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.
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 Type
OBSERVATIONAL
Enrollment
350
University Hospital of Odense (OUH) Svendborg Hospital
Svendborg, Fyn, Denmark
RECRUITINGChanges in plaque burden stratified by diabetic complications.
Changes in plaque burden (percentage) during 12 months in diabetics with or without diabetic complications.
Time frame: Baseline,12 months.
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)
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
Changes in plaque morphology stratified by cardiovascular risk factors.
Changes in plaque burden during 12-months stratified by cardiovascular risk factors
Time frame: Baseline,12 months
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.
Time frame: Baseline and 12 months
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.
Time frame: Baseline,12-months
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.
Time frame: Baseline,12-months
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.
Time frame: Baseline,12-months
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.
Time frame: 5-7 years
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