NCT05619042Completed
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)
Source: ClinicalTrials.gov · Last updated 20 Mar 2024
Brief summary (registry, in English)
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?
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 800 (actual)
- First submitted
- 1 Nov 2022
- Start date
- 7 Nov 2022
- Primary completion date
- 24 Jan 2024
- Lead sponsor
- Santiago Gabriel Miriuka
- Diseases
- Coronary artery disease
- NCT number
- NCT05619042
What you commit to
- Study type: Observational
- Participants enrolled: 800
- From 7 Nov 2022 to the primary completion date, 24 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously known chronic renal or hepatic insufficiency.
- 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.
- 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.
- Temperature greater than 37.5°C recorded by a thermometer or any acute infection caused by viruses or bacteria confirmed by a health professional in the previous 30 days.
Other illness
- Active chronic lung disease, defined as exacerbated asthma, exacerbated chronic obstructive pulmonary disease (COPD), or pulmonary fibrosis.
- Suprarenal insufficiency.
- 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.
- Other serious illnesses with an estimated life expectancy of fewer than 12 months (according to the investigators).
Other
- Uncontrolled hyper or hypothyroidism.
- Ongoing pregnancy, postpartum period of fewer than 12 months, or breastfeeding.
- Pathologies under immunosuppressive treatment
Who the study is looking for
- 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
Age in the registry: 30 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Sagrada Familia Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.