Cardiomyocyte Apoptosis Following Antegrade and Retrograde Cardioplegia
1 other identifier
observational
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 24, 2010
CompletedFirst Posted
Study publicly available on registry
August 20, 2010
CompletedMay 20, 2015
May 1, 2015
2 years
June 24, 2010
May 19, 2015
Conditions
Keywords
Study Arms (1)
Cardiomyocyte apoptosis
Elective aortic valve replacement patience
Interventions
Eligibility Criteria
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.
You may qualify if:
- aortic valve stenosis or combined aortic valve disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Turku University Hospital, Department of Surgery
Turku, 20521, Finland
Biospecimen
Transmyocardial needle biopsies
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 24, 2010
First Posted
August 20, 2010
Study Start
January 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
May 20, 2015
Record last verified: 2015-05