Clinical trial NCT05843487: Association Between Carotid Plaque Length and Cardiovascular Outcomes
Official title: Association Between Carotid Plaque Length and Cardiovascular Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Carotid Plaque
Keywords: Carotid Artery Ultrasound
Carotid Plaque
Coronary Artery Disease
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Yueyang Hospital, Shanghai University of Traditional Chinese medicine
name: Putuo Hospital, Shanghai University of Traditional Chinese Medicine
name: 904th Hospital of the Joint Logistics Support Force of the PLA
name: Gongli Hospital
First posted: 2023-05-06
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: Consecutive patients without known CAD who underwent first coronary angiography for stable chest pain and carotid ultrasound was performed during hospitalization.

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.

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.

Eligibility criteria: 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);

Primary outcomes:
measure: major adverse cardiovascular events
timeFrame: 3 years
Secondary outcomes:
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
measure: heart failure
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 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: