Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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No Intervention: control untreated |
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Experimental: short statin Simvastatin (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. |
Drug: simvastatin
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.
Other Names:
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Experimental: long statin Simvastatin (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. |
Drug: simvastatin
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- troponin [within the first 7 days after surgery]
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.
- ejection fraction [within two years]
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.
Secondary Outcome Measures
- long term survival [within two years]
Each patient will be followed up and observed survival time.
Eligibility Criteria
Criteria
Inclusion Criteria:
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More than 18-year-old,
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Congenital heart disease(not complex),
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Isolated heart valve disease,
Exclusion Criteria:
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Coronary artery disease
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Allergy for statins
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Poor liver function,Hepatitis
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Gestation women and Breast-feeding women
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Jing-song Ou, MD,PhD, The Frist Affiliated Hospital, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- statin2
- 5010-2012001
- 5010-2014002