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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05270330
Other study ID # 2021BJ-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date July 31, 2024

Study information

Verified date March 2022
Source Shaanxi Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

At present, the investigators don't know the relationship between plaque stability and the metabonomics changes. In the present study, investigators will evaluate the plaque stability by intravascular unltrasound in stable coronary heart patients, and metabonomics was also assessed by high throughput sequencing. Statistic analysis were carried out to analyze the correlation between plaque stability and metabonomics changes among these study patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patients who diagnosed with stable coronary heart disease and evaluated for plaque stability by IVUS will be recruited. Exclusion Criteria: - renal insufficiency with serum creatinine > 20 mg/L; - regnant/lactating women, or the women receive hormone replacement therapy in premenopausal or postmenopausal; - patients have a history of abusing alcohol or other drugs in the past two years, active hepatitis, cirrhosis; - endocrine abnormalities without therapy (diabetic ketoacidosis, thyroid disease, etc.); - The body's inflammatory disease, rheumatoid arthritis, osteoarthritis, ulcerative bowel disease, systemic lupus erythematosus (sle), etc.), myositis/myopathy, cancer; - Dilated cardiomyopathy, valvular heart disease, persistent atrial fibrillation; - patients recently injured;(8)Other researchers don't agree to join this study.

Study Design


Intervention

Other:
This is an observational study, we don't have any interventions.
No intervention

Locations

Country Name City State
China Shaanxi Provincial People's Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Shaanxi Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plaque stability The investigators will use the intravascular ultrasound to assess the coronary plaque stability of the patients with coronary heart disease. 07/01/2021-07/31/2024
Secondary Metabonomics Serum or plasma will be collected by the investigators and high-throughput sequencing will be used to assess the metabonomics of patients with coronary heart disease. 07/01/2021-07/31/2024
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