We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

This study is currently recruiting participants.
Verified April 2017 by Jing-song Ou, Sun Yat-sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01653223
First Posted: July 30, 2012
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jing-song Ou, Sun Yat-sen University
  Purpose
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.

Condition Intervention
Congenital Heart Disease Heart Valve Disease Drug: simvastatin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jing-song Ou, Sun Yat-sen University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • long term survival [ Time Frame: within two years ]
    Each patient will be followed up and observed survival time.


Estimated Enrollment: 369
Study Start Date: January 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: simcor

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653223


Contacts
Contact: Jing-song Ou, MD, PhD 8620-87755766 ext 8238 oujs2000@yahoo.com
Contact: Zhi-ping Wang, MD, PhD 8620-87755766 ext 8238

Locations
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Cong-zhi Rao, MD    87333122    raoczh@mail.sysu.edu.cn   
Principal Investigator: Jing-song Ou, MD,PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Jing-song Ou, MD,PhD The Frist Affiliated Hospital, Sun Yat-sen University
  More Information

Responsible Party: Jing-song Ou, associate chief, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01653223     History of Changes
Other Study ID Numbers: statin2
5010-2012001 ( Other Grant/Funding Number: Sun Yat-sen University )
5010-2014002 ( Other Grant/Funding Number: Sun Yat-sen University )
First Submitted: July 26, 2012
First Posted: July 30, 2012
Last Update Posted: April 25, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Simvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors