Lp(a) With CCTA Assessed Parameters and Clinical Outcomes

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Coronary CTA

• Registration Number: NCT05323227
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

Lipoprotein(a) \[Lp(a)\] is a risk factor for cardiovascular events, although the underlying mechanism remains unclear. This study evaluated the relationship between Lp(a) and high-risk attributes (HRA) by coronary computed tomography angiography (CCTA) as well as their prognostic value.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-20
• Status Verified: 2022-04
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Last Update Submitted: 2022-04-04
• Study First Posted: 2022-04-12
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

• Patients with Lp(a) meaured within 1 week of CCTA examination.

Exclusion Criteria

• unstable angina pectoris
• acute myocardial infarction
• New York Heart Association class III-IV heart failure
• with a history of bypass surgery
• active infection
• respiratory failure
• chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 ml/min/1.73 m2)
• liver dysfunction (liver enzyme >3 upper reference limit [URL] or bilirubin >2 URL)
• malignancy
• systemic connective tissue disease
• poor CCTA imaging quality not suitable for analysis
• other situations not suitable for the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Coronary CTA	Patients with Lp(a) \<60mg/dL
Group 2	Coronary CTA	Patients with Lp(a) ≥60 mg/dL

Primary Outcome Measures

Name	Time	Method
Association of Lp(a) level with CCTA measured Parameters	at the index procedure	Association of Lp(a) level with CCTA measured high-risk plaque characteristics
Major adverse cardiac events	at 24 months from index procedure	a composite of cardiac death, any myocardial infarction, and stroke

Secondary Outcome Measures

Name	Time	Method
Cardiac death	at 24 months from index procedure	Cardiac death
Myocardial infarction	at 24 months from index procedure	Myocardial infarction
Stroke	at 24 months from index procedure	stroke

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China