Coronary Artery StenosisPhase 3CardioplégieNCT01401140
Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis
A Phase 3 study testing St Thomas and Custodiol in people with Coronary Artery Stenosis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- St Thomas and Custodiol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Mar 2012
- Phase
- Phase 3
- 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
- Patient was referred to the Cardiovascular Surgery Unit for surgical coronary revascularization
- Patient has anterior interventricular stenosis
- Patient signed the informed consent form
- Patient is covered by health insurance
Who cannot join
- Patients with beating heart surgery indication (no extracorporeal circulation required)
- Emergency surgery and patients who suffered myocardial infarction less than a week before surgery
- Iterative surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary Surgery: Comparing the Protective Effects of Two Cardioplegic Solutions: Custodiol Versus St Thomas, on Cardiac Metabolism, as Assessed Using Microdialysis
An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue.
High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.
Read the detailed description
Myocardial microdialysis is the state-of-the-art technique for evaluating the protective effects of cardioplegic solutions; it enables physicians to monitor oxidation-reduction muscle metabolism during an ongoing operation.
- Conditions
- Coronary Artery Stenosis
- Being tested
- St Thomas, Custodiol
- Keywords
- Coronary Artery Bypass, Coronary Artery Surgery, Coronary Artery Bypass Graft, Coronary Revascularization, Cardiac microdialysis, Custodiol, St Thomas, Cardioplegic solutions
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St ThomasDrug
Also called St Thomas solution or SLF 103 (Aguettant)
Once the upper aorta has been clamped, the cardioplegic solution St Thomas will be administered directly into it via an anterograde approach. St Thomas will be infused every 30 minutes at a dosage of 10ml/kg bodyweight (infusion takes about three minutes). If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped.
CustodiolDrug
Also called Custodiol (Eusa Pharma)
Once the upper aorta has been clamped, the cardioplegic solution Custodiol will be administered directly into it via an anterograde approach. Custodiol will be injected in one bolus (20 ml/kg), which takes eight minutes. If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped.
| Study group | Role | What they receive |
|---|---|---|
| St Thomas | Active comparator | Not described Receives: Drug: St Thomas |
| Custodiol | Experimental | Not described Receives: Drug: Custodiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate concentrations per-operatory
Mean interstitial lactate concentrations (lactate peak and lactate/pyruvate ratio) observed between the beginning of surgery, and declamping in each patient group (St Thomas cardioplegia group vs Custodiol cardioplegia group)
Measured: Every 10 minutes between the beginning of surgery, and declamping (per-operatory)
Secondary outcomes (2)
Anoxic variations 24h
Interstitial lactate and pyruvate concentrations, lactate/pyruvate ratio, and glycerol concentration (glycerol is a marker of cell membrane damage),
Measured: Every hours after end of surgery and until the 24th hour following declamping.
Drug consumption
Inotropic drug consumption (dobutamin, noradrenalin, adrenalin) during the first 72 hours following declamping
Measured: At 72 hours after declamping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals, Association AIRE (FR)
- Responsible party
- Sponsor
- Investigators
- Marco VOLA, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401140
- Sponsor's protocol ID
- 0908033
- Other IDs
- 2009-A00506-51
- Acronym
- Cardioplégie
- Status last verified
- Mar 2012
- First submitted
- 20 Jul 2011
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Surgery: Comparing the Protective Effects of Two Cardioplegic Solutions: Custodiol Versus St Thomas, on Cardiac Metabolism, as Assessed Using Microdialysis
- ClinicalTrials.gov ID
- NCT01401140
- Acronym / sponsor ID
- Cardioplégie / 0908033
- Conditions
- Coronary Artery Stenosis
- Keywords
- Coronary Artery Bypass, Coronary Artery Surgery, Coronary Artery Bypass Graft, Coronary Revascularization, Cardiac microdialysis, Custodiol, St Thomas, Cardioplegic solutions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals, Association AIRE (FR)
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Jul 2011 (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.
An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue.
High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.
Detailed description
Myocardial microdialysis is the state-of-the-art technique for evaluating the protective effects of cardioplegic solutions; it enables physicians to monitor oxidation-reduction muscle metabolism during an ongoing operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| St Thomas | Active comparator | Drug: St Thomas |
| Custodiol | Experimental | Drug: Custodiol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient was referred to the Cardiovascular Surgery Unit for surgical coronary revascularization
- Patient has anterior interventricular stenosis
- Patient signed the informed consent form
- Patient is covered by health insurance
Key exclusion criteria (3 listed)
- Patients with beating heart surgery indication (no extracorporeal circulation required)
- Emergency surgery and patients who suffered myocardial infarction less than a week before surgery
- Iterative 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 |
|---|---|---|
| St ThomasAlso: St Thomas solution or SLF 103 (Aguettant)Once the upper aorta has been clamped, the cardioplegic solution St Thomas will be administered directly into it via an anterograde approach. St Thomas will be infused every 30 minutes at a dosage of 10ml/kg bodyweight (infusion takes about three minutes). If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped. | Drug | St Thomas |
| CustodiolAlso: Custodiol (Eusa Pharma)Once the upper aorta has been clamped, the cardioplegic solution Custodiol will be administered directly into it via an anterograde approach. Custodiol will be injected in one bolus (20 ml/kg), which takes eight minutes. If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped. | Drug | Custodiol |
Primary outcome
Lactate concentrations per-operatory
Time frame: Every 10 minutes between the beginning of surgery, and declamping (per-operatory)
Mean interstitial lactate concentrations (lactate peak and lactate/pyruvate ratio) observed between the beginning of surgery, and declamping in each patient group (St Thomas cardioplegia group vs Custodiol cardioplegia group)
2 secondary outcomes
Anoxic variations 24h
Time frame: Every hours after end of surgery and until the 24th hour following declamping.
Drug consumption
Time frame: At 72 hours after declamping
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 19 Mar 2012.
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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.
Marco VOLA, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing St Thomas and Custodiol in people with Coronary Artery Stenosis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 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 19 Mar 2012. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Lactate concentrations per-operatory (time frame: Every 10 minutes between the beginning of surgery, and declamping (per-operatory)). 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 19 Mar 2012.