Proteomics and Genomics Combined With CT to Predict CVD

NCT ID: NCT05800093

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-12

Study Completion Date

2026-06-01

Brief Summary

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

Detailed Description

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Conditions

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Coronary Artery Disease Progression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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E.S.stroes

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik SG Stroes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

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Amsterdam UMC, location AMC

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL81913.018.22

Identifier Type: -

Identifier Source: org_study_id

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