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

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ClinicalTrials.gov Identifier: NCT03016910
Recruitment Status : Unknown
Verified January 2017 by Laurits Heinsen, Svendborg Hospital.
Recruitment status was:  Recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Laurits Heinsen, Svendborg Hospital

Tracking Information
First Submitted Date January 2, 2017
First Posted Date January 11, 2017
Last Update Posted Date January 11, 2017
Study Start Date March 2016
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2017)
  • Changes in plaque burden stratified by diabetic complications. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: Baseline,12 months ]
    Changes in plaque burden during 12-months stratified by cardiovascular risk factors
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 8, 2017)
  • Changes in plaque burden in diabetes compared to AMI-patients without diabetes. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Coronary Artery Plaque Burden and Morphology in Type 2 Diabetes Mellitus.
Official Title Coronary Artery Plaque Burden in Type 2 Diabetes Mellitus. Changes Over Time, Relation to Risk Profile, and Comparison to Acute Myocardial Infarction.
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.
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:

  • 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

Blood samples will be stored at -80 degrees celcius for a biobank. These includes:

5 x 2 ml (serum).

4 x 2 ml (ethylenediaminetetraacetic acid "EDTA").

2 x 2 ml (sodium citrate)

1 x 2 ml (buffy coat)

Sampling Method Non-Probability Sample
Study Population Patients with type 1 or 2 diabetes mellitus without history of CAD or relevant symptoms (angina). Patients are recruited at the out-patient clinic at Svendborg Hospital.
Condition
  • Type2 Diabetes
  • Atherosclerosis
  • Plaque, Atherosclerotic
  • Plaque Vulnerability
  • Diabetes Complications
  • Microalbuminuria
  • Coronary Computed Tomography Angiography
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 8, 2017)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03016910
Other Study ID Numbers CD20150029
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Laurits Heinsen, Svendborg Hospital
Study Sponsor Svendborg Hospital
Collaborators Not Provided
Investigators
Study Director: Kenneth Egstrup, Prof. DMSci Head of Reseach, Cardiovascular Research Unit, OUH Svendborg Hospital
PRS Account Svendborg Hospital
Verification Date January 2017