Coronary Artery BypassPhase 2RICARDONCT03363958
Remote Ischemic Conditioning to Attenuate Myocardial Death and Improve Operative Outcome.
A Phase 2 study testing Remote Ischemic Preconditioning with Postconditioning in people with Coronary Artery Bypass and Myocardial Reperfusion Injur, run by Medinet Heart Centre at 1 site in Poland.
Trial summary
This study evaluates the addition of remote ischemic preconditioning and postconditioning to standard myocardial protection protocol in patients submitted to off - pump coronary artery bypass grafting in a prospective, 1:1 randomized, double blind fashion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Bypass, Myocardial Reperfusion Injur, Ischemic Preconditioning, Myocardial
- What is being tested?
- Remote Ischemic Preconditioning with Postconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2014to 1 Jan 2020
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients qualified to coronary artery bypass grafting according to ESC/EACTS Guidelines of myocardial revascularization, suffering from:
- Multivessel coronary artery disease amenable for surgical treatment
- Negative history of previous cardiac or vascular surgery in childhood and afterwards.
- Negative history of active neoplastic disease, neither past medical history of oncological treatment
- Patients with non insulin dependent diabetes mellitus treated chronically with oral derivatives of sulfonylourea such as but not limited to: glibenclamide.
Who cannot join
- Patients suffering from acute insuficiency of any organ/ system and those suffering from end stage organ failure such as:
- Chronic renal disease - KDOQI stage ≥ 3;
- Chronic renal failure class A by Child - Pugh'a;
- Chronic respiratory failure (type I and II according to Campbell et al. and type I according to Wood et al.);
- Chronic intermittent claudication class 2A according to Fontaine;
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medinet Heart Centre
Nowa Sól, Lubusz Voivodeship, 67-100
Sleiman Sebastian Aboul-Hassan, MD, s.aboulhassan@gmail.com
About this study
Official title: Effect of Remote Ischemic Conditioning on Ischemia and Reperfusion Injury in Patients Submitted to Coronary Artery Bypass Grafting.
This study evaluates the addition of remote ischemic preconditioning and postconditioning to standard myocardial protection protocol in patients submitted to off - pump coronary artery bypass grafting in a prospective, 1:1 randomized, double blind fashion. An interventional group will receive remote ischemic preconditioning 24-hours before OP-CABG, immediately before surgery and within 60 minutes following surgery by means of lower limb ischemia achieved by pressure cuff inflation, whereas control group will receive sham procedure perioperatively.
Read the detailed description
In a prospective, 1:1 randomized and double blind fashion, the study will evaluate the impact of remote ischemic preconditioning, both immediate and second window of protection (24 hours and immediately before surgery) with remote ischemic postconditiong on operative outcomes in patients submitted to coronary artery bypass grafting without use of extracorporeal circulation.
Remote ischemic conditioning was found to provide protection against necrosis and apoptosis due to ischemia and reperfusion injury, a phenomenon observed during coronary artery bypass grafting. That in turn was associated with poor postoperative outcomes, predominantly poor survival.
Remote ischemic preconditioning will be provided by repeated lower leg ischemia and reperfusion with pressure cuff inflation for five minutes and deflation for five minutes in three consecutive cycles. Remote ischemic preconditioning will be performed 24 hours before CABG and immediately before surgery. Remote ischemic postconditioning will be performed within 60 minutes following the last coronary artery bypass graft completion and the restoration of coronary blood flow.
The study will assess clinical endpoints such as postoperative acute myocardial infarction (type 5 MI), postoperative mortality, postoperative renal failure and laboratory outcomes such as postoperative serial measurements of troponin T release or glomerular filtration rate as secondary outcomes.
- Conditions
- Coronary Artery Bypass, Myocardial Reperfusion Injur, Ischemic Preconditioning, Myocardial, Ischemic Postconditioning
- Being tested
- Remote Ischemic Preconditioning with Postconditioning, Sham RIPC procedure
- Keywords
- myocardial protection, remote ischemic preconditioning, remote ischemic postconditioning, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Preconditioning with PostconditioningProcedure or surgery
Three cycles of 5 minutes of ischemia and 5 minutes of reperfusion of lower leg 24 hours, immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively.
Sham RIPC procedureProcedure or surgery
Three cycles of 5 minutes of inflation and 5 minutes of deflation of artificial lower leg immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| RIC Group | Experimental | Three cycles of remote ischemic conditioning (5minutes ischemia and 5minutes reperfusion; lower leg ischemia achieved by pressure cuff inflation and deflation); First three cycles the patient will receive 24 hours preoperatively, second three cycles the patient will receive after the induction of general anesthesia but before skin incision shortly before CABG. Remote ischemic postconditioning (5minutes ischemia and 5minutes reperfusion; lower leg ischemia achieved by pressure cuff inflation and deflation) will be administered to the patient within 60 minutes after the completion of all coronary artery bypass grafts and the restoration of coronary blood flow. Receives: Procedure: Remote Ischemic Preconditioning with Postconditioning |
| Control Group | Sham comparator | Control group will receive sham procedure near identical to intervention. That will be afforded by inflation of pressure cuff on artificial leg hidden under the draping by an assistant who is not included in the research team and does not have any connection to study design and data analysis. Receives: Procedure: Sham RIPC procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative myocardial necrosis
Serial mesurements of High - Sensitive Troponin T release
Measured: 72 hours postoperatively
Postoperative kidney injury
Serial measurements of estimated glomerular filtration rate by creatinine
Measured: 7 days postoperatively
Secondary outcomes (3)
Perioperative mortality
30-day all cause mortality
Measured: 30 days postoperatively
Perioperative myocardial infarction
30-day myocardial infarction
Measured: 30 days postoperatively
Postoperative Acute Kidney Injury
Prevalence of acute kidney injury according to Society of Thoracic Surgeons definitions of outcomes.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Jan 2014
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2020 (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 Coronary Artery BypassStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medinet Heart Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakub S. Marczak, M.D., Principal investigator, Medinet Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363958
- Sponsor's protocol ID
- RIPC Trial
- Acronym
- RICARDO
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marczak J, Nowicki R, Kulbacka J, Saczko J. Is remote ischaemic preconditioning of benefit to patients undergoing cardiac surgery? Interact Cardiovasc Thorac Surg. 2012 May;14(5):634-9. doi: 10.1093/icvts/ivr123. Epub 2012 Jan 26.
PubMed 22286602
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Conditioning on Ischemia and Reperfusion Injury in Patients Submitted to Coronary Artery Bypass Grafting.
- ClinicalTrials.gov ID
- NCT03363958
- Acronym / sponsor ID
- RICARDO / RIPC Trial
- Conditions
- Coronary Artery Bypass, Myocardial Reperfusion Injur, Ischemic Preconditioning, Myocardial, Ischemic Postconditioning
- Keywords
- myocardial protection, remote ischemic preconditioning, remote ischemic postconditioning, cardiac surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medinet Heart CentreUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 6 Dec 2017 (actual)
- 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.
This study evaluates the addition of remote ischemic preconditioning and postconditioning to standard myocardial protection protocol in patients submitted to off - pump coronary artery bypass grafting in a prospective, 1:1 randomized, double blind fashion. An interventional group will receive remote ischemic preconditioning 24-hours before OP-CABG, immediately before surgery and within 60 minutes following surgery by means of lower limb ischemia achieved by pressure cuff inflation, whereas control group will receive sham procedure perioperatively.
Detailed description
In a prospective, 1:1 randomized and double blind fashion, the study will evaluate the impact of remote ischemic preconditioning, both immediate and second window of protection (24 hours and immediately before surgery) with remote ischemic postconditiong on operative outcomes in patients submitted to coronary artery bypass grafting without use of extracorporeal circulation.
Remote ischemic conditioning was found to provide protection against necrosis and apoptosis due to ischemia and reperfusion injury, a phenomenon observed during coronary artery bypass grafting. That in turn was associated with poor postoperative outcomes, predominantly poor survival.
Remote ischemic preconditioning will be provided by repeated lower leg ischemia and reperfusion with pressure cuff inflation for five minutes and deflation for five minutes in three consecutive cycles. Remote ischemic preconditioning will be performed 24 hours before CABG and immediately before surgery. Remote ischemic postconditioning will be performed within 60 minutes following the last coronary artery bypass graft completion and the restoration of coronary blood flow.
The study will assess clinical endpoints such as postoperative acute myocardial infarction (type 5 MI), postoperative mortality, postoperative renal failure and laboratory outcomes such as postoperative serial measurements of troponin T release or glomerular filtration rate as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC Group | Experimental | Procedure: Remote Ischemic Preconditioning with PostconditioningThree cycles of remote ischemic conditioning (5minutes ischemia and 5minutes reperfusion; lower leg ischemia achieved by pressure cuff inflation and deflation); First three cycles the patient will receive 24 hours preoperatively, second three cycles the patient will receive after the induction of general anesthesia but before skin incision shortly before CABG. Remote ischemic postconditioning (5minutes ischemia and 5minutes reperfusion; lower leg ischemia achieved by pressure cuff inflation and deflation) will be administered to the patient within 60 minutes after the completion of all coronary artery bypass grafts and the restoration of coronary blood flow. |
| Control Group | Sham comparator | Procedure: Sham RIPC procedureControl group will receive sham procedure near identical to intervention. That will be afforded by inflation of pressure cuff on artificial leg hidden under the draping by an assistant who is not included in the research team and does not have any connection to study design and data analysis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients qualified to coronary artery bypass grafting according to ESC/EACTS Guidelines of myocardial revascularization, suffering from:
- Multivessel coronary artery disease amenable for surgical treatment
- Negative history of previous cardiac or vascular surgery in childhood and afterwards.
- Negative history of active neoplastic disease, neither past medical history of oncological treatment
- Patients with non insulin dependent diabetes mellitus treated chronically with oral derivatives of sulfonylourea such as but not limited to: glibenclamide.
Key exclusion criteria (5 listed)
- Patients suffering from acute insuficiency of any organ/ system and those suffering from end stage organ failure such as:
- Chronic renal disease - KDOQI stage ≥ 3;
- Chronic renal failure class A by Child - Pugh'a;
- Chronic respiratory failure (type I and II according to Campbell et al. and type I according to Wood et al.);
- Chronic intermittent claudication class 2A according to Fontaine;
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 with PostconditioningThree cycles of 5 minutes of ischemia and 5 minutes of reperfusion of lower leg 24 hours, immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively. | Procedure or surgery | RIC Group |
| Sham RIPC procedureThree cycles of 5 minutes of inflation and 5 minutes of deflation of artificial lower leg immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively. | Procedure or surgery | Control Group |
Primary outcome
Postoperative myocardial necrosis
Time frame: 72 hours postoperatively
Serial mesurements of High - Sensitive Troponin T release
Postoperative kidney injury
Time frame: 7 days postoperatively
Serial measurements of estimated glomerular filtration rate by creatinine
3 secondary outcomes
Perioperative mortality
Time frame: 30 days postoperatively
Perioperative myocardial infarction
Time frame: 30 days postoperatively
Postoperative Acute Kidney Injury
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Background: PubMed 22286602Marczak J, Nowicki R, Kulbacka J, Saczko J. Is remote ischaemic preconditioning of benefit to patients undergoing cardiac surgery? Interact Cardiovasc Thorac Surg. 2012 May;14(5):634-9. doi: 10.1093/icvts/ivr123. Epub 2012 Jan 26.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Coronary Artery Bypass Graft (CABG)
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.
Jakub S. Marczak, M.D. principal investigator
Medinet Heart Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remote Ischemic Preconditioning with Postconditioning in people with Coronary Artery Bypass and Myocardial Reperfusion Injur, run by Medinet Heart Centre at 1 site in Poland.
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 5 inclusion and 5 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 Dec 2017. 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 Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jakub S. Marczak, M.D. (0048883774566, marczak@space.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative myocardial necrosis (time frame: 72 hours postoperatively). The study lists 2 primary outcomes in all. 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 NCT03363958, 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 Dec 2017.