Clinical trial NCT06194526: Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography
Official title: Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography: CORPLAQ-TRAIT Pilot Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Calcific Coronary Arteriosclerosis
Coronary Stenosis
Coronary Plaque
Aortic Calcification
Atherosclerotic Plaque
Keywords: risk stratification
CVD screening
general population
transcriptomics
primary prevention
artificial intelligence
no history of CVD & history of CVD
subclinical
inflammation
Lead sponsor: MultiplAI Health Limited
Sponsor class: OTHER
Collaborators: name: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
First posted: 2024-01-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 Men and Women between 18 and 75 years of age with a physician's indication of a CCTA evaluation due to suspected or known CAD.

Brief 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.

Detailed description: This will be a prospective observational study. A convenience sample will be carried out to include 200 patients who attend the ENERI Medical Institute, La Sagrada Familia Clinic and Sanatorio Mendez with a clinical indication to be evaluated by a CCTA due to suspected CAD or known CAD. 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 mucose will be taken. Subsequently, the images obtained from the clinically indicated CCTA will be assessed to explore the 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 follow-up will be carried out via telephone or email contact to collect data on the incidence of fatal and non-fatal cardiovascular events.

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.

Primary outcomes:
measure: Coronary calcium score
timeFrame: At baseline (cross-sectional assessment)
measure: Total coronary plaque burden
timeFrame: At baseline (cross-sectional assesment)
measure: Degree of coronary stenosis
timeFrame: At baseline (cross-sectional assesment)
measure: Coronary high-risk plaques (low-attenuation, positive remodeling; spotty calcification, or napkin-ring sign)
timeFrame: At baseline (cross-sectional assesment)
Secondary outcomes:
measure: Presence and extent of aortic calcification
timeFrame: At baseline (cross-sectional assessment)
measure: Hepatic steatosis
timeFrame: At baseline (cross-sectional assessment)
measure: Coronary artery inflammation (perivascular fat attenuation index)
timeFrame: At baseline (cross-sectional assessment)
measure: Death
timeFrame: Up to 5 years of Follow-up
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Sanatorio Julio Mendez
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Clinica Sagrada Familia
state: Ciudad Autónoma De Buenos Aires
Study officials:
affiliation: MultiplAI Health LTD
name: Rosana Poggio, MD MSc PhD
role: PRINCIPAL_INVESTIGATOR
References: