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NOT YET RECRUITING
NCT06439719

Plaque Composition in T2DM With and Without Microvascular Complications

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

Official title: Differences in Plaque Composition Evaluated Through Coronary Tomography in Subjects With Type 2 Diabetes With and Without Microvascular Complications

Key Details

Gender

All

Age Range

40 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

244

Start Date

2024-05-27

Completion Date

2026-05-27

Last Updated

2024-06-03

Healthy Volunteers

No

Interventions

PROCEDURE

Blood sample collection

Collection of blood sample