Clinical trial NCT06644651: Fat Around Heart Arteries As a Measure of Inflammation in Patients with Diabetes
Official title: Prospective Associations of Pericoronary Adipose Tissue Computed Tomography Attenuation with Coronary Plaque Features and Major Adverse Cardiovascular Events in a Population with Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

Detailed description: Background and significance:

Inflammation in the coronary arteries plays a significant role in the development of heart disease, particularly in individuals with type 2 diabetes (T2D), who are at an increased risk. However, this inflammation has been difficult to detect because the currently used biomarkers have limited accuracy in identifying inflammation in the coronary arteries.

Exiting advancements have been made in the field of coronary CT angiography (CCTA). CCTA enables the measurement of the pericoronary adipose tissue (PCAT) attenuation, which refers to the fat tissue surrounding the coronary arteries. PCAT and the coronary arteries have a bidirectional communication, and when PCAT is exposed to high inflammation it causes the fat-structure to change. These structural changes in PCAT can be detected with a CCTA scan. Additionally, a CCTA scan can assess plaque characteristics, such as the amount of plaque (burden), the type of plaque (composition), and the presence of high-risk plaque features, all of which, are linked to major adverse cardiovascular events (MACE). Furthermore, recent studies have shown that PCAT attenuation can predict cardiac events and mortality.

The PCAT-DM study is a post-hoc analysis from the CARPE-DM study (NCT03016910). The goal of this prospective study is to investigate whether PCAT attenuation and/or PCAT changes are associated with high-risk plaque features, plaque composition and burden. Additionally, the study aims to investigate whether PCAT attenuation and/or PCAT changes can predict development of MACE over a follow-up period of 7 years.

Setting and study population:

A single-center prospective observational study at Odense University Hospital, Svendborg, Denmark. The study enrollment began in March 2016 and ended in September 2017. The study population consists of cardiovascularly asymptomatic participants with type 2 diabetes mellitus.

Examinations:

A total of 314 patients were examined with a CCTA scan at baseline and again after 12 months. The following examinations were conducted at baseline:

* CCTA scan
* CAC-score
* Blood pressure and pulse frequency
* Height, weight, waist to hip-ratio
* Blood samples and urin samples
* Medical history After 12 months, all of the above examinations were repeated.

Journal audits will be performed in the period from September 2024 to January 2025 to examine the number of clinical events according to the primary and secondary outcomes.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Baseline PCAT attenuation and plaque features at the 12-month CCTA
timeFrame: 12 months
measure: Changes in PCAT attenuation and plaque features at the 12-month CCTA
timeFrame: 12 months
measure: Baseline PCAT attenuation and MACE
timeFrame: 7 years
measure: Changes in PCAT attenuation after 12-month and MACE
timeFrame: 7 years
Secondary outcomes:
measure: PCAT attenuation and de novo heart failure
timeFrame: 7 years
measure: PCAT attenuation and non-fatal acute myocardial infarction
timeFrame: 7 years
measure: PCAT attenuation and non-fatal stroke
timeFrame: 7 years
measure: PCAT attenuation and hospitalization for HF
timeFrame: 7 years
measure: PCAT attenuation and CV death
timeFrame: 7 years
measure: PCAT attenuation and PAD
timeFrame: 7 years
measure: PCAT attenuation and CV revascularization
timeFrame: 7 years
measure: PCAT attenuation and all-cause mortality
timeFrame: 7 years
measure: Changes in PCAT attenuation and non-fatal acute myocardial infarction
timeFrame: 7 years
measure: Changes in PCAT attenuation and hospitalization for HF
timeFrame: 7 years
measure: Changes in PCAT attenuation and non-fatal stroke
timeFrame: 7 years
measure: Changes in PCAT attenuation and PAD
timeFrame: 7 years
measure: Changes in PCAT attenuation and CV death
timeFrame: 7 years
measure: Changes in PCAT attenuation and CV revascularization
timeFrame: 7 years
measure: Changes in PCAT attenuation and all-cause mortality
timeFrame: 7 years
measure: Changes in PCAT attenuation and de novo heart failure
timeFrame: 7 years
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: Cardiovascular Research Unit
state: South Denmark
Study officials:
affiliation: Odense University Hospital - Svendborg
name: Kenneth Egstrup, Professor
role: PRINCIPAL_INVESTIGATOR
References: