Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
More than 18-year-old,
Congenital heart disease(not complex),
Isolated heart valve disease,
Disqualifiers
Coronary artery disease
Allergy for statins
Poor liver function,Hepatitis
Gestation women and Breast-feeding women
Trial design
Design model
Parallel
Treatments tested in this trial
simvastatin
DrugIn 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.
Treatment groups
369 Participants
are divided into 3 treatment groupsGroup A: controlNo intervention 0 interventions
Group B: short statinExperimental treatment 1 intervention
Group C: long statinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
within the first 7 days after surgery2
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.
Time frame
within two yearsSecondary outcomes
1
long term survival
Each patient will be followed up and observed survival time.
Time frame
within two yearsSponsors and contacts
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Source ClinicalTrials.gov