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

Atherosclerosis Clinical Trial

— CARPEDIEM  

Official title:

Coronary Artery Plaque Burden in Type 2 Diabetes Mellitus. Changes Over Time, Relation to Risk Profile, and Comparison to Acute Myocardial Infarction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03016910
• Other study ID #: CD20150029
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2017
• Last updated: January 8, 2017
• Start date: March 2016
• Est. completion date: September 2019

Study information

• Verified date: January 2017
• Source: Svendborg Hospital
• Contact: Laurits J Heinsen, MD
• Phone: +4563202429
• Email: lauritsheinsen[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: September 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Computed Tomography Angiography
• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Microalbuminuria
• Plaque Vulnerability
• Plaque, Atherosclerotic
• Type2 Diabetes

Locations

Country	Name	City	State
Denmark	University Hospital of Odense (OUH) Svendborg Hospital	Svendborg	Fyn

Sponsors (1)

Lead Sponsor	Collaborator
Svendborg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plaque burden stratified by diabetic complications.	Changes in plaque burden (percentage) during 12 months in diabetics with or without diabetic complications.	Baseline,12 months.	No
Primary	Changes in plaque burden stratified by cardiovascular risk factors	Changes in plaque burden during 12 months stratified by cardiovascular risk factors (hypertension,hypercholersterolemia, smoking, overweight/obesity)	Baseline, 12 months	No
Primary	Changes in plaque morphology stratified by diabetic complications	Changes in plaque morphology (PR, LAP, NRS, SC) during 12 months in diabetics either with or without diabetic complications.	Baseline, 12 months	No
Primary	Changes in plaque morphology stratified by cardiovascular risk factors.	Changes in plaque burden during 12-months stratified by cardiovascular risk factors	Baseline,12 months	No
Secondary	Changes in plaque burden in diabetes compared to AMI-patients without diabetes.	A comparison of plaque burden (percentage) in diabetes and a historical cohort of AMI-patients.	Baseline and 12 months	No
Secondary	Changes in plaque morphology in diabetes compared to AMI-patients without diabetes.	A comparison of plaque morphology in diabetes and a historical cohort of AMI-patients.	Baseline,12-months	No
Secondary	Changes in plaque burden during 12 months in relation to HbA1c and cholesterol levels.	Changes in plaque burden during 12 months stratified by historical levels of cholesterol and HbA1c levels recorded from onset of diabetes to present.	Baseline,12-months	No
Secondary	Changes in plaque morphology during 12 months in relation to HbA1c and cholesterol levels.	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.	Baseline,12-months	No
Secondary	Impact of asymtomatic CAD in diabetes on future events.	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.	5-7 years	No