Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial I… (NCT05619042) | Clinical Trial Compass
CompletedNot Applicable
Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms
Argentina800 participantsStarted 2022-11-07
Plain-language 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?
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion Criteria:
* Men and women between 30 and 75 years attending the institution for a non-contrast cardiac CT scan (coronary calcium score) either by medical indication or voluntary for cardiovascular risk assessment.
* Signature of the informed consent form
Exclusion Criteria:
* Previously known chronic renal or hepatic insufficiency.
* Active chronic lung disease, defined as exacerbated asthma, exacerbated chronic obstructive pulmonary disease (COPD), or pulmonary fibrosis.
* Active and/or previous cardiovascular disease, defined as previous acute myocardial infarction, stable or unstable angina, cerebrovascular accident, history of vascular interventions (coronary or another territory), heart failure, severe cardiomyopathies, or valvulopathies.
* Uncontrolled hyper or hypothyroidism.
* Suprarenal insufficiency.
* Previous surgeries in the last 3 months.
* Severe trauma in the last 6 months, defined as one that involved bone fractures and/or surgical interventions.
* Known active cancer disease or under treatment (acute or preventive), or history of cancer disease without criteria for a cure.
* Known autoimmune disease active or in treatment.
* Ongoing pregnancy, postpartum period of fewer than 12 months, or breastfeeding.
* Other serious illnesses with an estimated life expectancy of fewer than 12 months (according to the investigators).
* Temperature greater than 37.5°C recorded by a thermometer or any acute infection caused by viruses or bacteria confirmed by a …
What they're measuring
1
Coronary artery calcium score
Timeframe: At baseline (cross-sectional assessment)