Clinical trial NCT03016910: Coronary Artery Plaque Burden and Morphology in Type 2 Diabetes Mellitus.
Official title: Coronary Artery Plaque Burden in Type 2 Diabetes Mellitus. Changes Over Time, Relation to Risk Profile, and Comparison to Acute Myocardial Infarction.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type2 Diabetes
Atherosclerosis
Plaque, Atherosclerotic
Plaque Vulnerability
Diabetes Complications
Microalbuminuria
Coronary Computed Tomography Angiography
Lead sponsor: Svendborg Hospital
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 1 or 2 diabetes mellitus without history of CAD or relevant symptoms (angina). Patients are recruited at the out-patient clinic at Svendborg Hospital.

Brief summary: Unstable plaque, the primary cause of myocardial infarction, is characterized by distinct a morphology including positive remodeling (PR), low attenuated plaque (LAP), napkin ring sign (NRS), and spotty calcifications (SC) The purpose of the present study is to investigate the influence of microvascular dysfunction and additional risk factors on plaque morphology and plaque burden in patients with diabetes mellitus.

Detailed description: Coronary artery disease (CAD) is the leading cause of death and morbidity in type 2 diabetes mellitus (T2DM) and diabetics holds the same risk for death or myocardial infarction (MI) as patients with a prior (MI) without diabetes. In addition to macrovascular complications, and traditional cardiac risk factors, T2DM is burdened by microvascular dysfunction affecting several organs. The dynamics between microvascular dysfunction, known cardiac risk factors and coronary atherosclerosis in diabetic disease is not well characterized.

In the present study, a primary cohort of 300 type 2 diabetics and a subgroup of 50-100 type 1 diabetics will be examined with CCTA at baseline and after one year. In addition, CAD in diabetes will be compared to a historical cohort of patients with acute myocardial infarction (AMI).

All study participant will undergo the following examinations at baseline:

* CCTA
* CAC-score
* Transthoracic echocardiography
* 12-lead ECG
* 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 will be repeated.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Type 1 or 2 diabetes mellitus
* Ability to provide informed conscent

Exclusion Criteria:

* History of CAD
* Symtoms of CAD (angina)
* Any tachyarrhythmias making CCTA impossible
* Glumerular filtration rate (GFR)\< 45 ml/min
* Allergy to iodine contrast
* Critical illness with life expectancy less than 1 year
* Documented heart failure

Primary outcomes:
measure: Changes in plaque burden stratified by diabetic complications.
timeFrame: Baseline,12 months.
measure: Changes in plaque burden stratified by cardiovascular risk factors
timeFrame: Baseline, 12 months
measure: Changes in plaque morphology stratified by diabetic complications
timeFrame: Baseline, 12 months
measure: Changes in plaque morphology stratified by cardiovascular risk factors.
timeFrame: Baseline,12 months
Secondary outcomes:
measure: Changes in plaque burden in diabetes compared to AMI-patients without diabetes.
timeFrame: Baseline and 12 months
measure: Changes in plaque morphology in diabetes compared to AMI-patients without diabetes.
timeFrame: Baseline,12-months
measure: Changes in plaque burden during 12 months in relation to HbA1c and cholesterol levels.
timeFrame: Baseline,12-months
measure: Changes in plaque morphology during 12 months in relation to HbA1c and cholesterol levels.
timeFrame: Baseline,12-months
measure: Impact of asymtomatic CAD in diabetes on future events.
timeFrame: 5-7 years
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: University Hospital of Odense (OUH) Svendborg Hospital
state: Fyn
Study officials:
affiliation: Head of Reseach, Cardiovascular Research Unit, OUH Svendborg Hospital
name: Kenneth Egstrup, Prof. DMSci
role: STUDY_DIRECTOR
References:
citation: Heinsen LJ, Pararajasingam G, Andersen TR, Auscher S, Sheta HM, Precht H, Lambrechtsen J, Egstrup K. High-risk coronary artery plaque in asymptomatic patients with type 2 diabetes: clinical risk factors and coronary artery calcium score. Cardiovasc Diabetol. 2021 Aug 9;20(1):164. doi: 10.1186/s12933-021-01350-2.