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

NCT03016910 | Unknown

• 1 other identifier: CD20150029
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

• 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

• 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

• Changes in plaque morphology stratified by cardiovascular risk factors.

  Changes in plaque burden during 12-months stratified by cardiovascular risk factors

  Baseline,12 months

Secondary Outcomes (5)

• Changes in plaque burden in diabetes compared to AMI-patients without diabetes.

  Baseline and 12 months

• Changes in plaque morphology in diabetes compared to AMI-patients without diabetes.

  Baseline,12-months

• Changes in plaque burden during 12 months in relation to HbA1c and cholesterol levels.

  Baseline,12-months

• Changes in plaque morphology during 12 months in relation to HbA1c and cholesterol levels.

  Baseline,12-months

• Impact of asymtomatic CAD in diabetes on future events.

  5-7 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 18 years
• Type 1 or 2 diabetes mellitus
• Ability to provide informed conscent

You may not qualify if:

• 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

Sponsors & Collaborators

• Svendborg Hospital: lead

Study Sites (1)

University Hospital of Odense (OUH) Svendborg Hospital

Svendborg, Fyn, 5700, Denmark

RECRUITING

Related Publications (1)

• Heinsen LJ, Pararajasingam G, Andersen TR, Auscher S, Sheta HM, Precht H, Lambrechtsen J, Egstrup K. High-risk coronary artery plaque in asymptomatic patients with type 2 diabetes: clinical risk factors and coronary artery calcium score. Cardiovasc Diabetol. 2021 Aug 9;20(1):164. doi: 10.1186/s12933-021-01350-2.

  PMID: 34372839 DERIVED

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)

MeSH Terms

Conditions

Atherosclerosis; Plaque, Atherosclerotic; Diabetes Complications

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Kenneth Egstrup, Prof. DMSci

  Head of Reseach, Cardiovascular Research Unit, OUH Svendborg Hospital

  STUDY DIRECTOR

Central Study Contacts

Laurits J Heinsen, MD

CONTACT

+4563202429; lauritsheinsen@gmail.com

Kenneth Egstrup, Prof. DMSci

CONTACT

+4563202402; kenneth.egstrup@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 11, 2017
• Study Start: March 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)