Coronary Artery Plaque Burden and Morphology in Type 2 Diabetes Mellitus.

• Conditions: Type2 Diabetes; Plaque Vulnerability; Coronary Computed Tomography Angiography; Atherosclerosis; Diabetes Complications; Microalbuminuria; Plaque, Atherosclerotic

• Registration Number: NCT03016910
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2017-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-08
• Last Update Submitted: 2017-01-08
• Study First Posted: 2017-01-11
• Last Update Posted: 2017-01-11
• Primary Completion: 2019-03
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in plaque morphology stratified by cardiovascular risk factors.	Baseline,12 months	Changes in plaque burden during 12-months stratified by cardiovascular risk factors
Changes in plaque burden stratified by cardiovascular risk factors	Baseline, 12 months	Changes in plaque burden during 12 months stratified by cardiovascular risk factors (hypertension,hypercholersterolemia, smoking, overweight/obesity)
Changes in plaque burden stratified by diabetic complications.	Baseline,12 months.	Changes in plaque burden (percentage) during 12 months in diabetics with or without diabetic complications.
Changes in plaque morphology stratified by diabetic complications	Baseline, 12 months	Changes in plaque morphology (PR, LAP, NRS, SC) during 12 months in diabetics either with or without diabetic complications.

Secondary Outcome Measures

Name	Time	Method
Changes in plaque burden in diabetes compared to AMI-patients without diabetes.	Baseline and 12 months	A comparison of plaque burden (percentage) in diabetes and a historical cohort of AMI-patients.
Changes in plaque burden during 12 months in relation to HbA1c and cholesterol levels.	Baseline,12-months	Changes in plaque burden during 12 months stratified by historical levels of cholesterol and HbA1c levels recorded from onset of diabetes to present.
Changes in plaque morphology in diabetes compared to AMI-patients without diabetes.	Baseline,12-months	A comparison of plaque morphology in diabetes and a historical cohort of AMI-patients.
Changes in plaque morphology during 12 months in relation to HbA1c and cholesterol levels.	Baseline,12-months	Changes in plaque morphology during 12 months stratified by historical levels of cholesterol and HbA1c levels recorded once a year from onset of diabetes to present.
Impact of asymtomatic CAD in diabetes on future events.	5-7 years	Long term follow-up to evaluate the impact of asymptomatic CAD (plaque burden and morphology) in diabetes on death, coronary heart attack, hospitalization due to unstable angina, heart failure and ischemic stroke.; Clinical outcomes will be recorded from journal records and analyzed after 5-7 years.

Trial Locations

Locations (1)

University Hospital of Odense (OUH) Svendborg Hospital; 🇩🇰 Svendborg, Fyn, Denmark