Association Between Carotid Plaque Length and Cardiovascular Outcomes

Coronary Artery Disease Clinical Trial

Official title:

Association Between Carotid Plaque Length and Cardiovascular Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05843487
• Other study ID #: CPL
• Status: Active, not recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2030

Study information

• Verified date: June 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2030
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Carotid Plaque
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai
China	Gongli Hospital	Shanghai	Shanghai
China	Putuo Hospital	Shanghai	Shanghai
China	Yueyang Hospital	Shanghai	Shanghai
China	No. 904 Hospital of the PLA Joint Logistics Support Force	Wuxi	Jiangsu

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardiovascular events	cardiovascular death, myocardial infarction, ischemic stroke and coronary revascularization	3 years
Secondary	all-cause death		3 years
Secondary	cardiovascular death		3 years
Secondary	myocardial infarction		3 years
Secondary	ischemic stroke		3 years
Secondary	coronary artery revascularization		3 years
Secondary	heart failure		3 years