Mitral InsufficienciesNCT01941459
Comparison of Blood Cardioplegia and Custodiol
An observational study of Mitral Insufficiencies and Myocardial Protection, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
Thru the last 20 years it has been a discussion witch solution that gives the best myocardial protection during cardiac arrest by heart operations. It has been a tendency that a blood based cardioplegia gives a better protection bye long ischemic times but it has not been possible too conclude in this matter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Insufficiencies, Myocardial Protection
- How many people
- 76 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2007to Jan 2010
- Phase
- Observational
- 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
Study population: Between Mars 2007 and December 2009, 80 consecutive patients undergoing elective mitral valve surgery for mitral regurgitation at Oslo University Hospital Ullevål, Oslo, Norway and Sahlgrenska University Hospital, Gothenburg, Sweden were included in the study after informed written consent.
Who may be able to join
None listed.
Who cannot join
- Patients with any other concomitant heart valve disease or coronary artery stenoses (≥ 50%) were excluded from the study.
- Age below 18
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Blood Cardioplegia and Custodiol on Patients Operated for Significant Mitral Valve Innsufisiens. An Prospective, Randomized Two-center Study.
Thru the last 20 years it has been a discussion witch solution that gives the best myocardial protection during cardiac arrest by heart operations.
- It has been a tendency that a blood based cardioplegia gives a better protection bye long ischemic times but it has not been possible too conclude in this matter.
- The investigators have two groups of cardioplegia, the blood based and, the crystalloid based cardioplegia.
- It has been done a lot of studies to see what kind of cardioplegia that gives the best myocardial protection. Different temperature, different amount and content, retrograde or antegrade or both, contentiously and further on have been tested without a clear conclusion.
- The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min.
- Adult patients' with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study.
- Patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.
- The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the myocardial damage.
Read the detailed description
Objective: Myocardial protection during a cardiac arrest is mostly managed with cardioplegia. To day we normally used a blood or crystalloid based solutions. It has been published a lot of papers comparing the too groups with different results. To our knowledge no prospective, randomized study has compared modified St Thomas based Blood and Crystalloid cardioplegia on the acknowledged markers (CK-MB, troponin-T) of myocardial damage during aortic valve replacement on patients without additional significant coronary artery disease.
Methods: 100 patients with aorta stenoses undergoing aortic valve replacement without significant coronary artery stenoses or other significant concomitant heart valve disease were included in the study. They were given antegrade cold blood or cold crystalloid cardioplegia delivered through the coronary Ostia every 20 min throughout the period of aortic cross-clamp. CK-MB and troponin-T were compared between the two groups.
Published 2010 in the journal of thoracic and cardiovascular surgery.
- Conditions
- Mitral Insufficiencies, Myocardial Protection
- Keywords
- CK-MB, troponin-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 Custodiol | Custodiol | |
| 2 Blood cardioplegia | Blood cardioplegia |
What is being measured
The primary outcome is the main question the study is designed to answer.
CK-MB ,troponin-T
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startMar 2007
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral InsufficienciesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjørn Braathen, Oslo University Hospital
- Investigators
- Theis Tønnessen, prof.dr.med, Study director, Thoraxkirurgisk avd. UUSBjørn Braathen, med.doc, Study chair, Thoraxkir.avd. UUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941459
- Sponsor's protocol ID
- 2007-001780-30
- Status last verified
- Sep 2013
- First submitted
- 7 May 2012
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Cardioplegia and Custodiol on Patients Operated for Significant Mitral Valve Innsufisiens. An Prospective, Randomized Two-center Study.
- ClinicalTrials.gov ID
- NCT01941459
- Acronym / sponsor ID
- 2007-001780-30
- Conditions
- Mitral Insufficiencies, Myocardial Protection
- Keywords
- CK-MB, troponin-T
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Sep 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.
Thru the last 20 years it has been a discussion witch solution that gives the best myocardial protection during cardiac arrest by heart operations.
- It has been a tendency that a blood based cardioplegia gives a better protection bye long ischemic times but it has not been possible too conclude in this matter.
- The investigators have two groups of cardioplegia, the blood based and, the crystalloid based cardioplegia.
- It has been done a lot of studies to see what kind of cardioplegia that gives the best myocardial protection. Different temperature, different amount and content, retrograde or antegrade or both, contentiously and further on have been tested without a clear conclusion.
- The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min.
- Adult patients' with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study.
- Patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.
- The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the myocardial damage.
Detailed description
Objective: Myocardial protection during a cardiac arrest is mostly managed with cardioplegia. To day we normally used a blood or crystalloid based solutions. It has been published a lot of papers comparing the too groups with different results. To our knowledge no prospective, randomized study has compared modified St Thomas based Blood and Crystalloid cardioplegia on the acknowledged markers (CK-MB, troponin-T) of myocardial damage during aortic valve replacement on patients without additional significant coronary artery disease.
Methods: 100 patients with aorta stenoses undergoing aortic valve replacement without significant coronary artery stenoses or other significant concomitant heart valve disease were included in the study. They were given antegrade cold blood or cold crystalloid cardioplegia delivered through the coronary Ostia every 20 min throughout the period of aortic cross-clamp. CK-MB and troponin-T were compared between the two groups.
Published 2010 in the journal of thoracic and cardiovascular surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Custodiol | – | –Custodiol |
| 2 Blood cardioplegia | – | –Blood cardioplegia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between Mars 2007 and December 2009, 80 consecutive patients undergoing elective mitral valve surgery for mitral regurgitation at Oslo University Hospital Ullevål, Oslo, Norway and Sahlgrenska University Hospital, Gothenburg, Sweden were included in the study after informed written consent.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients with any other concomitant heart valve disease or coronary artery stenoses (≥ 50%) were excluded from the study.
- Age below 18
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CK-MB ,troponin-T
Time frame: 72 hours
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 13 Sep 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.
Theis Tønnessen, prof.dr.med study director
Thoraxkirurgisk avd. UUS
Bjørn Braathen, med.doc study chair
Thoraxkir.avd. UUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Insufficiencies and Myocardial Protection, run by Ullevaal University Hospital at 1 site in Norway.
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 0 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 13 Sep 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 Norway. 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.
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?
CK-MB ,troponin-T (time frame: 72 hours). 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 13 Sep 2013; AzTrials last refreshed its copy on 7 Nov 2026.