Evaluating Atherosclerotic Disease Progression in Patient... | NCT07237685

Studies
Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus

NCT07237685

Sponsor

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

Status

Recruiting

Last Update Posted

Nov 20, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Type 2 Diabetes
Coronary Artery Disease (CAD)
Atherosclerosis Cardiovascular Disease

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

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2025Actual

Primary Completion Date

Oct 1, 2026Estimated

Completion Date

Oct 1, 2036Estimated

First Submitted Date

Sep 24, 2025

First Submission Date that Met QC Criteria

Nov 18, 2025

First Posted Date

Nov 20, 2025Actual

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

Nov 18, 2025

Last Update Posted Date

Nov 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

M.M. Winter, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Horizon Innovative Health Initiative	UNKNOWN
Novo Nordisk A/S	INDUSTRY
INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA (IBSAL)	UNKNOWN
Cardiology Centers of the Netherlands

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

People with type 2 diabetes have a much higher risk of heart disease. One common problem is when the blood vessels that supply the heart become narrowed or blocked by fatty deposits, called plaque. This makes it harder for blood to reach the heart and can lead to serious problems such as chest pain, heart attacks, or even death.

This study will follow people with type 2 diabetes who have already had a special heart scan called a coronary CT angiography. This scan takes detailed pictures of the heart's blood vessels.

The goal is to understand how heart disease changes over time in people with type 2 diabetes, by looking at repeat scans and other health information. By learning more about how plaque builds up or gets worse, researchers hope to find better ways to identify which patients are most at risk for future heart problems.

Detailed Description

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

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression of total coronary plaque volume (mm3)	The primary study parameter will be the progression of total coronary plaque volume (mm3). This will be calculated by subtracting the coronary plaque volume measured in the first CCTA from the total plaque volume measured in the follow-up CCTA. The plaque volume will be determined by dividing the total plaque volume by the total vesssel volume	Between baseline (retrospective) and follow up CCTA (interval 2-5 years).

Secondary Outcomes

Measure	Description	Time Frame
Changes in Coronary Artery Disease Reporting and Data Scale(CAD-RADS) scores	Change in the percentage of luminal narrowing per lesion as defined by the Coronary Artery Disease Reporting and Data Scale(CAD-RADS) score (minimum 0, maximum 5).	Between baseline (retrospective) and follow up CCTA (interval 2-5 years)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18 years
Previous completion of CCTA scan for CAD assessment
Diagnosed with Type 2 Diabetes and currently receiving glucose lowering treatment
Sufficient image quality of the CCTA scan (at least 2/3 vessels of sufficient quality for assessment).

Exclusion Criteria:

Inability to provide written informed consent
Presence of an unstable condition
Ingeligibility for CCTA acquisition due to severe renal dysfunction (eGFR ≤ 30 mL/min/1.73m²) or known hypersensitivity or contraindication to CT contrast agents
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
Baseline (routine care) CCTA performed < 2 years or > 5 years before inclusion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

In this study, patients with T2D who previously undergone CCTA for CAD assessment will be recruited. Patients will be included at three clinical sites: Amsterdam UMC, Cardiology centre Netherlands (CCN), University hospital of Salamanca - Fundacion Instituto de Estudios de ciencias de la salud de castilla y leon (IBSAL).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Willem R van de Vijver, MD	Contact	+31205662402		w.r.vandevijver@amsterdamumc.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amsterdam University Medical Centers	Not yet recruiting	Amsterdam			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided