Fat Around Heart Arteries as a Measure of Inflammation in Patients With Diabetes

NCT06644651 | Completed

• 1 other identifier: PCAT-DM
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Atherosclerosis, Coronary; Diabetes Mellitus; Diabetes Mellitus Type 2; Inflammation; Inflammation Plaque, Atherosclerotic; Perivascular Disease

Keywords

Atherosclerotic Plaque; Coronary artery disease; Atherosclerosis, coronary; Inflammation; Pericoronary adipose tissue; Coronary inflammation; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• Baseline PCAT attenuation and plaque features at the 12-month CCTA

  Cardiac assessments at the 12-month CCTA scan include: Plaque composition, measured by the volume of different plaque types. Plaque burden is measured as compositional plaque volume adjusted by vessel length (normalized atheroma volume). High-risk plaque features assessed include positive remodeling (PR), low-attenuated plaque (LAP), napkin-ring sign (NRS), and spotty calcifications (SC).

  12 months

• Changes in PCAT attenuation and plaque features at the 12-month CCTA

  Changes in PCAT attenuation from baseline to the 12-month CCTA will be measured. Cardiac assessments at the 12-month CCTA scan include: Plaque composition, measured by the volume of different plaque types. Plaque burden is measured as compositional plaque volume adjusted by vessel length (normalized atheroma volume). High-risk plaque features assessed include positive remodeling (PR), low-attenuated plaque (LAP), napkin-ring sign (NRS), and spotty calcifications (SC).

  12 months

• Baseline PCAT attenuation and MACE

  Baseline PCAT attenuation will be used to predict major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal acute myocardial infarction (AMI), non-fatal stroke, heart failure (HF) de novo, and hospitalization for HF, over a 7-year period following the CCTA scan.

  7 years

• Changes in PCAT attenuation after 12-month and MACE

  Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal acute myocardial infarction (AMI), non-fatal stroke, heart failure (HF) de novo, and hospitalization for HF, over a 7-year period following the CCTA scan.

  7 years

Secondary Outcomes (16)

• PCAT attenuation and de novo heart failure

  7 years

• PCAT attenuation and non-fatal acute myocardial infarction

  7 years

• PCAT attenuation and non-fatal stroke

  7 years

• PCAT attenuation and hospitalization for HF

  7 years

• PCAT attenuation and CV death

  7 years

Study Arms (1)

Participants with type 2 diabetes mellitus

The study population consists of participants with type 2 diabetes mellitus who are cardiac asymptomatic and have no known coronary heart disease. Participants underwent a baseline examination and CCTA scan, followed by a 12-month visit with repeated examinations and a second CCTA scan. A journal audit will be conducted for all participants approximately 7 years after the baseline CCTA scan.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with type 2 diabetes who were cardiac asymptomatic and had no history of CAD. Participants were recruited from the Endocrinology Outpatient Clinic and the Retina Photographhy Clinic at Odense University Hospital, Svendborg, Denmark.

You may qualify if:

• Above 18 years
• Capable of giving written informed consent
• Type 2 diabetes mellitus

You may not qualify if:

• History of CAD
• Symtoms of CAD (angina)
• Any tachyarrhythmias making CCTA impossible
• Estimated glomerular filtration rate (eGFR) under 45 ml/min
• Allergy to iodine contrast
• Critical illness with life expectancy less than 1 year
• Documented heart failure

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Cardiovascular Research Unit

Svendborg, Region Syddanmark, 5700, Denmark

Location

Related Publications (1)

• Overgaard KS, Andersen TR, Heinsen LJ, Pararajasingam G, Mohamed RA, Madsen FS, Biesenbach IIA, Hojlund K, Lambrechtsen J, Auscher S, Egstrup K. Pericoronary adipose tissue attenuation predicts compositional plaque changes: a 12-month longitudinal study in individuals with type 2 diabetes without symptoms or known coronary artery disease. Cardiovasc Diabetol. 2025 Mar 28;24(1):143. doi: 10.1186/s12933-025-02694-9.

  PMID: 40155929 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting blood samples at baseline and at 12 months follow-up within one week from the day of the CCTA. Biochemistry included; HbA1c, low-density lipoprotein (LDL), high-density lipoprotein HDL, triglycerides (TG), creatinine, high-sensitivity C-reactive peptide (hs-CRP), high-sensitivity Troponine T (hs-TNT).

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation; Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Kenneth Egstrup, Professor

  Odense University Hospital - Svendborg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 16, 2024
• Study Start: March 1, 2016
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)