Cardiac Surgical ProceduresNCT06012968
Study on the Protective Effect of Gastrodin on Myocardial Injury in Patients Undergoing Cardiac Surgery
An observational study of Cardiac Surgical Procedures, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with hypertrophic cardiomyopathy aged≥18 years, regardless of gender;
- Patients undergoing elective hypertrophic cardiomyopathy outflow tract surgery;
- Signed informed consent, good compliance.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Qingping Wu, wqp1968@163.com
About this study
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.
- Conditions
- Cardiac Surgical Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GAS | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of myocardial cell injury
Postoperative myocardial injury marker serum concentration, postoperative cardiac function ultrasound index
Measured: During postoperative hospitalization stay, an average of about two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012968
- Sponsor's protocol ID
- mzk202301
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Protective Effect of Gastrodin on Myocardial Injury in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06012968
- Acronym / sponsor ID
- mzk202301
- Conditions
- Cardiac Surgical Procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAS | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with hypertrophic cardiomyopathy aged≥18 years, regardless of gender;
- Patients undergoing elective hypertrophic cardiomyopathy outflow tract surgery;
- Signed informed consent, good compliance.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Procedures, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingping Wu, doctor (13971605283, wqp1968@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of myocardial cell injury (time frame: During postoperative hospitalization stay, an average of about two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.