Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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
Type2 Diabetes Atherosclerosis Plaque, Atherosclerotic Plaque Vulnerability Diabetes Complications Microalbuminuria Coronary Computed Tomography Angiography

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coronary Artery Plaque Burden in Type 2 Diabetes Mellitus. Changes Over Time, Relation to Risk Profile, and Comparison to Acute Myocardial Infarction.
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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)

  3. 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.

  4. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Biospecimen Retention:   Samples With DNA

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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016910


Contacts
Layout table for location contacts
Contact: Laurits J Heinsen, MD +4563202429 lauritsheinsen@gmail.com
Contact: Kenneth Egstrup, Prof. DMSci +4563202402 kenneth.egstrup@rsyd.dk

Locations
Layout table for location information
Denmark
University Hospital of Odense (OUH) Svendborg Hospital Recruiting
Svendborg, Fyn, Denmark, 5700
Contact: Laurits J Heinsen, MD    +4563202429    lauritsheinsen@gmail.com   
Contact: kenneth Egstrup, Prof. DMSci    +4563202402    kenneth.egstrup@rsyd.dk   
Principal Investigator: Laurits J Heinsen, MD         
Sponsors and Collaborators
Svendborg Hospital
Investigators
Layout table for investigator information
Study Director: Kenneth Egstrup, Prof. DMSci Head of Reseach, Cardiovascular Research Unit, OUH Svendborg Hospital
Layout table for additonal information
Responsible Party: Laurits Heinsen, Medical doctor, Svendborg Hospital
ClinicalTrials.gov Identifier: NCT03016910    
Other Study ID Numbers: CD20150029
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Atherosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Plaque, Atherosclerotic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases