Carotid Plaque Length to Predict Cardiovascular Events

June 3, 2022 updated by: Pan Li, Changhai Hospital
This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). The study enrolled 5000 patients for suspected CAD who referred to coronary angiography from January 2017 through December 2018.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Patients with coronary artery disease who were confirmed by coronary angiography were eligible for the study. Carotid ultrasonography was performed before coronary angiography, and carotid intima-media thickness (IMT), maximum thickness and length of all plaques were measured.

Study Type

Observational

Enrollment (Actual)

5000

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
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • No. 904 Hospital of the PLA Joint Logistics Support Force
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Changhai Hospital
      • Shanghai, Shanghai, China, 200000
        • Gongli Hospital
      • Shanghai, Shanghai, China, 200000
        • Putuo Hospital
      • Shanghai, Shanghai, China, 200000
        • Yueyang Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients hospitalized for first coronary angiography and underwent carotid ultrasonography simultaneously

Description

Inclusion Criteria:

  • Patients≥18 years old, those who underwent carotid ultrasonography and first coronary angiography simultaneously.

Exclusion Criteria:

  • Patients with known coronary artery disease, previous coronary or carotid revascularization, missing carotid ultrasound or coronary angiography results.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Carotid plaque length
Patients underwent carotid ultrasonography and first coronary angiography simultaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major cardiovascular event
Time Frame: 3 years
A composite of cardiovascular death, myocardial infarction, and ischemic stroke
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major vascular event
Time Frame: 3 years
A composite of cardiovascular death, myocardial infarction, ischemic stroke, and coronary artery revascularization
3 years
all-cause death
Time Frame: 3 years
3 years
cardiovascular death
Time Frame: 3 years
3 years
myocardial infarction
Time Frame: 3 years
3 years
ischemic stroke
Time Frame: 3 years
3 years
coronary artery revascularization
Time Frame: 3 years
coronary artery bypass grafting or percutaneous coronary intervention
3 years

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Collaborators

Putuo Hospital, Shanghai University of Traditional Chinese Medicine
No. 904 Hospital of the PLA Joint Logistics Support Force
Gongli Hospital
Yueyang Hospital, Shanghai University of Traditional Chinese medicine

Investigators

  • Principal Investigator: Pan Li, PhD, Changhai Hospital
  • Study Director: Jian Na, MD, Putuo Hospital
  • Study Director: Liang Chen, MD, No. 904 Hospital of the PLA Joint Logistics Support Force
  • Study Director: Wei Zhang, MD, Gongli Hospital
  • Study Director: Yawei Yang, MD, Yueyang 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)

January 1, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

June 3, 2022

First Submitted That Met QC Criteria

June 3, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPLi-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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