NCT05270330

Brief 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.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Typical duration 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

July 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

January 22, 2022

Last Update Submit

March 6, 2022

Conditions

Keywords

plaque stabilitymetabonomics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Metabonomics

    07/01/2021-07/31/2024

Interventions

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients who diagnosed with stable coronary heart disease and evaluated for plaque stability by IVUS will be recruited.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2022

First Posted

March 8, 2022

Study Start

July 1, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

March 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations