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

January 8, 2017 updated by: Laurits Heinsen, Svendborg Hospital

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
    • Fyn
      • Svendborg, Fyn, Denmark, 5700
        • Recruiting
        • University Hospital of Odense (OUH) Svendborg Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laurits J Heinsen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline,12 months.
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)
Baseline, 12 months
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.
Baseline, 12 months
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
Baseline,12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 months
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.
Baseline,12-months
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.
Baseline,12-months
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.
Baseline,12-months
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.
5-7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Svendborg Hospital

Investigators

  • Study Director: Kenneth Egstrup, Prof. DMSci, Head of Reseach, Cardiovascular Research Unit, OUH Svendborg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 8, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 8, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD20150029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Complications

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe