Proteomics and Genomics Combined With CT to Predict CVD (PREDICT-CVD)

September 30, 2025 updated by: E.S.stroes, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
This study evaluates plaque progression and characteristics in patients with coronary atherosclerosis.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC, location AMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coronary Artery Disease Progression
Time Frame: Through study completion, between 130-156 weeks
Through study completion, between 130-156 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Erik SG Stroes, MD PhD, Amsterdam UMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL81913.018.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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