Also called Control
Deflated cuff on upper arm and thigh for 20 min
| Study group | Role | What they receive |
|---|---|---|
| Remote preconditioning | Active comparator | Simultaneous inflation (5min) and deflation (5min) of cuffs placed on upper arm and thigh - cycle repeated 2 times Receives: Procedure: Remote ischemic preconditioning |
| Placebo | Placebo comparator | Deflated cuffs placed on upperarm and thigh for 20 minutes Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin-T release over the perioperative 72-hour period.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startDec 2010
- Primary completion13 Jan 2017
- Study completion13 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Yellon, University College London Hospitals
- Investigators
- Derek M Yellon, PhD DSc, Principal investigator, The Hatter Cardiovascular Institute, UCL.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397163
- Sponsor's protocol ID
- 01/0128
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2006
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kharbanda RK, Li J, Konstantinov IE, Cheung MM, White PA, Frndova H, Stokoe J, Cox P, Vogel M, Van Arsdell G, MacAllister R, Redington AN. Remote ischaemic preconditioning protects against cardiopulmonary bypass-induced tissue injury: a preclinical study. Heart. 2006 Oct;92(10):1506-11. doi: 10.1136/hrt.2004.042366. Epub 2006 Jul 3.
PubMed 16818489Loukogeorgakis SP, Panagiotidou AT, Broadhead MW, Donald A, Deanfield JE, MacAllister RJ. Remote ischemic preconditioning provides early and late protection against endothelial ischemia-reperfusion injury in humans: role of the autonomic nervous system. J Am Coll Cardiol. 2005 Aug 2;46(3):450-6. doi: 10.1016/j.jacc.2005.04.044.
PubMed 16053957Broadhead MW, Kharbanda RK, Peters MJ, MacAllister RJ. KATP channel activation induces ischemic preconditioning of the endothelium in humans in vivo. Circulation. 2004 Oct 12;110(15):2077-82. doi: 10.1161/01.CIR.0000144304.91010.F0. Epub 2004 Oct 4.
PubMed 15466634Kharbanda RK, Mortensen UM, White PA, Kristiansen SB, Schmidt MR, Hoschtitzky JA, Vogel M, Sorensen K, Redington AN, MacAllister R. Transient limb ischemia induces remote ischemic preconditioning in vivo. Circulation. 2002 Dec 3;106(23):2881-3. doi: 10.1161/01.cir.0000043806.51912.9b.
PubMed 12460865Kharbanda RK, Peters M, Walton B, Kattenhorn M, Mullen M, Klein N, Vallance P, Deanfield J, MacAllister R. Ischemic preconditioning prevents endothelial injury and systemic neutrophil activation during ischemia-reperfusion in humans in vivo. Circulation. 2001 Mar 27;103(12):1624-30. doi: 10.1161/01.cir.103.12.1624.
PubMed 11273988Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.
PubMed 16750696Konstantinov IE, Li J, Cheung MM, Shimizu M, Stokoe J, Kharbanda RK, Redington AN. Remote ischemic preconditioning of the recipient reduces myocardial ischemia-reperfusion injury of the denervated donor heart via a Katp channel-dependent mechanism. Transplantation. 2005 Jun 27;79(12):1691-5. doi: 10.1097/01.tp.0000159137.76400.5d.
PubMed 15973170Kristiansen SB, Henning O, Kharbanda RK, Nielsen-Kudsk JE, Schmidt MR, Redington AN, Nielsen TT, Botker HE. Remote preconditioning reduces ischemic injury in the explanted heart by a KATP channel-dependent mechanism. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1252-6. doi: 10.1152/ajpheart.00207.2004. Epub 2004 Oct 21.
PubMed 15498829Konstantinov IE, Arab S, Kharbanda RK, Li J, Cheung MM, Cherepanov V, Downey GP, Liu PP, Cukerman E, Coles JG, Redington AN. The remote ischemic preconditioning stimulus modifies inflammatory gene expression in humans. Physiol Genomics. 2004 Sep 16;19(1):143-50. doi: 10.1152/physiolgenomics.00046.2004. Epub 2004 Aug 10.
PubMed 15304621Candilio L, Malik A, Ariti C, Barnard M, Di Salvo C, Lawrence D, Hayward M, Yap J, Roberts N, Sheikh A, Kolvekar S, Hausenloy DJ, Yellon DM. Effect of remote ischaemic preconditioning on clinical outcomes in patients undergoing cardiac bypass surgery: a randomised controlled clinical trial. Heart. 2015 Feb;101(3):185-92. doi: 10.1136/heartjnl-2014-306178. Epub 2014 Sep 24.
PubMed 25252696Venugopal V, Hausenloy DJ, Ludman A, Di Salvo C, Kolvekar S, Yap J, Lawrence D, Bognolo J, Yellon DM. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing cardiac surgery with cold-blood cardioplegia: a randomised controlled trial. Heart. 2009 Oct;95(19):1567-71. doi: 10.1136/hrt.2008.155770. Epub 2009 Jun 8.
PubMed 19508973Hausenloy 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 17707752
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Investigating Ischemic Preconditioning in Type II Diabetic Patients Undergoing Coronary Artery Bypass Graft Surgery.
- ClinicalTrials.gov ID
- NCT00397163
- Acronym / sponsor ID
- 01/0128
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary artery bypass graft surgery, Remote ischemic preconditioning, Troponin-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- 13 Jan 2017 (actual)
- Study completion
- 13 Jan 2017 (actual)
- First posted
- 8 Nov 2006 (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.
During coronary artery bypass graft surgery, injury occurs to the heart muscle. Some of this injury is due to the deprivation of oxygen and nutrients to the heart (a process called ischemia) during the surgery itself. The objective of this study is to examine whether remote ischaemic preconditioning (RIPC), in which the application of transient ischemia to the forearm and thigh (through the inflation of blood pressure cuffs placed on the right upper arm and upper thigh) may reduce the injury to the heart muscle sustained during cardiac surgery.
The study hypothesis is: remote ischemic preconditioning will protect the heart and improve short-term clinical outcomes during coronary artery bypass graft surgery.
Detailed description
Ischemic heart disease (IHD) is currently the leading cause of morbidity and mortality in the developed world, and is set to become the leading cause of death in the world by the year 2020, according to the World Health Organisation. Patients with severe IHD that require coronary artery bypass graft (CABG) surgery, although protected by techniques such as cross-clamp fibrillation and cardioplegia, still sustain significant myocardial injury as evidenced by perioperative troponin T or I or CK-MB release. Novel treatment strategies are required to limit the myocardial injury sustained by patients undergoing CABG surgery in order to improve the clinical outcomes of this patient group.
One such cardioprotective strategy is remote ischemic preconditioning(RIPC) which describes the cardioprotection obtained from inducing ischemia in tissue or an organ remote from the heart. Our laboratory and others have established RIPC using forearm ischemia (induced by an automated cuff applied to the upper arm) as an effective cardioprotective intervention in children undergoing corrective cardiac surgery for congenital heart disease and in adults undergoing CABG surgery. In this study we investigate whether simultaneous inflation/deflation of cuffs placed on the upper arm and thigh can reduce peri-operative myocardial injury and improve short-term outcomes in patients undergoing CABG surgery.
Eligible patients will be those patients undergoing elective CABG surgery who are >18 years old, with no significant renal or hepatic disease, and have not had a recent AMI (within 1 month).
Consented patients will randomized to RIPC treatment or control.The RIPC protocol will comprise simultaneous 2 x 5 minutes of forearm and lower leg ischemia (with an automated pressure cuff inflated to 200 mmHg) with an intervening 5 minutes of reperfusion (during which the cuff is deflated) between each inflation. The control protocol will comprise a deflated cuff being placed on the upper arm and thigh for 20 minutes. The RIPC protocol will be implemented after the patients have been anesthetized and immediately prior to CABG surgery.
The measured endpoint of cardioprotection will be troponin-T release at 0, 12, 24, 48 and 72 hours following CABG surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote preconditioning | Active comparator | Procedure: Remote ischemic preconditioningSimultaneous inflation (5min) and deflation (5min) of cuffs placed on upper arm and thigh - cycle repeated 2 times |
| Placebo | Placebo comparator | Procedure: PlaceboDeflated cuffs placed on upperarm and thigh for 20 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing elective CABG surgery
Key exclusion criteria (3 listed)
- <18 years old
- Significant renal or hepatic disease
- Previous acute myocardial infarction (within 4 weeks)
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 preconditioningAlso: Remote Ischaemic PreconditioningBlood pressure cuff inflation | Procedure or surgery | Remote preconditioning |
| PlaceboAlso: ControlDeflated cuff on upper arm and thigh for 20 min | Procedure or surgery | Placebo |
Primary outcome
Troponin-T release over the perioperative 72-hour period.
Time frame: 3 days
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 29 Nov 2023.
- Background: PubMed 16818489Kharbanda RK, Li J, Konstantinov IE, Cheung MM, White PA, Frndova H, Stokoe J, Cox P, Vogel M, Van Arsdell G, MacAllister R, Redington AN. Remote ischaemic preconditioning protects against cardiopulmonary bypass-induced tissue injury: a preclinical study. Heart. 2006 Oct;92(10):1506-11. doi: 10.1136/hrt.2004.042366. Epub 2006 Jul 3.
- Background: PubMed 16053957Loukogeorgakis SP, Panagiotidou AT, Broadhead MW, Donald A, Deanfield JE, MacAllister RJ. Remote ischemic preconditioning provides early and late protection against endothelial ischemia-reperfusion injury in humans: role of the autonomic nervous system. J Am Coll Cardiol. 2005 Aug 2;46(3):450-6. doi: 10.1016/j.jacc.2005.04.044.
- Background: PubMed 15466634Broadhead MW, Kharbanda RK, Peters MJ, MacAllister RJ. KATP channel activation induces ischemic preconditioning of the endothelium in humans in vivo. Circulation. 2004 Oct 12;110(15):2077-82. doi: 10.1161/01.CIR.0000144304.91010.F0. Epub 2004 Oct 4.
- Background: PubMed 12460865Kharbanda RK, Mortensen UM, White PA, Kristiansen SB, Schmidt MR, Hoschtitzky JA, Vogel M, Sorensen K, Redington AN, MacAllister R. Transient limb ischemia induces remote ischemic preconditioning in vivo. Circulation. 2002 Dec 3;106(23):2881-3. doi: 10.1161/01.cir.0000043806.51912.9b.
- Background: PubMed 11273988Kharbanda RK, Peters M, Walton B, Kattenhorn M, Mullen M, Klein N, Vallance P, Deanfield J, MacAllister R. Ischemic preconditioning prevents endothelial injury and systemic neutrophil activation during ischemia-reperfusion in humans in vivo. Circulation. 2001 Mar 27;103(12):1624-30. doi: 10.1161/01.cir.103.12.1624.
- Background: PubMed 16750696Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.
- Background: PubMed 15973170Konstantinov IE, Li J, Cheung MM, Shimizu M, Stokoe J, Kharbanda RK, Redington AN. Remote ischemic preconditioning of the recipient reduces myocardial ischemia-reperfusion injury of the denervated donor heart via a Katp channel-dependent mechanism. Transplantation. 2005 Jun 27;79(12):1691-5. doi: 10.1097/01.tp.0000159137.76400.5d.
- Background: PubMed 15498829Kristiansen SB, Henning O, Kharbanda RK, Nielsen-Kudsk JE, Schmidt MR, Redington AN, Nielsen TT, Botker HE. Remote preconditioning reduces ischemic injury in the explanted heart by a KATP channel-dependent mechanism. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1252-6. doi: 10.1152/ajpheart.00207.2004. Epub 2004 Oct 21.
- Background: PubMed 15304621Konstantinov IE, Arab S, Kharbanda RK, Li J, Cheung MM, Cherepanov V, Downey GP, Liu PP, Cukerman E, Coles JG, Redington AN. The remote ischemic preconditioning stimulus modifies inflammatory gene expression in humans. Physiol Genomics. 2004 Sep 16;19(1):143-50. doi: 10.1152/physiolgenomics.00046.2004. Epub 2004 Aug 10.
- Derived from this study: PubMed 25252696Candilio L, Malik A, Ariti C, Barnard M, Di Salvo C, Lawrence D, Hayward M, Yap J, Roberts N, Sheikh A, Kolvekar S, Hausenloy DJ, Yellon DM. Effect of remote ischaemic preconditioning on clinical outcomes in patients undergoing cardiac bypass surgery: a randomised controlled clinical trial. Heart. 2015 Feb;101(3):185-92. doi: 10.1136/heartjnl-2014-306178. Epub 2014 Sep 24.
- Derived from this study: PubMed 19508973Venugopal V, Hausenloy DJ, Ludman A, Di Salvo C, Kolvekar S, Yap J, Lawrence D, Bognolo J, Yellon DM. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing cardiac surgery with cold-blood cardioplegia: a randomised controlled trial. Heart. 2009 Oct;95(19):1567-71. doi: 10.1136/hrt.2008.155770. Epub 2009 Jun 8.
- Derived from this study: 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.
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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.
Derek M Yellon, PhD DSc principal investigator
The Hatter Cardiovascular Institute, UCL.
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 Coronary Heart Disease, run by University College London Hospitals at 1 site in United Kingdom.
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 3 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 29 Nov 2023. 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 Kingdom. 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?
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?
Troponin-T release over the perioperative 72-hour period. (time frame: 3 days). 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 NCT00397163, which also lists 12 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 29 Nov 2023.