Proteomics and Genomics Combined With CT to Predict CVD | NCT05800093

Studies
Proteomics and Genomics Combined With CT to Predict CVD

NCT05800093

Sponsor

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

Status

Active, not recruiting

Last Update Posted

Oct 2, 2025Actual

Enrollment

310Actual

Phase

Not provided

Conditions

Coronary Artery Disease Progression

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2023Actual

Primary Completion Date

Jan 30, 2026Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Mar 13, 2023

First Submission Date that Met QC Criteria

Mar 23, 2023

First Posted Date

Apr 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2025

Last Update Posted Date

Oct 2, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

310Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Name	Affiliation	Role
Erik SG Stroes, MD PhD	Amsterdam UMC	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided