Ischaemia-reperfusion InjuryPhase 3NCT01771978
Ischaemia-réperfusion During the Coronary Surgery With Beating Heart
A Phase 3 study testing Diltiazem, Acetylcystein and diltiazem and acetylcystein in people with Ischaemia-reperfusion Injury, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Ischaemia-reperfusion Injury
- What is being tested?
- Diltiazem, Acetylcystein and diltiazem and acetylcystein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2002to Feb 2008
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age included between 60 and 80 years
Who cannot join
- Age < 60 or > 80 years
- Pregnancy
- The allergy in used medicines (N-acétylcystéine, Diltiazem)
- Presence of a pathology valvulaire associated
- Urgency
- Unstable angor
Show all 11Show fewer
- Bypass as a matter of urgency
- Recours peropératoire to a CEC
- FE < 0,40
- BAV of the 2nd and 3rd not sailed degree
- fibrillation or flutter little finger.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Diltiazem and/or N-Acétylcystéine Versus Placebo on hémodynamiques and Biological Repercussions of the Ischaemia-réperfusion During the Coronary Surgery With Beating Heart
Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.
- Conditions
- Ischaemia-reperfusion Injury
- Being tested
- Placebo, Diltiazem, Acetylcystein, diltiazem and acetylcystein
- Keywords
- ischaemia-reperfusion injury, cardiac surgery, oxidative stress markers, troponin, diltiazem, acetylcystein
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called placebo group
Received 250 ml of a 5% dextrose solution as placebo
DiltiazemDrug
Also called Diltiazem group
Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
AcetylcysteinDrug
Also called Acetylcystein group
Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
diltiazem and acetylcysteinDrug
Also called Combined diltiazem and acetylcystein drug group
Received a combination of drug :diltiazem and acetylcystein
- bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution
- 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution
| Study group | Role | What they receive |
|---|---|---|
| Arm1: control group | Placebo comparator | Received 250 ml of a 5% dextrose solution as placebo drug Receives: Drug: Placebo |
| Arm 2: diltiazem group | Experimental | Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution Receives: Drug: Diltiazem |
| Arm 3: acetylcystein group | Experimental | Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution Receives: Drug: Acetylcystein |
| Arm 4: diltiazem and acetylcystein group | Experimental | Received a combination of drug :
bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution and 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution Receives: Drug: diltiazem and acetylcystein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine
Choosing as main biological variable rate cTnI cardiospecific, above the threshold of detection (0.3 mcg / L) in 40% of patients operated on a beating heart hoping to reduce this percentage to 10% as a result of treatment with diltiazem and N-acetylcysteine
Measured: during ischaemia-reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJun 2002
- Primary completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemia-reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annick Steib, MD, PhD, Study director, Strasbourg University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771978
- Sponsor's protocol ID
- 2276
- Status last verified
- Feb 2008
- First submitted
- 27 Dec 2012
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diltiazem and/or N-Acétylcystéine Versus Placebo on hémodynamiques and Biological Repercussions of the Ischaemia-réperfusion During the Coronary Surgery With Beating Heart
- ClinicalTrials.gov ID
- NCT01771978
- Acronym / sponsor ID
- 2276
- Conditions
- Ischaemia-reperfusion Injury
- Keywords
- ischaemia-reperfusion injury, cardiac surgery, oxidative stress markers, troponin, diltiazem, acetylcystein
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Feb 2008 (actual)
- First posted
- 18 Jan 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.
Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm1: control group | Placebo comparator | Drug: PlaceboReceived 250 ml of a 5% dextrose solution as placebo drug |
| Arm 2: diltiazem group | Experimental | Drug: DiltiazemReceived a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution |
| Arm 3: acetylcystein group | Experimental | Drug: AcetylcysteinReceived 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution |
| Arm 4: diltiazem and acetylcystein group | Experimental | Drug: diltiazem and acetylcysteinReceived a combination of drug : bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution and 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age included between 60 and 80 years
Key exclusion criteria (11 listed)
- Age < 60 or > 80 years
- Pregnancy
- The allergy in used medicines (N-acétylcystéine, Diltiazem)
- Presence of a pathology valvulaire associated
- Urgency
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 |
|---|---|---|
| PlaceboAlso: placebo groupReceived 250 ml of a 5% dextrose solution as placebo | Drug | Arm1: control group |
| DiltiazemAlso: Diltiazem groupReceived a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution | Drug | Arm 2: diltiazem group |
| AcetylcysteinAlso: Acetylcystein groupReceived 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution | Drug | Arm 3: acetylcystein group |
| diltiazem and acetylcysteinAlso: Combined diltiazem and acetylcystein drug groupReceived a combination of drug :diltiazem and acetylcystein * bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution * 150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution | Drug | Arm 4: diltiazem and acetylcystein group |
Primary outcome
Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine
Time frame: during ischaemia-reperfusion
Choosing as main biological variable rate cTnI cardiospecific, above the threshold of detection (0.3 mcg / L) in 40% of patients operated on a beating heart hoping to reduce this percentage to 10% as a result of treatment with diltiazem and N-acetylcysteine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
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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.
Annick Steib, MD, PhD study director
Strasbourg University Hospital, France
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 Diltiazem, Acetylcystein and diltiazem and acetylcystein in people with Ischaemia-reperfusion Injury, run by University Hospital, Strasbourg, France 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 1 inclusion and 11 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 18 Jan 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 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. 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 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?
Results are not available in the source record.
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?
Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine (time frame: during ischaemia-reperfusion). 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 Jan 2013.