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

Svendborg Hospital

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT03016910

CD20150029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

350 participants in 2 patient groups

Type 2 diabetes

Description:

This group will consist of 300 patients with type 2 diabetes mellitus without symptoms or known coronary heart disease. The group will be followed for one year and CCTA will be performed at baseline and after one year.

Type 1 diabetes

Description:

This group will consist of 50-100 patients with type 1 diabetes mellitus without symptoms or known coronary heart disease. The group will be followed for one year. CCTA will be performed at baseline and after one year.