Viewing Study NCT05619042



Ignite Creation Date: 2024-05-06 @ 6:18 PM
Last Modification Date: 2024-10-26 @ 2:45 PM
Study NCT ID: NCT05619042
Status: COMPLETED
Last Update Posted: 2024-03-20
First Post: 2022-11-01

Brief Title: Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms
Sponsor: Santiago Gabriel Miriuka
Organization: MultiplAI Health Limited

Study Overview

Official Title: Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms CAC-TRAIT Study
Status: COMPLETED
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CAC-TRAIT
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None