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Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Jing-song Ou, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01653223
First received: July 26, 2012
Last updated: April 24, 2017
Last verified: April 2017

July 26, 2012
April 24, 2017
January 2013
December 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01653223 on ClinicalTrials.gov Archive Site
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
Same as current
long term survival [ Time Frame: within two years ]
Each patient will be followed up and observed survival time.
Same as current
 
Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Prevention
  • Congenital Heart Disease
  • Heart Valve Disease
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
369
December 2020
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Jing-song Ou, MD, PhD 8620-87755766 ext 8238 oujs2000@yahoo.com
Contact: Zhi-ping Wang, MD, PhD 8620-87755766 ext 8238
China
 
 
NCT01653223
statin2
5010-2012001 ( Other Grant/Funding Number: Sun Yat-sen University )
5010-2014002 ( Other Grant/Funding Number: Sun Yat-sen University )
Yes
Not Provided
Not Provided
Not Provided
Jing-song Ou, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Jing-song Ou, MD,PhD The Frist Affiliated Hospital, Sun Yat-sen University
Sun Yat-sen University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP