CABGNCT01956708
Transfer of Cardioprotection During RIPC
A study testing RIPC in people with CABG, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion provides peri-operative myocardial protection, is safe and improves prognosis in patients undergoing elective CABG surgery. The signal transfer from limb to heart is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CABG
- What is being tested?
- RIPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 392 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to 20 Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients > 18 years after written informed consent
- elective, isolated CABG surgery with and without valvuloplastic surgery
- two-stage cannulation, cardiopulmonary bypass
- antegrade Bretschneider cardioplegia
- mild hypothermia (32°C)
- preoperative standard medication (statins, betablocker, aspirin)
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- standard anesthesia (see above)
- intraoperative standard protocol (full heparinization with ACT, aprotinin, protamin)
- postoperative standard protocol (500 mg aspirin after 2 h, low-dose heparin after 4 h)
Who cannot join
- preoperative
- prior percutaneous coronary intervention (PCI) within 6 weeks
- any preoperative troponin T elevation
- renal insufficiency (creatinine >200 µmol/l)
- reoperation
- emergency surgery
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- acute coronary syndrome (unstable angina, STEMI, NSTEMI) within 4 weeks
- dual anti-platelet therapy (clopidogrel+aspirin)
- intraoperative
- harvesting of a. radialis
- coronary thrombendarterectomy
- complications (bypass-low flow/ -occlusion)
- antithrombotic therapy (intraoperative clopidogrel + aspirin)
- retrograde cardioplegia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen
Essen, 4130
About this study
Official title: Transfer of Cardioprotection During Remote Ischemic Conditioning
Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion provides peri-operative myocardial protection, is safe and improves prognosis in patients undergoing elective CABG surgery.
The signal transfer from limb to heart is unknown. Thus, the aim of this study is to identify the pathways which transfer the cardioprotective signal from the ischemic/reperfused extremity to the heart in humans undergoing surgical coronary revascularization.
Read the detailed description
The investigators will obtain arterial blood samples before skin incision and 1-72 h after the remote ischemic preconditioning protocol and analyze them biochemically. The investigators focus on those ligands that have been previously implicated in conditioning protocols at any organ. In addition, the investigators will use a bioassay system, consisting of a Langendorff-perfused isolated heart with coronary occlusion/reperfusion and infarct size by TTC staining as endpoint, and then expose this bioassay system to arterial plasma obtained after the remote ischemic preconditioning stimulus or placebo. This approach will allow us to further characterize any potential transfer signal candidate with a pharmacological antagonist approach.
The investigators will also obtain human atrial appendages after the remote ischemic preconditioning protocol or placebo and before patients were connected to the extracorporeal circulation. Contractile function of isolated trabeculae and vasomotor function of isolated arterial vessels will be analyzed in a bioassay system.
- Conditions
- CABG
- Being tested
- RIPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPCProcedure or surgery
Also called RIPC: Remote ischemic preconditioning
3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic preconditioning | Active comparator | Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery (CABG):
after induction of anesthesia and before surgery: 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200mmHg and 5 minutes of reperfusion Anesthesia is with isoflurane (0.7-0.8% end-tidal) +sufentanil Receives: Procedure: RIPC |
| Placebo | Placebo comparator | No Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery (CABG):
after induction of anesthesia and before surgery: the cuff is left uninflated Receives: Procedure: RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial protection
Cumulative postoperative troponin T release
Measured: 72 h, postoperatively
Secondary outcomes (5)
All-cause mortality
follow up done by studynurses
Measured: 30 days and 1 year after CABG surgery and after complete follow-up
MACCE
Major adverse cardiac and cerebrovascular events
Measured: 30 days and 1 year after CABG surgery after complete follow-up
renal function
Creatinine and eGFR
Measured: 72 h, postoperatively
Cardioprotective factors released into circulating blood
Analysis of blood plasma
Measured: before skin incision versus 1-72 h after RIPC
Myocardial function in vitro
left ventricular pressure (lvp) and maximum left ventricular pressure (lvdp) in an isolated perfused rodent heart after blood plasma infusion
Measured: after RIPC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABGStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Markus Kamler, University Hospital, Essen
- Investigators
- Markus Kamler, MD, Principal investigator, Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen, Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956708
- Sponsor's protocol ID
- RIPC-13-5507-BO
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2013
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Cardioprotection During Remote Ischemic Conditioning
- ClinicalTrials.gov ID
- NCT01956708
- Acronym / sponsor ID
- RIPC-13-5507-BO
- Conditions
- CABG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 8 Oct 2013 (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 ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion provides peri-operative myocardial protection, is safe and improves prognosis in patients undergoing elective CABG surgery.
The signal transfer from limb to heart is unknown. Thus, the aim of this study is to identify the pathways which transfer the cardioprotective signal from the ischemic/reperfused extremity to the heart in humans undergoing surgical coronary revascularization.
Detailed description
The investigators will obtain arterial blood samples before skin incision and 1-72 h after the remote ischemic preconditioning protocol and analyze them biochemically. The investigators focus on those ligands that have been previously implicated in conditioning protocols at any organ. In addition, the investigators will use a bioassay system, consisting of a Langendorff-perfused isolated heart with coronary occlusion/reperfusion and infarct size by TTC staining as endpoint, and then expose this bioassay system to arterial plasma obtained after the remote ischemic preconditioning stimulus or placebo. This approach will allow us to further characterize any potential transfer signal candidate with a pharmacological antagonist approach.
The investigators will also obtain human atrial appendages after the remote ischemic preconditioning protocol or placebo and before patients were connected to the extracorporeal circulation. Contractile function of isolated trabeculae and vasomotor function of isolated arterial vessels will be analyzed in a bioassay system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning | Active comparator | Procedure: RIPCRemote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery (CABG): after induction of anesthesia and before surgery: 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200mmHg and 5 minutes of reperfusion Anesthesia is with isoflurane (0.7-0.8% end-tidal) +sufentanil |
| Placebo | Placebo comparator | Procedure: RIPCNo Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery (CABG): after induction of anesthesia and before surgery: the cuff is left uninflated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Consecutive patients > 18 years after written informed consent
- elective, isolated CABG surgery with and without valvuloplastic surgery
- two-stage cannulation, cardiopulmonary bypass
- antegrade Bretschneider cardioplegia
- mild hypothermia (32°C)
Key exclusion criteria (14 listed)
- preoperative
- prior percutaneous coronary intervention (PCI) within 6 weeks
- any preoperative troponin T elevation
- renal insufficiency (creatinine >200 µmol/l)
- reoperation
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 |
|---|---|---|
| RIPCAlso: RIPC: Remote ischemic preconditioning3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion | Procedure or surgery | Placebo, Remote ischemic preconditioning |
Primary outcome
Myocardial protection
Time frame: 72 h, postoperatively
Cumulative postoperative troponin T release
5 secondary outcomes
All-cause mortality
Time frame: 30 days and 1 year after CABG surgery and after complete follow-up
MACCE
Time frame: 30 days and 1 year after CABG surgery after complete follow-up
renal function
Time frame: 72 h, postoperatively
Cardioprotective factors released into circulating blood
Time frame: before skin incision versus 1-72 h after RIPC
Myocardial function in vitro
Time frame: after RIPC
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 18 Oct 2021.
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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.
Markus Kamler, MD principal investigator
Herzzentrum Essen - Huttrop gGmbH, Einrichtung des Universitätsklinikums Essen, Essen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPC in people with CABG, run by University Hospital, Essen 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 9 inclusion and 14 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 18 Oct 2021. 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.
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 protection (time frame: 72 h, postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2021.