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OpenTrials
Active, Not Recruiting

NCT Number: NCT05800093

Proteomics and Genomics Combined With CT to Predict CVD

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Progression

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Coronary Artery Disease Progression

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

Secondary outcomes

  1. Presence of obstructive stenosis

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

  2. Progression in number of significant (>50%) and severe (>70%) stenoses

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

  3. Total plaque volume progression

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

  4. Calcified plaque volume progression

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

  5. Non-calcified plaque volume progression

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

  6. Low-attenuation plaque volume progression

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

  7. Change in Pericoronary Adipose Tissue CT-Attenuation

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

  8. CAD-RADS progression (yes/no)

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

  9. Progression in number of high-risk plaque characteristics (yes/no)

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: PREDICT-CVD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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