NCT01185912

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

June 24, 2010

Last Update Submit

May 19, 2015

Conditions

Keywords

Cardiac MRICardiac ultrasoundCardiac surgery

Study Arms (1)

Cardiomyocyte apoptosis

Elective aortic valve replacement patience

Procedure: Ventricle muscle tissue samples

Interventions

Cardiomyocyte apoptosis

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

Locations