Association Between Carotid Plaque Length and Cardiovascular Outcomes

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 consecutive patients without known CAD who underwent first coronary angiography for stable chest pain and carotid ultrasound was performed during hospitalization from January 2017 through December 2018.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Carotid Plaque

Detailed Description

Patients who had obstructive CAD (defined as ≥50% luminal stenosis) confirmed by coronary angiography and who underwent carotid scanning were included in the final analysis.Carotid ultrasonography was performed simultaneously, and carotid intima-media thickness (IMT), maximum thickness and length of all plaques were measured.The incidence of major adverse cardiovascular events was recorded during follow-up.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive patients without known CAD who underwent first coronary angiography for stable chest pain and carotid ultrasound was performed during hospitalization.

Description

Inclusion Criteria:

• Patients who underwent coronary angiography for stable chest pain and carotid ultrasound simultaneously;
• Patients with obstructive CAD (≥50% coronary stenosis);

Exclusion Criteria:

• <18 years of age;
• previous carotid surgery or significant carotid artery disease;
• prior stroke or transient ischemic attack;
• previously documented CAD (including history of myocardial infarction, acute coronary syndrome, or coronary revascularization);

Study Plan

How is the study designed?

Number of groups / cohorts

1

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 adverse cardiovascular events	cardiovascular death, myocardial infarction, ischemic stroke and coronary revascularization	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
all-cause death	3 years
cardiovascular death	3 years
myocardial infarction	3 years
ischemic stroke	3 years
coronary artery revascularization	3 years
heart failure	3 years

Collaborators and Investigators

• 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: 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 Director: Jian Jian Na, MD, Putuo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 31, 2022
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Carotid Artery Ultrasound; Carotid Plaque
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CPL

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