Clinical trial NCT05409209: Carotid Plaque Length to Predict Cardiovascular Events
Official title: Carotid Plaque Length to Predict Cardiovascular Events
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: Carotid Artery Ultrasound
Carotid Plaque
Coronary Artery Disease
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Putuo Hospital, Shanghai University of Traditional Chinese Medicine
name: 904th Hospital of the Joint Logistics Support Force of the PLA
name: Gongli Hospital
name: Yueyang Hospital, Shanghai University of Traditional Chinese medicine
First posted: 2022-06-08
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized for first coronary angiography and underwent carotid ultrasonography simultaneously

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 3000 patients for suspected CAD who referred to coronary angiography from January 2017 through December 2018.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: major cardiovascular event
timeFrame: 3 years
Secondary outcomes:
measure: major vascular event
timeFrame: 3 years
measure: all-cause death
timeFrame: 3 years
measure: cardiovascular death
timeFrame: 3 years
measure: myocardial infarction
timeFrame: 3 years
measure: ischemic stroke
timeFrame: 3 years
measure: coronary artery revascularization
timeFrame: 3 years
Other outcomes:
Locations:
city: Wuxi
country: China
facility: No. 904 Hospital of the PLA Joint Logistics Support Force
state: Jiangsu
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Gongli Hospital
state: Shanghai
city: Shanghai
country: China
facility: Putuo Hospital
state: Shanghai
city: Shanghai
country: China
facility: Yueyang Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Pan Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Putuo Hospital
name: Jian Na, MD
role: STUDY_DIRECTOR
affiliation: 904th Hospital of the Joint Logistics Support Force of the PLA
name: Liang Chen, MD
role: STUDY_DIRECTOR
affiliation: Gongli Hospital
name: Wei Zhang, MD
role: STUDY_DIRECTOR
affiliation: Yueyang Hospital
name: Yawei Yang, MD
role: STUDY_DIRECTOR
References: