AtherosclerosisCAC-TRAITNCT05619042
Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms
An observational study of Atherosclerosis and Atheroscleroses, Coronary, run by Santiago Gabriel Miriuka at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Atheroscleroses, Coronary, Atherosclerotic Plaque
- How many people
- 800 participants
- Where
- 1 siteArgentina
- Study dates
- 7 Nov 2022to 24 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms. (CAC-TRAIT Study)
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:
- Will the proposed method predict the presence and extent of coronary artery calcification from the peripheral whole-blood transcriptomes?
Read the 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.
- Keywords
- risk stratification, Cardiovascular disease (CVD) screening, general population, transcriptomics, primary prevention, artificial intelligence, no history of CVD, subclinical
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Plaque, Atherosclerotic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Presence / absence of CAC | Participants with or without a level/extension of CAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery calcium score
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.
Measured: At baseline (cross-sectional assessment)
Secondary outcomes (19)
Coronary artery calcium score
Percentile Agatston score: according to age and sex with a increasing risk ranging from 1 to 99 th percentile.
Measured: At baseline (cross-sectional assessment)
Coronary artery calcium score (number of segments)
Number of segments with coronary calcifications ranging from 0 to 17 segments.
Measured: At baseline (cross-sectional assessment)
Aortic valve calcium
Aortic valve calcification score (Agatston units) as a continuous variable with increasing risk and without preestablished thresholds
Measured: At baseline (cross-sectional assessment)
Thoracic aorta calcium
Thoracic aorta calcification score (Agatston units) as a continuous variable with increasing risk and without preestablished thresholds
Measured: At baseline (cross-sectional assessment)
Epicardial adipose tissue (volume)
cm2/m2
Measured: At baseline (cross-sectional assessment)
Epicardial adipose tissue (density)
density, Q1-Q4: quartiles percentage
Measured: At baseline (cross-sectional assessment)
Fatty liver
liver attenuation <48 Hounsfield units
Measured: At baseline (cross-sectional assessment)
Neutrophil to lymphocyte ratio
hematological parameter for systemic inflammation and stress
Measured: At baseline (cross-sectional assessment)
High-sensitive C reactive protein (CRP)
mg/dl
Measured: At baseline (cross-sectional assessment)
Repolarization abnormalities
Number of participants with repolarization abnormalities on a 12-lead ECG, defined as ST segment depression or pathological T wave inversion.
Measured: At baseline (cross-sectional assessment)
Left ventricular hypertrophy
Number of participants with left ventricular hypertrophy on a 12-lead ECG, defined by positive Sokolow-Lyon or Cornell criteria.
Measured: At baseline (cross-sectional assessment)
Intraventricular conduction abnormalities
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.
Measured: At baseline (cross-sectional assessment)
Percent electron density relative to water (%EDW)
percent electron density relative to water, available for direct evaluation with dedicated software in all scans acquired using a dual-layer spectral CT scanner).
Measured: At baseline (cross-sectional assessment)
Death
Number of participants with report of death from any cause
Measured: year 1 through 5
Acute ischemic syndrome
Number of participants with non fatal diagnosis of acute myocardial infarction or unstable angina
Measured: year 1 through 5
Heart failure
Number of participants with non fatal new diagnosis of heart failure with preserved or impaired ventricular function
Measured: year 1 through 5
Vascular revascularization
Number of participants with performance of myocardial revascularization surgery, coronary angioplasty or peripheral vascular angioplasty
Measured: year 1 through 5
cerebrovascular event
Number of participants with non fatal diagnosis of cerebrovascular accident ("stroke") or transient ischemic attack
Measured: year 1 through 5
Cancer
Number of participants with new diagnosis of any type of cancer
Measured: year 1 through 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start7 Nov 2022
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santiago Gabriel Miriuka
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
- Responsible party
- Sponsor-investigator, Santiago Gabriel Miriuka, MultiplAI Health Limited
- Investigators
- Santiago G Miriuka, MD MSc PhD, Principal investigator, MultiplAI Health LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619042
- Sponsor's protocol ID
- CCT2
- Acronym
- CAC-TRAIT
- Status last verified
- Mar 2024
- First submitted
- 1 Nov 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms. (CAC-TRAIT Study)
- ClinicalTrials.gov ID
- NCT05619042
- Acronym / sponsor ID
- CAC-TRAIT / CCT2
- Keywords
- risk stratification, Cardiovascular disease (CVD) screening, general population, transcriptomics, primary prevention, artificial intelligence, no history of CVD, subclinical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Santiago Gabriel MiriukaUniversity, hospital or other
- Collaborators
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Presence / absence of CAC | – | –Participants with or without a level/extension of CAC |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coronary artery calcium score
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.
19 secondary outcomes
Coronary artery calcium score
Time frame: At baseline (cross-sectional assessment)
Coronary artery calcium score (number of segments)
Time frame: At baseline (cross-sectional assessment)
Aortic valve calcium
Time frame: At baseline (cross-sectional assessment)
Thoracic aorta calcium
Time frame: At baseline (cross-sectional assessment)
Epicardial adipose tissue (volume)
Time frame: At baseline (cross-sectional assessment)
Epicardial adipose tissue (density)
Time frame: At baseline (cross-sectional assessment)
Fatty liver
Time frame: At baseline (cross-sectional assessment)
Neutrophil to lymphocyte ratio
Time frame: At baseline (cross-sectional assessment)
High-sensitive C reactive protein (CRP)
Time frame: At baseline (cross-sectional assessment)
Repolarization abnormalities
Time frame: At baseline (cross-sectional assessment)
Left ventricular hypertrophy
Time frame: At baseline (cross-sectional assessment)
Intraventricular conduction abnormalities
Time frame: At baseline (cross-sectional assessment)
Percent electron density relative to water (%EDW)
Time frame: At baseline (cross-sectional assessment)
Death
Time frame: year 1 through 5
Acute ischemic syndrome
Time frame: year 1 through 5
Heart failure
Time frame: year 1 through 5
Vascular revascularization
Time frame: year 1 through 5
cerebrovascular event
Time frame: year 1 through 5
Cancer
Time frame: year 1 through 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago G Miriuka, MD MSc PhD principal investigator
MultiplAI Health LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Atheroscleroses, Coronary, run by Santiago Gabriel Miriuka at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery calcium score (time frame: At baseline (cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.