Association Between Carotid Plaque Length and Cardiovascular Outcomes

Sponsor

Changhai Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05843487

Collaborator

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

3,000

Enrollment

Locations

168

Anticipated Duration (Months)

600

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Association Between Carotid Plaque Length and Cardiovascular Outcomes

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Carotid plaque length Patients underwent carotid ultrasonography and first coronary angiography simultaneously

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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);

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	No. 904 Hospital of the PLA Joint Logistics Support Force	Wuxi	Jiangsu	China	214000
2	Changhai Hospital	Shanghai	Shanghai	China	200000
3	Gongli Hospital	Shanghai	Shanghai	China	200000
4	Putuo Hospital	Shanghai	Shanghai	China	200000
5	Yueyang Hospital	Shanghai	Shanghai	China	200000

Sponsors and Collaborators

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

Investigators

Principal Investigator: Pan Li, PhD, Changhai Hospital
Study Director: Jian 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