Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2016 by Sun Yat-sen University
Sponsor:
Sun Yat-sen University
Information provided by (Responsible Party):
Jing-song Ou, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01653223
First received: July 26, 2012
Last updated: April 21, 2016
Last verified: April 2016
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 26, 2012 | ||||||||
| Last Updated Date | April 21, 2016 | ||||||||
| Start Date ICMJE | January 2013 | ||||||||
| Estimated Primary Completion Date | December 2018 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
troponin [ Time Frame: within the first 7 days after surgery ] [ Designated as safety issue: Yes ] The investigator will measure the plasma troponin level in several time points before and after surgery in each patient. |
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| 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 |
ejection fraction [ Time Frame: within two years ] [ Designated as safety issue: No ] 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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE |
long term survival [ Time Frame: within two years ] [ Designated as safety issue: No ] Each patient will be followed up and observed survival time. |
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| 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 Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE |
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| 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 369 | ||||||||
| Estimated Completion Date | December 2020 | ||||||||
| Estimated Primary Completion Date | December 2018 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older (Adult, Senior) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01653223 | ||||||||
| Other Study ID Numbers ICMJE | statin2, 5010-2012001, 5010-2014002 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Plan to Share Data | Not Provided | ||||||||
| IPD Description | Not Provided | ||||||||
| Responsible Party | Jing-song Ou, Sun Yat-sen University | ||||||||
| Study Sponsor ICMJE | Sun Yat-sen University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Sun Yat-sen University | ||||||||
| Verification Date | April 2016 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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