NCT06012968

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 20, 2023

Last Update Submit

August 25, 2023

Conditions

Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • Degree of myocardial cell injury

    Postoperative myocardial injury marker serum concentration, postoperative cardiac function ultrasound index

    During postoperative hospitalization stay, an average of about two weeks

Study Arms (2)

GAS

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients with hypertrophic cardiomyopathy aged≥18 years, regardless of gender;
  • Patients undergoing elective hypertrophic cardiomyopathy outflow tract surgery;
  • Signed informed consent, good compliance.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Central Study Contacts

Qingping Wu, doctor

CONTACT

13971605283wqp1968@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2023

First Posted

August 28, 2023

Study Start

August 1, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations

CN(1)