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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.


Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT03016910
Study type Observational
Source Svendborg Hospital
Contact Laurits J Heinsen, MD
Phone +4563202429
Email lauritsheinsen@gmail.com
Status Recruiting
Phase N/A
Start date March 2016
Completion date September 2019

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