Proteomics and Genomics Combined With CT to Predict CVD

Active, not recruiting

• Conditions: Coronary Artery Disease Progression

• Registration Number: NCT05800093
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

This study evaluates plaque progression and characteristics in patients with coronary atherosclerosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-12
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Adult patients between 50 and 75 years old
• Subjects at intermediate to high risk for ASCVD
• Asymptomatic patients without cardiac chest pain
• Evidence of atherosclerosis on baseline CCTA

Exclusion Criteria

• Renal insufficiency, defined as eGFR < 30 ml/min
• History of cardiovascular events (myocardial infarction, peripheral artery disease and ischemic stroke)
• Use of lipid lowering therapy other than statin, ezetimibe or bempedoic acid monotherapy
• Change in lipid lowering therapy in the last 6 months
• Use of more than two antihypertensive agents
• No coronary atherosclerosis at baseline imaging
• Active malignancy requiring treatment
• Atrial fibrillation
• Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
• Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary Artery Disease Progression	Through study completion, between 130-156 weeks

Secondary Outcome Measures

Name	Time	Method
Presence of obstructive stenosis	Through study completion, between 130-156 weeks
Calcified plaque volume progression	Through study completion, between 130-156 weeks
Non-calcified plaque volume progression	Through study completion, between 130-156 weeks
Change in Pericoronary Adipose Tissue CT-Attenuation	Through study completion, between 130-156 weeks
Progression in number of high-risk plaque characteristics (yes/no)	Through study completion, between 130-156 weeks
Progression in number of significant (>50%) and severe (>70%) stenoses	Through study completion, between 130-156 weeks
Total plaque volume progression	Through study completion, between 130-156 weeks
Low-attenuation plaque volume progression	Through study completion, between 130-156 weeks
CAD-RADS progression (yes/no)	Through study completion, between 130-156 weeks

Trial Locations

Locations (1)

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Netherlands