PREDICT-CVD: Proteomics and Genomics Combined With CT to Predict CVD

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT05800093

Collaborator

(none)

300

Enrollment

Location

46.6

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Progression

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Proteomics and Genomics Combined With CT to Predict CVD

Actual Study Start Date :

Jan 12, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Outcome Measures

Primary Outcome Measures

Coronary Artery Disease Progression [Through study completion, between 130-156 weeks]

Secondary Outcome Measures

Presence of obstructive stenosis [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]
Calcified plaque volume progression [Through study completion, between 130-156 weeks]
Non-calcified plaque volume progression [Through study completion, between 130-156 weeks]
Low-attenuation plaque volume progression [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amsterdam UMC, location AMC	Amsterdam		Netherlands

Sponsors and Collaborators

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

Investigators

Principal Investigator: Erik SG Stroes, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

E.S.stroes, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ClinicalTrials.gov Identifier:

NCT05800093

Other Study ID Numbers:

NL81913.018.22

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Disease Progression

Study Results

No Results Posted as of Apr 5, 2023