- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012968
Study on the Protective Effect of Gastrodin on Myocardial Injury in Patients Undergoing Cardiac Surgery
August 25, 2023 updated by: Wuhan Union Hospital, China
This study intends to include hypertrophic cardiomyopathy patients over 18 years old who underwent cardiac surgery in our hospital.
Patients were divided into medication group and control group according to the use of gastrodin during operation.
The patients ' myocardial tissue samples were collected, the postoperative prognosis data were observed and recorded, and the data were analyzed.
The degree of myocardial tissue cell damage and postoperative clinical outcomes were compared between the two groups.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qingping Wu, doctor
- Phone Number: 13971605283
- Email: wqp1968@126.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430022
- Recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Qingping Wu
- Email: wqp1968@163.com
-
-
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
The patients included in this study were preoperatively diagnosed as hypertrophic cardiomyopathy.
Diagnosis of hypertrophic cardiomyopathy: according to the medical history and physical examination, echocardiography showed diastolic ventricular septal thickness of 15 mm.
Description
Inclusion Criteria:
- Patients with hypertrophic cardiomyopathy aged≥18 years, regardless of gender;
- Patients undergoing elective hypertrophic cardiomyopathy outflow tract surgery;
- Signed informed consent, good compliance.
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 |
|---|---|---|
|
Degree of myocardial cell injury
Time Frame: During postoperative hospitalization stay, an average of about two weeks
|
Postoperative myocardial injury marker serum concentration, postoperative cardiac function ultrasound index
|
During postoperative hospitalization stay, an average of about two weeks
|
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 (Estimated)
August 1, 2023
Primary Completion (Estimated)
October 1, 2023
Study Completion (Estimated)
October 1, 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
- mzk202301
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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