Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography: CORPLAQ-TRAIT Pilot Study
Trial ID: NCT06194526
Status: ENROLLING_BY_INVITATION
Study type: OBSERVATIONAL
Start date: 2023-09-19
Completion date: 2028-09
Sponsor: MultiplAI Health Limited
Collaborators: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
Conditions: Calcific Coronary Arteriosclerosis; Coronary Stenosis; Coronary Plaque; Aortic Calcification; Atherosclerotic Plaque
Locations: Sanatorio Julio Mendez; Clinica Sagrada Familia
Countries: Argentina; Argentina
Enrollment: 200
Age range: 18 Years - 75 Years
Sex: ALL

Summary:
The present clinical study aims to identify transcriptomic patterns derived from whole blood samples related to coronary atherotic burden. Additionally, as a secondary analysis, the research team will explore the algorithm's ability to detect the presence of aortic disease and pro-inflammatory cardiometabolic alterations, such as hepatic steatosis and surrogate markers of coronary inflammation.

Eligibility criteria:
Inclusion Criteria:

* Men and women between 18 and 75 years, with a clinical indication to be evaluated by a CCTA due to suspected or known CAD.
* Signature of informed consent.

Exclusion Criteria:

* Previously known chronic renal or hepatic insufficiency.
* Active chronic lung disease, defined as: exacerbated asthma, exacerbated COPD, or pulmonary fibrosis.
* Myocardial infarction, unstable angina, cerebrovascular accident, or vascular interventions (any territory) in the past 6 months.
* Implantation of drug-eluting stents in the last 12 months.
* Revascularization surgery (By-pass)
* Indication of Angio-CT for congenital heart disease or Transcatheter Aortic Valve Replacement (TAVI)
* Presence/ diagnosis of heart failure symptoms or signs (ie. dyspnea, asthenia, edema) with objective evidence of pulmonary or systemic congestion at rest or with exercise in the last 6 months.
* Left ventricular ejection fraction \<50% confirmed by objective diagnostic methods (eg doppler echocardiogram).
* Severe valvulopathies, confirmed by objective diagnostic methods (eg doppler echocardiogram).
* 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 cure.
* Diagnosis of active autoimmune disease or any pathology under immunosuppressive treatment.
* Ongoing pregnancy, postpartum period of less than 12 months or breastfeeding.
* Other serious diseases with an estimated life expectancy of less than 12 months (according to the investigator's opinion).
* 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.
* Pacemaker/Cardio-Defibrillator Implantation.
* Prior to the study: heart rate \> 70 l/m or atrial fibrillation or frequent extrasystoles that in the opinion of the specialist physician will affect the quality of the cardiovascular imaging.

Outcomes:
Coronary calcium score; Total coronary plaque burden; Degree of coronary stenosis; Coronary high-risk plaques (low-attenuation, positive remodeling; spotty calcification, or napkin-ring sign)