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

S

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.

Trial contacts and locations

0

Loading...

Central trial contact

Kenneth Egstrup, Prof. DMSci; Laurits J Heinsen, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems