Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT01653223
Collaborator
(none)
369
1
3
155
2.4

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
369 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • simcor
  • 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.

    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 Names:
  • simcor
  • Outcome Measures

    Primary Outcome Measures

    1. troponin [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. This is mainly for the comparason between control and short statin, which has been proved in our previous clinical trial: statin1.

    2. ejection fraction [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. This is mainly for the comparason between short statin and long statin, which is the major goal in this clinical trial: statin 2.

    Secondary Outcome Measures

    1. long term survival [within two years]

      Each patient will be followed up and observed survival time.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong China 510080

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Jing-song Ou, MD,PhD, The Frist Affiliated Hospital, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jing-song Ou, Director, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT01653223
    Other Study ID Numbers:
    • statin2
    • 5010-2012001
    • 5010-2014002
    First Posted:
    Jul 30, 2012
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022

    Study Results

    No Results Posted as of Mar 18, 2022