Proteomics and Genomics Combined With CT to Predict CVD

Coronary Artery Disease Progression Clinical Trial

— PREDICT-CVD  

Official title:

Proteomics and Genomics Combined With CT to Predict CVD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800093
• Other study ID #: NL81913.018.22
• Status: Recruiting
• Start date: January 12, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: March 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Erik SG Stroes, MD PhD
• Phone: +31205669111
• Email: e.s.stroes[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2026
• Est. primary completion date: April 1, 2026
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Progression
• Disease Progression

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Artery Disease Progression		Through study completion, between 130-156 weeks
Secondary	Presence of obstructive stenosis		Through study completion, between 130-156 weeks
Secondary	Progression in number of significant (>50%) and severe (>70%) stenoses		Through study completion, between 130-156 weeks
Secondary	Total plaque volume progression		Through study completion, between 130-156 weeks
Secondary	Calcified plaque volume progression		Through study completion, between 130-156 weeks
Secondary	Non-calcified plaque volume progression		Through study completion, between 130-156 weeks
Secondary	Low-attenuation plaque volume progression		Through study completion, between 130-156 weeks
Secondary	Change in Pericoronary Adipose Tissue CT-Attenuation		Through study completion, between 130-156 weeks
Secondary	CAD-RADS progression (yes/no)		Through study completion, between 130-156 weeks
Secondary	Progression in number of high-risk plaque characteristics (yes/no)		Through study completion, between 130-156 weeks