Proteomics and Genomics Combined With CT to Predict CVD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05800093

Acronym

PREDICT-CVD

Enrollment

310

Registered

2023-04-05

Start date

2023-01-12

Completion date

2026-06-01

Last updated

2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease Progression

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Coronary Artery Disease Progression	Through study completion, between 130-156 weeks

Secondary

Measure	Time frame
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
Presence of obstructive stenosis	Through study completion, between 130-156 weeks
Change in Pericoronary Adipose Tissue CT-Attenuation	Through study completion, between 130-156 weeks
CAD-RADS progression (yes/no)	Through study completion, between 130-156 weeks
Progression in number of high-risk plaque characteristics (yes/no)	Through study completion, between 130-156 weeks
Low-attenuation plaque volume progression	Through study completion, between 130-156 weeks

Countries

Netherlands

Outcome results