Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass
3 other identifiers
interventional
369
1 country
1
Brief Summary
Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. The investigators recent found simvastatin reduced myocardial injury during noncoronary artery cardiac surgery in single medical center. The investigators further investigate that whether simvastatin can protect myocardium during noncoronary artery cardiac surgery with cardiopulmonary bypass and improve cardiac function with long term use postoperatively in two medical centers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 26, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedApril 21, 2023
April 1, 2023
11.9 years
July 26, 2012
April 19, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
troponin
The investigator will measure the plasma troponin level in several time points before and after surgery in each patient. This is mainly for the comparason between control and short statin, which has been proved in our previous clinical trial: statin1.
within the first 7 days after surgery
ejection fraction
Each patient will be followed up and checked with B ultrasound on heart in 1,3,6,12,18 and 24 months after surgery. The ejection fraction will be measured. This is mainly for the comparason between short statin and long statin, which is the major goal in this clinical trial: statin 2.
within two years
Secondary Outcomes (1)
long term survival
within two years
Study Arms (3)
control
NO INTERVENTIONuntreated
short statin
EXPERIMENTALSimvastatin (20 mg) was administered every day for the 5-7 days preoperatively, but not the day of surgery in the statin group. Then simvastatin was re-administered at the second day until 7 days postoperatively.
long statin
EXPERIMENTALSimvastatin (20 mg) was administered every day for the 5-7 days preoperatively, but not the day of surgery in the statin group. Then simvastatin was re-administered at the second day until 6 months postoperatively.
Interventions
In short statin group: 20 mg per day, start at 5-7 days before surgery and continue for 7 days. In long statin group: 20 mg per day, start at 5-7 days before surgery and continue for 6 months.
Eligibility Criteria
You may qualify if:
- More than 18-year-old,
- Congenital heart disease(not complex),
- Isolated heart valve disease,
You may not qualify if:
- Coronary artery disease
- Allergy for statins
- Poor liver function,Hepatitis
- Gestation women and Breast-feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Related Publications (1)
Marques Antunes M, Nunes-Ferreira A, Duarte GS, Gouveia E Melo R, Sucena Rodrigues B, Guerra NC, Nobre A, Pinto FJ, Costa J, Caldeira D. Preoperative statin therapy for adults undergoing cardiac surgery. Cochrane Database Syst Rev. 2024 Jul 22;7(7):CD008493. doi: 10.1002/14651858.CD008493.pub5.
PMID: 39037762DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jing-song Ou, MD,PhD
The Frist Affiliated Hospital, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
July 26, 2012
First Posted
July 30, 2012
Study Start
January 1, 2013
Primary Completion
December 1, 2024
Study Completion (Estimated)
December 1, 2026
Last Updated
April 21, 2023
Record last verified: 2023-04