Coronary Artery Plaque Burden in Asymptomatic Danish Men Aged 65-75 Years and the Relation to Glycemic Status.

NCT04525508 | Completed

• 1 other identifier: 01
• Study Type: observational
• Target: 488
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease (CVD) is one of the leading causes of death in the Western Society. Patients with type 2 diabetes mellitus (T2DM) or dysglycemia have an increased risk of developing CVD. Furthermore, T2DM have an increased risk of developing heart failure, especially non-systolic, whether or not this is correlated to stepwise abnormal glycemic status is not fully investigated. The aims of this study are to investigate association between 1) Coronary plaque burden and morphology to glycemic status (normal glucose tolerance (NGT), dysglycemia (impaired fasting glucose (IFG) or impaired glucose tolerance (IGT)) and diabetic oral glucose tolerance test (OGTT) in participants without known T2DM), 2) Coronary plaque burden and morphology to diastolic and systolic function of the left ventricle including 2D speckle-tracking assessments, 3) Glycemic status to diastolic and systolic function of the left ventricle including 2D speckle-tracking assessments In this descriptive study, 500-800 asymptomatic men aged 65-75 without known diabetes will be included and divided into three subpopulations according to glycemic status. Blood sample, oral glucose tolerance test (OGTT), echocardiography and Coronary CT Angiography (CCTA) will be performed at inclusion

Conditions

Coronary Artery Disease; Dysglycemia

Outcome Measures

Primary Outcomes (1)

• Correlation between glycemic status to coronary plaque burden and morphology.

  To evaluate the correlation between glycemic status (NGT, dysglycemia or Diabetic OGTT in patients without known T2DM) to plaque burden and morphology in asymptomatic men, aged 65-75 years. Plaque burden analyzed per vessel is defined as either percent atheroma volume (PAV), total atheroma volume (TAV) or normalized atheroma volume (NAV). Plaque morphology will include per plaque analysis of LAP (noncalcified plaque), remodeling indices (RI), spotty calcification and degree of stenosis where a significant stenosis is defined as \>70 % of the luminal area. Above mentioned definitions of plaque burden and morphology is further explained in detail in Study Description above.

  Baseline

Secondary Outcomes (2)

• Association between coronary artery plaque burden and morphology to diastolic and systolic function of the left ventricle.

  Baseline

• Association between glycemic status to diastolic and systolic function of the left ventricle.

  Baseline

Other Outcomes (8)

• Association between insulin resistance to coronary artery plaque burden and morphology.

  Baseline

• Correlation between insulin resistance to diastolic and systolic function of the left ventricle.

  Baseline

• Correlation between inflammatory biomarkers eg. TNF-alpha and Hs-CRP to coronary artery plaque burden and morphology.

  Baseline

Study Arms (3)

Normal glucose tolerance (NGT)

Those of the study population with one normal Oral glucose tolerance test (OGTT)

Dysglycemia

Those of the study population with one dysglycemia (IFG and/or IGT)

Diabetic OGTT

Those of the study population with one Diabetic OGTT

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit participants from the DANCAVAS study. The DANCAVAS study will include 45.000 men aged 65-74 years. 15.000 of the participants will be randomly selected to CCTA (non-contrast) and the resulting 30.000 constitutes the control group. The CCTA will be performed in four Danish cities. Our study will include 500-800 of those DANCAVAS participants who will undergo CCTA in OUH Svendborg Hospital. In our study we will perform following examination in addition to the examinations in the DANCAVAS study: one CCTA (contrast enhanched), one echocardiography and one OGTT.

You may qualify if:

• years
• Capable of giving written informed consent
• Participates in the DANCAVAS study

You may not qualify if:

• Body mass index (BMI) \>35
• Atrial fibrillation and other tachyarrhythmia that unable CCTA analysis
• Estimates Glomerular filtration rate (eGFR) \<45 ml/min
• Contrast allergy
• Untreated hyperthyroid
• History of CAD or Apoplexia
• Symptoms of CAD
• Known Diabetes Mellitus

Sponsors & Collaborators

• Svendborg Hospital: lead
• Odense University Hospital: collaborator

Study Sites (1)

Cardiovascular Research Unit, OUH Svendborg Hospital

Svendborg, DK:5700, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Storage in biobank (-80° C): 5 x 2 ml (serum). 4 x 2 ml (ethylenediaminetetraacetic acid). 2 x 2 ml (sodium citrate) 1 x 2 ml (erythrocyte sedimentation rate)

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Johanna Larsson, MD

  Svendborg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Johanna Larsson, Svendborg Hospital

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 25, 2020
• Study Start: May 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)