Myocardial Protection Clinical Trial
Official title:
Comparison of Blood Cardioplegia and Custodiol on Patients Operated for Significant Mitral Valve Innsufisiens. An Prospective, Randomized Two-center Study.
Verified date | September 2013 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Thru the last 20 years it has been a discussion witch solution that gives the best myocardial
protection during cardiac arrest by heart operations.
- It has been a tendency that a blood based cardioplegia gives a better protection bye
long ischemic times but it has not been possible too conclude in this matter.
- The investigators have two groups of cardioplegia, the blood based and, the crystalloid
based cardioplegia.
- It has been done a lot of studies to see what kind of cardioplegia that gives the best
myocardial protection. Different temperature, different amount and content, retrograde
or antegrade or both, contentiously and further on have been tested without a clear
conclusion.
- The investigators decided to make a study with a cohort of patients as homogenous as
possible with a cross clamp time around 70 min.
- Adult patients' with a severe aortic stenoses without any other significant heart
disease was included in our prospective randomised study.
- Patients with additional significant coronary artery disease (≥ 50% stenoses) were
excluded from the study.
- The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the
myocardial damage.
Status | Completed |
Enrollment | 76 |
Est. completion date | January 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
The study protocol was approved by the local ethical committees. Eligible for operation
were: Inclution Criteria - patients with mitral regurgitation equal to or larger than grade 3 out of 4. - Ablation for atrial fibrillation was the only concomitant procedure that was allowed in addition to mitral valve surgery and these patients were block-randomized to ensure equally many patients with ablation in the two groups of cardioplegia. Exclusion Criteria - Patients with any other concomitant heart valve disease or coronary artery stenoses (= 50%) were excluded from the study. - Age below 18 - Pregnant |
Country | Name | City | State |
---|---|---|---|
Norway | thoraxkirurgisk avd, UUS | Oslo |
Lead Sponsor | Collaborator |
---|---|
Ullevaal University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CK-MB ,troponin-T | 72 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00546390 -
Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study
|
N/A | |
Completed |
NCT01941420 -
Comparison of Blood and Crystalloid Cardioplegia
|
N/A | |
Completed |
NCT03859115 -
Effects of TENS on Myocardial Protection in Patients Undergoing AVR
|
N/A | |
Completed |
NCT04231903 -
Myocardial Protection in Minimally Invasive Mitral Valve Surgery
|
||
Completed |
NCT06287372 -
Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegia
|
||
Not yet recruiting |
NCT03595111 -
Myocardial Biopsy in Congenital Cardiac Surgery
|
N/A | |
Completed |
NCT00610350 -
Levosimendan and Myocardial Protection
|
Phase 4 |