Plaque Stability and Metabolomics in Coronary Heart Disease

Coronary Artery Disease Clinical Trial

Official title:

The Relationship Between Plaque Stability Evaluated by IVUS and Metabolomics in Stable Coronary Heart Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270330
• Other study ID #: 2021BJ-02
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

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