- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012994
Retrospective Study of the Protective Effect of Gastrodin on Myocardium in Patients Undergoing Cardiac Surgery
August 25, 2023 updated by: Wuhan Union Hospital, China
Retrospective collection of Wuhan Union hospital from December 1,2018 to June 30,2021 to meet the entry and discharge standards.
The patient 's medical record data were divided into study group and control group according to the use of gastrodin during operation.
The perioperative data and prognostic outcomes in the patient 's medical records were collected and analyzed.
The degree of myocardial injury and postoperative clinical outcomes were compared between the two groups.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hubei
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Wuhan, Hubei, China, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
This study included patients who were preoperatively diagnosed as requiring elective thoracic cardiac surgery under general anesthesia.
Description
Inclusion Criteria:
- Patients aged≥18 years, regardless of gender;
- Patients undergoing elective cardiac surgery under general anesthesia;
- ASA grade 1 ~ 3.
Exclusion Criteria:
- Suffering from more serious genetic diseases (such as immunodeficiency, thalassemia, etc.);
- Moderate to severe malnutrition, moderate to severe anemia;
- Persistent infection;
- Severe preoperative underlying diseases (such as severe liver and kidney dysfunction)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Control
|
GAS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degree of myocardial injury
Time Frame: The myocardial tissue was collected during the operation. About 2 hours on average
|
The myocardial tissue trimmed by the surgeon according to the surgical requirements was collected during the operation for electron microscopy observation and detection of related molecular content.
|
The myocardial tissue was collected during the operation. About 2 hours on average
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
August 20, 2023
First Submitted That Met QC Criteria
August 25, 2023
First Posted (Actual)
August 28, 2023
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 25, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- mzk202303
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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