Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms

NCT05619042 | Completed DMC

• 1 other identifier: CCT2
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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?

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (cross-sectional assessment)

Secondary Outcomes (19)

• Coronary artery calcium score

  At baseline (cross-sectional assessment)

• Coronary artery calcium score (number of segments)

  At baseline (cross-sectional assessment)

• Aortic valve calcium

  At baseline (cross-sectional assessment)

• Thoracic aorta calcium

  At baseline (cross-sectional assessment)

• Epicardial adipose tissue (volume)

  At baseline (cross-sectional assessment)

Study Arms (1)

Presence / absence of CAC

Participants with or without a level/extension of CAC

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santiago Gabriel Miriuka: lead
• Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia: collaborator

Study Sites (1)

Clinica Sagrada Familia

Buenos Aires, C1426EOB, Argentina

Location

Biospecimen

Retention: SAMPLES WITH DNA

Mouth swab samples, whole blood samples

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Plaque, Atherosclerotic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Santiago G Miriuka, MD MSc PhD

  MultiplAI Health LTD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Founder & CEO

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 16, 2022
• Study Start: November 7, 2022
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

AR (1)