Clinical trial NCT05619042: Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms
Official title: Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms. (CAC-TRAIT Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Atheroscleroses, Coronary
Atherosclerotic Plaque
Keywords: risk stratification
Cardiovascular disease (CVD) screening
general population
transcriptomics
primary prevention
artificial intelligence
no history of CVD
subclinical
Lead sponsor: MultiplAI Health Limited
Sponsor class: OTHER
Collaborators: name: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
First posted: 2022-11-16
Enrollment: 800
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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 health professional in the previous 30 days.
* Pathologies under immunosuppressive treatment

Primary outcomes:
measure: Coronary artery calcium score
timeFrame: At baseline (cross-sectional assessment)
Secondary outcomes:
measure: Coronary artery calcium score
timeFrame: At baseline (cross-sectional assessment)
measure: Coronary artery calcium score (number of segments)
timeFrame: At baseline (cross-sectional assessment)
measure: Aortic valve calcium
timeFrame: At baseline (cross-sectional assessment)
measure: Thoracic aorta calcium
timeFrame: At baseline (cross-sectional assessment)
measure: Epicardial adipose tissue (volume)
timeFrame: At baseline (cross-sectional assessment)
measure: Epicardial adipose tissue (density)
timeFrame: At baseline (cross-sectional assessment)
measure: Fatty liver
timeFrame: At baseline (cross-sectional assessment)
measure: Neutrophil to lymphocyte ratio
timeFrame: At baseline (cross-sectional assessment)
measure: High-sensitive C reactive protein (CRP)
timeFrame: At baseline (cross-sectional assessment)
measure: Repolarization abnormalities
timeFrame: At baseline (cross-sectional assessment)
measure: Left ventricular hypertrophy
timeFrame: At baseline (cross-sectional assessment)
measure: Intraventricular conduction abnormalities
timeFrame: At baseline (cross-sectional assessment)
measure: Percent electron density relative to water (%EDW)
timeFrame: At baseline (cross-sectional assessment)
measure: Death
timeFrame: year 1 through 5
measure: Acute ischemic syndrome
timeFrame: year 1 through 5
measure: Heart failure
timeFrame: year 1 through 5
measure: Vascular revascularization
timeFrame: year 1 through 5
measure: cerebrovascular event
timeFrame: year 1 through 5
measure: Cancer
timeFrame: year 1 through 5
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Clinica Sagrada Familia
Study officials:
affiliation: MultiplAI Health LTD
name: Santiago G Miriuka, MD MSc PhD
role: PRINCIPAL_INVESTIGATOR
References: