Cardiomyocyte ApoptosisNCT01185912
Cardiomyocyte Apoptosis Following Antegrade and Retrograde Cardioplegia
An observational study of Cardiomyocyte Apoptosis, run by Turku University Hospital at 1 site in Finland.
Trial summary
Retrograde cardioplegia during heart surgery is associated with inadequate myocardial protection. In experimental animal study retrograde cardioplegia induces more cardiomyocyte apoptosis when compared to antegrade cardioplegia. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Cardiomyocyte Apoptosis
- What is being tested?
- Ventricle muscle tissue samples
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2008to 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients (male and female) undergoing elective aortic valve replacement surgery due to aortic valve stenosis or combined aortic valve disease in Turku University Hospital, Department of Surgery.
Who may be able to join
- aortic valve stenosis or combined aortic valve disease
Who cannot join
- angiographically verified hemodynamically significant coronary artery disease impaired left ventricular function (left ventricular ejection fraction <50%) surgery including additional procedures other than aortic valve replacement cancer
Trial locations and contacts
1 site in 1 country.
About this study
Retrograde cardioplegia during heart surgery is associated with inadequate myocardial protection. In experimental animal study retrograde cardioplegia induces more cardiomyocyte apoptosis when compared to antegrade cardioplegia. 20 volunteer patients under going elective aortic valve surgery will be divided in to two groups: 10 patients receiving only antegrade cardioplegia and 10 patients receiving only retrograde cardioplegia. Pre- and post-operatively cardiac MRI and cardiac ultrasound will be performed. During the surgery ventricular muscle samples will be taken in order to assess cardiomyocyte apoptosis. Aims of the study: 1. whether the cardiomyocyte apoptosis is significantly more induced after retrograde cardioplegia than antegrade cardioplegia, 2. whether the amount of apoptotic cardiomyocytes correlates to conventional markers of myocardial injury after cardiac surgery, 3. whether the extent of irreversible myocardial damage by apoptosis correlates to post-ischemic contractile dysfunction after cardiac surgery, as measured with echocardiography, 4. whether the amount of cardiomyocyte apoptosis correlates to long term outcome and cardiac function as measured with MRI.
- Conditions
- Cardiomyocyte Apoptosis
- Being tested
- Ventricle muscle tissue samples
- Keywords
- Cardiac MRI, Cardiac ultrasound, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventricle muscle tissue samplesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cardiomyocyte apoptosis | Elective aortic valve replacement patience Receives: Procedure: Ventricle muscle tissue samples |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyocyte ApoptosisStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Finnish Foundation for Cardiovascular Research
- Responsible party
- Principal investigator, Markus Malmberg, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185912
- Sponsor's protocol ID
- 1/2006
- Status last verified
- May 2015
- First submitted
- 24 Jun 2010
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiomyocyte Apoptosis Following Antegrade and Retrograde Cardioplegia
- ClinicalTrials.gov ID
- NCT01185912
- Acronym / sponsor ID
- 1/2006
- Conditions
- Cardiomyocyte Apoptosis
- Keywords
- Cardiac MRI, Cardiac ultrasound, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Finnish Foundation for Cardiovascular Research
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Aug 2010 (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.
Retrograde cardioplegia during heart surgery is associated with inadequate myocardial protection. In experimental animal study retrograde cardioplegia induces more cardiomyocyte apoptosis when compared to antegrade cardioplegia. 20 volunteer patients under going elective aortic valve surgery will be divided in to two groups: 10 patients receiving only antegrade cardioplegia and 10 patients receiving only retrograde cardioplegia. Pre- and post-operatively cardiac MRI and cardiac ultrasound will be performed. During the surgery ventricular muscle samples will be taken in order to assess cardiomyocyte apoptosis. Aims of the study: 1. whether the cardiomyocyte apoptosis is significantly more induced after retrograde cardioplegia than antegrade cardioplegia, 2. whether the amount of apoptotic cardiomyocytes correlates to conventional markers of myocardial injury after cardiac surgery, 3. whether the extent of irreversible myocardial damage by apoptosis correlates to post-ischemic contractile dysfunction after cardiac surgery, as measured with echocardiography, 4. whether the amount of cardiomyocyte apoptosis correlates to long term outcome and cardiac function as measured with MRI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiomyocyte apoptosis | – | Procedure: Ventricle muscle tissue samplesElective aortic valve replacement patience |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients (male and female) undergoing elective aortic valve replacement surgery due to aortic valve stenosis or combined aortic valve disease in Turku University Hospital, Department of Surgery.
Key inclusion criteria (1 listed)
- aortic valve stenosis or combined aortic valve disease
Key exclusion criteria (1 listed)
- angiographically verified hemodynamically significant coronary artery disease impaired left ventricular function (left ventricular ejection fraction <50%) surgery including additional procedures other than aortic valve replacement cancer
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 |
|---|---|---|
| Ventricle muscle tissue samples | Procedure or surgery | Cardiomyocyte apoptosis |
Primary outcome
Not reported in the source record.
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 20 May 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiomyocyte Apoptosis, run by Turku University Hospital at 1 site in Finland.
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 1 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 20 May 2015. 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 Finland. 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.
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 20 May 2015.