Clinica Sagrada Familia
Buenos Aires, C1426EOB, Argentina
NCT Number: NCT05619042
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?
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Notify Me30 year–75 year
All sexes
Observational
Buenos Aires, C1426EOB, Argentina
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At baseline (cross-sectional assessment)
Coronary artery calcium (CAC) score (Agatston units) stratified with increasing risk according to the Society of Cardiovascular Computed Tomography Guidelines as CAC=0; CAC 1-99; CAC 100-299; and CAC≥300.
Time frame: At baseline (cross-sectional assessment)
Percentile Agatston score: according to age and sex with a increasing risk ranging from 1 to 99 th percentile.
Time frame: At baseline (cross-sectional assessment)
Number of segments with coronary calcifications ranging from 0 to 17 segments.
Time frame: At baseline (cross-sectional assessment)
Aortic valve calcification score (Agatston units) as a continuous variable with increasing risk and without preestablished thresholds
Time frame: At baseline (cross-sectional assessment)
Thoracic aorta calcification score (Agatston units) as a continuous variable with increasing risk and without preestablished thresholds
Time frame: At baseline (cross-sectional assessment)
cm2/m2
Time frame: At baseline (cross-sectional assessment)
density, Q1-Q4: quartiles percentage
Time frame: At baseline (cross-sectional assessment)
liver attenuation <48 Hounsfield units
Time frame: At baseline (cross-sectional assessment)
hematological parameter for systemic inflammation and stress
Time frame: At baseline (cross-sectional assessment)
mg/dl
Time frame: At baseline (cross-sectional assessment)
Number of participants with repolarization abnormalities on a 12-lead ECG, defined as ST segment depression or pathological T wave inversion.
Time frame: At baseline (cross-sectional assessment)
Number of participants with left ventricular hypertrophy on a 12-lead ECG, defined by positive Sokolow-Lyon or Cornell criteria.
Time frame: At baseline (cross-sectional assessment)
Number of participants with intraventricular conduction abnormalities on a 12-lead ECG, stratified by the presence of left bundle branch
block; right bundle branch block and left posterior fascicular block; right bundle branch block and left anterior fascicular block or right bundle branch block; or left anterior fascicular block.
Time frame: At baseline (cross-sectional assessment)
percent electron density relative to water, available for direct evaluation with dedicated software in all scans acquired using a dual-layer spectral CT scanner).
Time frame: year 1 through 5
Number of participants with report of death from any cause
Time frame: year 1 through 5
Number of participants with non fatal diagnosis of acute myocardial infarction or unstable angina
Time frame: year 1 through 5
Number of participants with non fatal new diagnosis of heart failure with preserved or impaired ventricular function
Time frame: year 1 through 5
Number of participants with performance of myocardial revascularization surgery, coronary angioplasty or peripheral vascular angioplasty
Time frame: year 1 through 5
Number of participants with non fatal diagnosis of cerebrovascular accident ("stroke") or transient ischemic attack
Time frame: year 1 through 5
Number of participants with new diagnosis of any type of cancer
Santiago Gabriel Miriuka
Other
Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms. (CAC-TRAIT Study)
Acronym: CAC-TRAIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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