CARPEDIEM: Coronary Artery Plaque Burden and Morphology in Type 2 Diabetes Mellitus.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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:
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CCTA
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CAC-score
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Transthoracic echocardiography
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12-lead ECG
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Blood pressure and pulse frequency
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Height, weight, waist to hip-ratio
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Blood samples and urin samples
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Medical history
After 12 months all of the above examinations will be repeated.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Type 2 diabetes 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 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. |
Outcome Measures
Primary Outcome Measures
- Changes in plaque burden stratified by diabetic complications. [Baseline,12 months.]
Changes in plaque burden (percentage) during 12 months in diabetics with or without diabetic complications.
- Changes in plaque burden stratified by cardiovascular risk factors [Baseline, 12 months]
Changes in plaque burden during 12 months stratified by cardiovascular risk factors (hypertension,hypercholersterolemia, smoking, overweight/obesity)
- Changes in plaque morphology stratified by diabetic complications [Baseline, 12 months]
Changes in plaque morphology (PR, LAP, NRS, SC) during 12 months in diabetics either with or without diabetic complications.
- Changes in plaque morphology stratified by cardiovascular risk factors. [Baseline,12 months]
Changes in plaque burden during 12-months stratified by cardiovascular risk factors
Secondary Outcome Measures
- Changes in plaque burden in diabetes compared to AMI-patients without diabetes. [Baseline and 12 months]
A comparison of plaque burden (percentage) in diabetes and a historical cohort of AMI-patients.
- Changes in plaque morphology in diabetes compared to AMI-patients without diabetes. [Baseline,12-months]
A comparison of plaque morphology in diabetes and a historical cohort of AMI-patients.
- Changes in plaque burden during 12 months in relation to HbA1c and cholesterol levels. [Baseline,12-months]
Changes in plaque burden during 12 months stratified by historical levels of cholesterol and HbA1c levels recorded from onset of diabetes to present.
- Changes in plaque morphology during 12 months in relation to HbA1c and cholesterol levels. [Baseline,12-months]
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.
- Impact of asymtomatic CAD in diabetes on future events. [5-7 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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Type 1 or 2 diabetes mellitus
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Ability to provide informed conscent
Exclusion Criteria:
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History of CAD
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Symtoms of CAD (angina)
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Any tachyarrhythmias making CCTA impossible
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Glumerular filtration rate (GFR)< 45 ml/min
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Allergy to iodine contrast
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Critical illness with life expectancy less than 1 year
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Documented heart failure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Odense (OUH) Svendborg Hospital | Svendborg | Fyn | Denmark | 5700 |
Sponsors and Collaborators
- Svendborg Hospital
Investigators
- Study Director: Kenneth Egstrup, Prof. DMSci, Head of Reseach, Cardiovascular Research Unit, OUH Svendborg Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CD20150029