NCT06644651Completed
Fat Around Heart Arteries as a Measure of Inflammation in Patients With Diabetes
Prospective Associations of Pericoronary Adipose Tissue Computed Tomography Attenuation With Coronary Plaque Features and Major Adverse Cardiovascular Events in a Population With Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 31 Jul 2025
Brief summary (registry, in English)
In this prospective study, the objective is to investigate inflammation in the arteries of the heart. A heart CT scan (CCTA) will be used to measure inflammation by assessing the fat tissue surrounding the arteries of the heart. Participants with type 2 diabetes who have no heart symptoms have been examined, using a CCTA at the start of the study and again after 12 months. This study aims to answer the following questions: * Can inflammation in the surrounding fat tissue at the baseline CCTA predict the amount and type of plaque, and the presence of harmful plaque characteristics present after 12 months? (paper 1) * Do changes in inflammation in the surrounding fat tissue from baseline to the 12 months CCTA correlate with the amount and type of plaque and the presence of harmful plaque characteristics at the 12 months CCTA? (paper 1) * Is inflammation in the surrounding fat tissue a predictor for the development of cardiovascular events after a follow-up period of 7 years? (paper 2) * Do changes in inflammation in the surrounding fat tissue after 12 months predict the later development of cardiovascular events after a follow-up period of 7 years? (paper 2)
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 314 (actual)
- First submitted
- 15 Oct 2024
- Start date
- 1 Mar 2016
- Primary completion date
- Feb 2025
- Lead sponsor
- Odense University Hospital
- Diseases
- Coronary artery disease, Type 2 diabetes
- NCT number
- NCT06644651
What you commit to
- Study type: Observational
- Participants enrolled: 314
- From 1 Mar 2016 to the primary completion date, Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of CAD
- Symtoms of CAD (angina)
- Allergy to iodine contrast
- Critical illness with life expectancy less than 1 year
- Documented heart failure
Lab values
- Estimated glomerular filtration rate (eGFR) under 45 ml/min
Other
- Any tachyarrhythmias making CCTA impossible
Who the study is looking for
- Above 18 years
- Capable of giving written informed consent
- Type 2 diabetes mellitus
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiovascular Research Unit Coordinator of this site? Confirm its status | Svendborg | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.