Myocardial InjuryPhase 1RIPCONNCT01608984
Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary Artery Bypass Grafting(RIPCON)
A Phase 1 study testing Remote ischemic preconditioning (RIPC), Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol and Off-pump Coronary artery bypass surgery without remote ischemic preconditioning in people with Myocardial Injury, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Purpose Remote ischemic preconditioning (RIPC) with transient upper limb ischemia reduces myocardial injury in patients undergoing On-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Injury
- What is being tested?
- Remote ischemic preconditioning (RIPC), Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol and Off-pump Coronary artery bypass surgery without remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Dec 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed triple vessel coronary artery disease
- Indication for surgical coronary revascularisation
- Written informed consent
- Age ≥ 18 years
Who cannot join
- Age > 80 years
- Instable angina/acute coronary syndrome
- Emergency surgery
- Recent myocardial infarction within 7 days prior to surgery
- Recent major infection/sepsis within 7 days prior to surgery
- Significant hepatic, renal oder pulmonary disease
- Other concomitant surgical procedures
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. Cardiovascular Surgery, University Hospital, Heinrich Heine University
Düsseldorf, 40225
Payam Akhyari, MD, +492118118331, payam.akhyari@med.uni-duesseldorf.de
Alexander Albert, MD, +492118118331, alexander.albert@med.uni-duesseldorf.de
About this study
Official title: Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary
Purpose Remote ischemic preconditioning (RIPC) with transient upper limb ischemia reduces myocardial injury in patients undergoing On-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The molecular mechanisms leading to these effects are yet not fully understood. The purpose of the present study is to validate previous studies and gather further evidence for RIPC during CABG with blood cardioplegia, furthermore to determine, whether or not RIPC is still operative during Off-pump coronary artery bypass surgery (OPCAB), finally to elucidate intra-cellular mechanisms involved in myocardial protection by RIPC and their possible systemic mediators.
Read the detailed description
Remote ischemic preconditioning (RIPC) protocol before CABG (study arm A) or OPCAB (study arm B) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest (A) or first coronary incision (B), and 5 to 10 minutes after aortic unclamping during reperfusion of the myocardium (A) or 5 to 10 minutes after the completion of the last anastomosis (B). Blood samples are taken prior to RIPC and during the first three postoperative days.
- Conditions
- Myocardial Injury
- Being tested
- Remote ischemic preconditioning (RIPC), Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol, Off-pump Coronary artery bypass surgery without remote ischemic preconditioning
- Keywords
- remote ischemic preconditioning, coronary artery bypass grafting, myocardial injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioning (RIPC)Procedure or surgery
Also called RIPC: remote ischemic preconditioning, CABG: coronary artery bypass grafting, OPCAB: Off-pump coronary artery bypass surgery, Isoflurane: 2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane, Forane
3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion.
The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. In the CABG-arms, during extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.
Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocolProcedure or surgery
The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.
Off-pump Coronary artery bypass surgery without remote ischemic preconditioningProcedure or surgery
The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required.
| Study group | Role | What they receive |
|---|---|---|
| RIPC-CABG | Active comparator | Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery with blood cardioplegia for cardiac arrest (CABG) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and 5 to 10 Minutes after aortic unclamping during reperfusion of the myocardium. Blood samples are taken up to 72 hours postoperatively. Receives: Procedure: Remote ischemic preconditioning (RIPC) |
| Control-CABG | Placebo comparator | Control group: Coronary artery bypass grafting without RIPC protocol Receives: Procedure: Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol |
| RIPC-OPCAB | Active comparator | Remote ischemic preconditioning (RIPC) protocol before Off-pump coronary artery bypass surgery (OPCAB) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before first coronary artery incision and 5 to 10 Minutes after completion of the coronary anastomoses. Blood samples are taken up to 72 hours postoperatively. Receives: Procedure: Remote ischemic preconditioning (RIPC) |
| Control-OPCAB | Placebo comparator | Control group: Off-pump Coronary artery bypass surgery without RIPC protocol Receives: Procedure: Off-pump Coronary artery bypass surgery without remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative extent of myocardial injury as measured by cardiac troponin T serum release over 72 hours after coronary bypass surgery and its area under the curve (AUC).
Measured: 72 hours postoperatively after CABG surgery
Secondary outcomes (5)
All-cause mortality
Measured: 30 days and 1 year after coronary bypass surgery
Major adverse cardiac and cerebrovascular events (MACCE)
Measured: 30 days and 1 year after coronary bypass surgery
Myocardial infarction
Measured: 30 days and 1 year after coronary bypass surgery
Renal function
Measured: 30 days and 1 year after coronary bypass surgery
circulating microparticles after coronary bypass surgery
Measured: perioperatively, 3 months and 1 year after coronary bypass surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
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 Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Essen
- Responsible party
- Sponsor
- Investigators
- Payam Akhyari, MD, Principal investigator, Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, GermanyAlexander Albert, MD, Principal investigator, Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, GermanyArtur Lichtenberg, MD, Principal investigator, Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, GermanyGerd Heusch, MD, PhD, Principal investigator, nst. of Pathophysiology, University Duisburg-Essen, University Hospital Essen, Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608984
- Sponsor's protocol ID
- RIPCON-12
- Acronym
- RIPCON
- Status last verified
- Jul 2013
- First submitted
- 29 May 2012
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hausenloy DJ, Erik Botker H, Condorelli G, Ferdinandy P, Garcia-Dorado D, Heusch G, Lecour S, van Laake LW, Madonna R, Ruiz-Meana M, Schulz R, Sluijter JP, Yellon DM, Ovize M. Translating cardioprotection for patient benefit: position paper from the Working Group of Cellular Biology of the Heart of the European Society of Cardiology. Cardiovasc Res. 2013 Apr 1;98(1):7-27. doi: 10.1093/cvr/cvt004. Epub 2013 Jan 19.
PubMed 23334258Heusch G, Musiolik J, Kottenberg E, Peters J, Jakob H, Thielmann M. STAT5 activation and cardioprotection by remote ischemic preconditioning in humans: short communication. Circ Res. 2012 Jan 6;110(1):111-5. doi: 10.1161/CIRCRESAHA.111.259556. Epub 2011 Nov 23.
PubMed 22116817
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic PreConditioning in Off-pump Versus On-pump Coronary
- ClinicalTrials.gov ID
- NCT01608984
- Acronym / sponsor ID
- RIPCON / RIPCON-12
- Conditions
- Myocardial Injury
- Keywords
- remote ischemic preconditioning, coronary artery bypass grafting, myocardial injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- University Hospital, Essen
- Study start
- May 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 May 2012 (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.
Purpose Remote ischemic preconditioning (RIPC) with transient upper limb ischemia reduces myocardial injury in patients undergoing On-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The molecular mechanisms leading to these effects are yet not fully understood. The purpose of the present study is to validate previous studies and gather further evidence for RIPC during CABG with blood cardioplegia, furthermore to determine, whether or not RIPC is still operative during Off-pump coronary artery bypass surgery (OPCAB), finally to elucidate intra-cellular mechanisms involved in myocardial protection by RIPC and their possible systemic mediators.
Detailed description
Remote ischemic preconditioning (RIPC) protocol before CABG (study arm A) or OPCAB (study arm B) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest (A) or first coronary incision (B), and 5 to 10 minutes after aortic unclamping during reperfusion of the myocardium (A) or 5 to 10 minutes after the completion of the last anastomosis (B). Blood samples are taken prior to RIPC and during the first three postoperative days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RIPC-CABG | Active comparator | Procedure: Remote ischemic preconditioning (RIPC)Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery with blood cardioplegia for cardiac arrest (CABG) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and 5 to 10 Minutes after aortic unclamping during reperfusion of the myocardium. Blood samples are taken up to 72 hours postoperatively. |
| Control-CABG | Placebo comparator | Procedure: Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocolControl group: Coronary artery bypass grafting without RIPC protocol |
| RIPC-OPCAB | Active comparator | Procedure: Remote ischemic preconditioning (RIPC)Remote ischemic preconditioning (RIPC) protocol before Off-pump coronary artery bypass surgery (OPCAB) consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before first coronary artery incision and 5 to 10 Minutes after completion of the coronary anastomoses. Blood samples are taken up to 72 hours postoperatively. |
| Control-OPCAB | Placebo comparator | Procedure: Off-pump Coronary artery bypass surgery without remote ischemic preconditioningControl group: Off-pump Coronary artery bypass surgery without RIPC protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed triple vessel coronary artery disease
- Indication for surgical coronary revascularisation
- Written informed consent
- Age ≥ 18 years
Key exclusion criteria (7 listed)
- Age > 80 years
- Instable angina/acute coronary syndrome
- Emergency surgery
- Recent myocardial infarction within 7 days prior to surgery
- Recent major infection/sepsis within 7 days prior to surgery
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 preconditioning (RIPC)Also: RIPC: remote ischemic preconditioning, CABG: coronary artery bypass grafting, OPCAB: Off-pump coronary artery bypass surgery, Isoflurane: 2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane, Forane3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion. The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. In the CABG-arms, during extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations. | Procedure or surgery | RIPC-CABG, RIPC-OPCAB |
| Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocolThe applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations. | Procedure or surgery | Control-CABG |
| Off-pump Coronary artery bypass surgery without remote ischemic preconditioningThe applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. | Procedure or surgery | Control-OPCAB |
Primary outcome
Perioperative extent of myocardial injury as measured by cardiac troponin T serum release over 72 hours after coronary bypass surgery and its area under the curve (AUC).
Time frame: 72 hours postoperatively after CABG surgery
5 secondary outcomes
All-cause mortality
Time frame: 30 days and 1 year after coronary bypass surgery
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 30 days and 1 year after coronary bypass surgery
Myocardial infarction
Time frame: 30 days and 1 year after coronary bypass surgery
Renal function
Time frame: 30 days and 1 year after coronary bypass surgery
circulating microparticles after coronary bypass surgery
Time frame: perioperatively, 3 months and 1 year after coronary bypass surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
- Background: PubMed 23334258Hausenloy DJ, Erik Botker H, Condorelli G, Ferdinandy P, Garcia-Dorado D, Heusch G, Lecour S, van Laake LW, Madonna R, Ruiz-Meana M, Schulz R, Sluijter JP, Yellon DM, Ovize M. Translating cardioprotection for patient benefit: position paper from the Working Group of Cellular Biology of the Heart of the European Society of Cardiology. Cardiovasc Res. 2013 Apr 1;98(1):7-27. doi: 10.1093/cvr/cvt004. Epub 2013 Jan 19.
- Background: PubMed 22116817Heusch G, Musiolik J, Kottenberg E, Peters J, Jakob H, Thielmann M. STAT5 activation and cardioprotection by remote ischemic preconditioning in humans: short communication. Circ Res. 2012 Jan 6;110(1):111-5. doi: 10.1161/CIRCRESAHA.111.259556. Epub 2011 Nov 23.
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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.
Payam Akhyari, MD principal investigator
Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Alexander Albert, MD principal investigator
Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
Artur Lichtenberg, MD principal investigator
Dept. of Cardiovascular Surgery, University Hospital, Heinrich Heine University, Duesseldorf, Germany
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 (RIPC), Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol and Off-pump Coronary artery bypass surgery without remote ischemic preconditioning in people with Myocardial Injury, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 4 inclusion and 7 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 16 Jul 2013. 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 Germany. 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 Payam Akhyari, MD (+492118118331, payam.akhyari@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative extent of myocardial injury as measured by cardiac troponin T serum release over 72 hours after coronary bypass surgery and its area under the curve (AUC). (time frame: 72 hours postoperatively after CABG 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 NCT01608984, 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 16 Jul 2013; AzTrials last refreshed its copy on 6 Nov 2026.