- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01185912
Cardiomyocyte Apoptosis Following Antegrade and Retrograde Cardioplegia
May 19, 2015 updated by: Markus Malmberg, Turku University Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Turku, Finland, 20521
- Turku University Hospital, Department of Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- aortic valve stenosis or combined aortic valve disease
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cardiomyocyte apoptosis
Elective aortic valve replacement patience
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
January 1, 2010
Study Completion (ACTUAL)
January 1, 2010
Study Registration Dates
First Submitted
June 24, 2010
First Submitted That Met QC Criteria
August 19, 2010
First Posted (ESTIMATE)
August 20, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
May 20, 2015
Last Update Submitted That Met QC Criteria
May 19, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1/2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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