NCT05619042

Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms

Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms. (CAC-TRAIT Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: Santiago Gabriel Miriuka · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to determine the diagnostic accuracy of peripheral whole blood transcriptomes analyzed by an artificial intelligence algorithm to detect the presence and extent of coronary calcification in individuals without a history of known cardiovascular disease. The main question it aims to answer is: 1\. Will the proposed method predict the presence and extent of coronary artery calcification from the peripheral whole-blood transcriptomes?

Detailed description

This study will be a prospective observational single-site study. A convenience sample will be carried out to include 800 patients who attend the Clinic, to undergo a cardiac CT without contrast (coronary calcium score), either for a medical indication or volunteers for an assessment of cardiovascular risk. The study will have a baseline stage in which a clinical evaluation will be performed, blood samples will be drawn for transcriptome analysis and laboratory analysis. Then, a DNA sample obtained by swabbing the buccal mucosa will be taken. Subsequently, a non-contrast gated cardiac CT will be performed to assess the presence and extent of coronary calcification and other outcomes of interest. At the end of patient enrollment, biological samples will be sequenced for in silico evaluation of the results. Finally, a 5-year clinical (telephone) follow-up will be carried out to collect data on the incidence of fatal and non-fatal cardiovascular events.

Conditions

• Atherosclerosis
• Atheroscleroses, Coronary
• Atherosclerotic Plaque

Timeline

• Start date: 2022-11-07
• Primary completion: 2024-01-24
• Completion: 2024-01-24
• First posted: 2022-11-16
• Last updated: 2024-03-20

Locations

1 site across 1 country: Argentina