Plaque Stability and Metabolomics in Coronary Heart Disease

March 6, 2022 updated by: Liu Zhongwei, Shaanxi Provincial People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with stable coronary heart disease and assessed for plaque stability by IVUS will be recruited in our study.

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque stability
Time Frame: 07/01/2021-07/31/2024
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabonomics
Time Frame: 07/01/2021-07/31/2024
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaanxi Provincial People's Hospital

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 (Actual)

July 1, 2021

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

January 22, 2022

First Submitted That Met QC Criteria

March 6, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 6, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021BJ-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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