Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: simvastatin.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease, Heart Valve Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Overview
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.
Interventions
- 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.
Primary outcome measures
- troponin [Time frame: within the first 7 days after surgery]
- ejection fraction [Time frame: within two years]
Secondary outcome measures (1)
- long term survival [Time frame: within two years]
Eligibility criteria
Inclusion criteria
- More than 18-year-old,
- Congenital heart disease(not complex),
- Isolated heart valve disease,
Exclusion criteria
- Coronary artery disease
- Allergy for statins
- Poor liver function,Hepatitis
- Gestation women and Breast-feeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
Publications
- 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 39037762
Identifiers
NCT: NCT01653223 · statin2 · 5010-2012001 · 5010-2014002