Proteomics and Genomics Combined With CT to Predict CVD

NCT05800093 | Active Not Recruiting

• 1 other identifier: NL81913.018.22
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease Progression

Outcome Measures

Primary Outcomes (1)

• Coronary Artery Disease Progression

  Through study completion, between 130-156 weeks

Secondary Outcomes (9)

• Presence of obstructive stenosis

  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

• Calcified plaque volume progression

  Through study completion, between 130-156 weeks

• Non-calcified plaque volume progression

  Through study completion, between 130-156 weeks

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients between 50 and 75 years old with nonobstructive coronary artery disease

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Location

Study Officials

• Erik SG Stroes, MD PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 5, 2023
• Study Start: January 12, 2023
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)