Atherosclerosis Clinical Trial
— CARPEDIEMOfficial title:
Coronary Artery Plaque Burden in Type 2 Diabetes Mellitus. Changes Over Time, Relation to Risk Profile, and Comparison to Acute Myocardial Infarction.
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.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | September 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | University Hospital of Odense (OUH) Svendborg Hospital | Svendborg | Fyn |
Lead Sponsor | Collaborator |
---|---|
Svendborg Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in plaque burden stratified by diabetic complications. | Changes in plaque burden (percentage) during 12 months in diabetics with or without diabetic complications. | Baseline,12 months. | No |
Primary | 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) | Baseline, 12 months | No |
Primary | 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. | Baseline, 12 months | No |
Primary | Changes in plaque morphology stratified by cardiovascular risk factors. | Changes in plaque burden during 12-months stratified by cardiovascular risk factors | Baseline,12 months | No |
Secondary | 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. | Baseline and 12 months | No |
Secondary | 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. | Baseline,12-months | No |
Secondary | 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. | Baseline,12-months | No |
Secondary | 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. | Baseline,12-months | No |
Secondary | 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. |
5-7 years | No |
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