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

NCT ID: NCT05619042

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2024-01-24

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.

Conditions

Atherosclerosis; Atheroscleroses, Coronary; Atherosclerotic Plaque

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Presence / absence of CAC

Participants with or without a level/extension of CAC

No interventions assigned to this group

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

OTHER

Sponsor Role: collaborator

Santiago Gabriel Miriuka

OTHER

Sponsor Role: lead

Responsible Party

Santiago Gabriel Miriuka

Co-Founder & CEO

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Santiago G Miriuka, MD MSc PhD

Role: PRINCIPAL_INVESTIGATOR

MultiplAI Health LTD

Locations

Clinica Sagrada Familia

Buenos Aires, , Argentina

Countries

Argentina

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CCT2

Identifier Type: -

Identifier Source: org_study_id