Atherosclerosis, CoronaryPCAT-DMNCT06644651

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

An observational study of Atherosclerosis, Coronary and Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Atherosclerosis, Coronary, Diabetes Mellitus, Diabetes Mellitus Type 2
How many people: 314 participants
Where: 1 siteDenmark
Study dates: 1 Mar 2016to 1 Mar 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Cardiovascular Research Unit
Svendborg, Region Syddanmark, 5700

Other trials in Denmark

About this study

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

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)

Read the 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.

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
Medical subject headings: Coronary Artery Disease, Diabetes Mellitus, Diabetes Mellitus, Type 2, Inflammation, Plaque, Atherosclerotic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06644651
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 7 years

Secondary outcomes (16)

PCAT attenuation and de novo heart failure
Baseline PCAT attenuation will be used to predict de novo heart failure over a 7-year period following the CCTA scan.
Measured: 7 years
PCAT attenuation and non-fatal acute myocardial infarction
Baseline PCAT attenuation will be used to predict non-fatal acute myocardial infarction (AMI) over a 7-year period following the CCTA scan.
Measured: 7 years
PCAT attenuation and non-fatal stroke
Baseline PCAT attenuation will be used to predict non-fatal stroke over a 7-year period following the CCTA scan.
Measured: 7 years
PCAT attenuation and hospitalization for HF
Baseline PCAT attenuation will be used to predict hospitalization for heart failure (HF) over a 7-year period following the CCTA scan.
Measured: 7 years
PCAT attenuation and CV death
Baseline PCAT attenuation will be used to predict cardiovascular (CV) death over a 7-year period following the CCTA scan.
Measured: 7 years
PCAT attenuation and PAD
Baseline PCAT attenuation will be used to predict peripheral artery disease (PAD) over a 7-year period following the CCTA scan.
Measured: 7 years
PCAT attenuation and CV revascularization
Baseline PCAT attenuation will be used to predict CV (cardiovascular) revascularization over a 7-year period following the CCTA scan.
Measured: 7 years
PCAT attenuation and all-cause mortality
Baseline PCAT attenuation will be used to predict all-cause mortality over a 7-year period following the CCTA scan.
Measured: 7 years
Changes in PCAT attenuation and non-fatal acute myocardial infarction
Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict non-fatal acute myocardial infarction (AMI) over a 7-year period following the baseline CCTA scan.
Measured: 7 years
Changes in PCAT attenuation and hospitalization for HF
Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict hospitalization for heart failure (HF) over a 7-year period following the baseline CCTA scan.
Measured: 7 years
Changes in PCAT attenuation and non-fatal stroke
Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict non-fatal stroke over a 7-year period following the baseline CCTA scan.
Measured: 7 years
Changes in PCAT attenuation and PAD
Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict peripheral artery diasease (PAD) over a 7-year period following the baseline CCTA scan.
Measured: 7 years
Changes in PCAT attenuation and CV death
Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict cardiovascular (CV) death over a 7-year period following the baseline CCTA scan.
Measured: 7 years
Changes in PCAT attenuation and CV revascularization
Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict cardiovascular (CV) revascularization over a 7-year period following the baseline CCTA scan.
Measured: 7 years
Changes in PCAT attenuation and all-cause mortality
Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict all-cause mortality, over a 7-year period following the baseline CCTA scan.
Measured: 7 years
Changes in PCAT attenuation and de novo heart failure
Changes in PCAT attenuation from baseline to the 12-month CCTA scan will be used to predict de novo heart failure (HF) over a 7-year period following the baseline CCTA scan.
Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20161 Mar 2025

First posted16 Oct 2024
Study start1 Mar 2016
Primary completionFeb 2025
Study completion1 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atherosclerosis, CoronaryStudies of the same condition, open and under way.
More trials run by Odense University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 314 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06644651
Sponsor's protocol ID: PCAT-DM
Acronym: PCAT-DM
Status last verified: Jul 2025
First submitted: 15 Oct 2024
Last updated: 31 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40155929

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06644651
Acronym / sponsor ID: PCAT-DM / PCAT-DM
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
Study type: Observational
Recruitment status: Completed
Enrolment: 314 participants (actual)
Lead sponsor: Odense University HospitalUniversity, hospital or other
Study start: 1 Mar 2016 (actual)
Primary completion: Feb 2025 (actual)
Study completion: 1 Mar 2025 (actual)
First posted: 16 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Setting and study population:

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Baseline PCAT attenuation and plaque features at the 12-month CCTA
Time frame: 12 months
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).
Changes in PCAT attenuation and plaque features at the 12-month CCTA
Time frame: 12 months
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).
Baseline PCAT attenuation and MACE
Time frame: 7 years
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.
Changes in PCAT attenuation after 12-month and MACE
Time frame: 7 years
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.

16 secondary outcomes

PCAT attenuation and de novo heart failure
Time frame: 7 years
PCAT attenuation and non-fatal acute myocardial infarction
Time frame: 7 years
PCAT attenuation and non-fatal stroke
Time frame: 7 years
PCAT attenuation and hospitalization for HF
Time frame: 7 years
PCAT attenuation and CV death
Time frame: 7 years
PCAT attenuation and PAD
Time frame: 7 years
PCAT attenuation and CV revascularization
Time frame: 7 years
PCAT attenuation and all-cause mortality
Time frame: 7 years
Changes in PCAT attenuation and non-fatal acute myocardial infarction
Time frame: 7 years
Changes in PCAT attenuation and hospitalization for HF
Time frame: 7 years
Changes in PCAT attenuation and non-fatal stroke
Time frame: 7 years
Changes in PCAT attenuation and PAD
Time frame: 7 years
Changes in PCAT attenuation and CV death
Time frame: 7 years
Changes in PCAT attenuation and CV revascularization
Time frame: 7 years
Changes in PCAT attenuation and all-cause mortality
Time frame: 7 years
Changes in PCAT attenuation and de novo heart failure
Time frame: 7 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
Derived from this study: PubMed 40155929Overgaard 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kenneth Egstrup, Professor principal investigator

Odense University Hospital - Svendborg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis, Coronary and Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline PCAT attenuation and plaque features at the 12-month CCTA (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06644651, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.