Skip to main content
Clinical Trials/NCT05800093
NCT05800093
Active, not recruiting
Not Applicable

Proteomics and Genomics Combined With CT to Predict CVD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country310 target enrollmentJanuary 12, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease Progression
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
310
Locations
1
Primary Endpoint
Coronary Artery Disease Progression
Status
Active, not recruiting
Last Updated
7 months ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 12, 2023
End Date
June 1, 2026
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

E.S.stroes

Principal Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Coronary Artery Disease Progression

Time Frame: Through study completion, between 130-156 weeks

Secondary Outcomes

  • Presence of obstructive stenosis(Through study completion, between 130-156 weeks)
  • 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)
  • Non-calcified plaque volume progression(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)

Study Sites (1)

Loading locations...

Similar Trials