Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

Tracking Information
First Submitted Date ICMJE	July 26, 2012
First Posted Date ICMJE	July 30, 2012
Last Update Posted Date	April 25, 2017
Study Start Date ICMJE	January 2013
Estimated Primary Completion Date	December 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 26, 2012)	troponin [ Time Frame: 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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01653223 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 26, 2012)	ejection fraction [ Time Frame: 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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE; (submitted: July 26, 2012)	long term survival [ Time Frame: within two years ]; Each patient will be followed up and observed survival time.
Original Other Outcome Measures ICMJE	Same as current
Descriptive Information
Brief Title ICMJE	Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
Official Title ICMJE	A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass
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. We recent found simvastatin reduced myocardial injury during noncoronary artery cardiac surgery in single medical center. We 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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
Condition ICMJE	Congenital Heart Disease; Heart Valve Disease
Intervention ICMJE	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 Name: simcor
Study Arms	No Intervention: control untreated; 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. Intervention: Drug: simvastatin; 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. Intervention: Drug: simvastatin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: July 26, 2012)	369
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 2020
Estimated Primary Completion Date	December 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Jing-song Ou, MD, PhD 8620-87755766 ext 8238 oujs2000@yahoo.com Contact: Zhi-ping Wang, MD, PhD 8620-87755766 ext 8238
Listed Location Countries ICMJE	China
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01653223
Other Study ID Numbers ICMJE	statin2; 5010-2012001 ( Other Grant/Funding Number: Sun Yat-sen University ); 5010-2014002 ( Other Grant/Funding Number: Sun Yat-sen University )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Jing-song Ou, Sun Yat-sen University
Study Sponsor ICMJE	Sun Yat-sen University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Jing-song Ou, MD,PhD The Frist Affiliated Hospital, Sun Yat-sen University
PRS Account	Sun Yat-sen University
Verification Date	April 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP