NCT07237685

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
127mo left

Started Jun 2025

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jun 2025Oct 2036

Study Start

First participant enrolled

June 6, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2036

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

September 24, 2025

Last Update Submit

November 18, 2025

Conditions

Type 2 DiabetesCoronary Artery Disease (CAD)Atherosclerosis Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • 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 (9)

  • Changes in Coronary Artery Disease Reporting and Data Scale(CAD-RADS) scores

    Between baseline (retrospective) and follow up CCTA (interval 2-5 years)

  • Progression of calcified plaque volume (mm3)

    Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  • Progression of non-calcified plaque volume (mm3)

    Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  • Progression of low attenuation plaque volume (mm3)

    Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  • Changes in coronary artery calcium score

    Baseline (retrospective) and follow up CCTA (interval 2-5 years)

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amsterdam University Medical Centers

Amsterdam, Netherlands

NOT YET RECRUITING

Cardiology Centers of the Netherlands

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Coronary Artery Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Willem R van de Vijver, MD

CONTACT

+31205662402w.r.vandevijver@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2025

First Posted

November 20, 2025

Study Start

June 6, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2036

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

NL(2)