Cardiomyocyte Apoptosis Following Antegrade and Retrograde Cardioplegia

NCT ID: NCT01185912

Last Updated: 2015-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiomyocyte Apoptosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiomyocyte apoptosis

Elective aortic valve replacement patience

Ventricle muscle tissue samples

Intervention Type PROCEDURE

Interventions

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Ventricle muscle tissue samples

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Finnish Foundation for Cardiovascular Research

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Markus Malmberg

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Turku University Hospital, Department of Surgery

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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1/2006

Identifier Type: -

Identifier Source: org_study_id

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