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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cardiovascular Research Unit
Coordinator of this site? Confirm its status
SvendborgDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.