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Plaque Composition in T2DM With and Without Microvascular Complications

NCT06439719 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 244

Last updated 2024-06-03

No results posted yet for this study

Summary

Adults with diabetes mellitus have 2-3 times fold increased cardiovascular (CV) risk compared to adults without diabetes, and the risk rises with the worsening of glycaemic control. Adults with type 2 diabetes mellitus (T2DM) and microvascular complications (DMCs) have a higher risk of CV complications than subjects without DMCs. 2023 European Society of Cardiology (ESC) guidelines stated that individuals with T2DM with target organ damage (TOD), defined as presence of microvascular disease in at least three different sites (e.g., microalbuminuria (stage A2) plus retinopathy plus neuropathy), should be considered into a very high CV risk category.

Coronary artery calcium score (CACS) is a measure of the amount of calcium deposits in the coronary arteries obtained through a CT coronary imaging. CACS has become a widely available and accurate tool for determining the risk of major CV events.

The specific role of DMCs in determining the features of coronary plaques is not completely known. A recent study showed how T2DM subjects with obstructive coronary artery disease (CAD) with DMCs at their first coronary event present a more "stable" coronary atherosclerosis features at OCT-imaging, as they have a higher prevalence of fibrous plaques and healed plaques with larger calcifications compared to those with T2DM and no DMCs. In this study only subjects with obstructive CAD (defined as a stenosis ≥50% in the left main coronary artery or any stenosis ≥70% or fractional flow reserve \<0.80 in any other major epicardial vessel) were enrolled.

Therefore, further research to evaluate differences in CACS in T2DM subjects with no previous history of CAD with and without DMCs is required.

Aim of our study was to evaluate the presence of differences in the distribution and tomographic features of coronary plaques in T2DM subjects with no previous history of CAD with at least one DMCs, focusing on the degree of plaque calcification calculated by the CACS.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

PROCEDURE

Blood sample collection

Collection of blood sample

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-27
Primary Completion
2026-05-27
Completion
2026-05-27

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06439719 on ClinicalTrials.gov