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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01185912
Other study ID # 1/2006
Secondary ID
Status Completed
Phase N/A
First received June 24, 2010
Last updated May 19, 2015
Start date January 2008
Est. completion date January 2010

Study information

Verified date May 2015
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 90 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Ventricle muscle tissue samples


Locations

Country Name City State
Finland Turku University Hospital, Department of Surgery Turku

Sponsors (2)

Lead Sponsor Collaborator
Turku University Hospital Finnish Foundation for Cardiovascular Research

Country where clinical trial is conducted

Finland, 

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