Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography

NCT06194526 | Enrolling By Invitation

• 1 other identifier: ACTC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (4)

• Coronary 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)

• Total coronary plaque burden

  The extension of atherosclerotic disease burden will be assessed using the Modified Duke prognostic CAD index as follows: 1) ,50% stenosis; (2) ≥2 non-obstructive stenoses (including one artery with proximal disease or one artery with 50-69% stenosis); (3) two vessels with stenoses 50-69% or one vessel with ≥70% stenosis; (4) three-vessel disease with stenoses 50-69%, or two vessels ≥70%, or proximal LAD stenosis ≥70%; (5) three-vessel disease with stenoses ≥70% or two-vessel disease ≥70% with proximal LAD; (6) left main stenosis ≥50%.

  At baseline (cross-sectional assesment)

• Degree of coronary stenosis

  Each coronary segment will be graded based on the degree of coronary stenosis as 0% (no visible stenosis), 1-24% (minimal stenosis); 25-49% (mild stenosis); 50-69% (moderate stenosis); 70-99% (severe stenosis); 100% (occluded).

  At baseline (cross-sectional assesment)

• Coronary high-risk plaques (low-attenuation, positive remodeling; spotty calcification, or napkin-ring sign)

  Presence of any of the following features: low-attenuation (average density equal or lower than 30 Hounsfield units), positive remodeling (remodeling index equal or higher than 1.1; spotty calcification (average density \>130 HU, diameter \<3 mm in any direction with the length of the calcium \<1.5 times the vessel diameter and width of the calcification less than two-thirds of the vessel diameter), or napkin-ring sign (ring-like attenuation pattern with peripheral high attenuation tissue that surrounds a central lower attenuation portion).

  At baseline (cross-sectional assesment)

Secondary Outcomes (4)

• Presence and extent of aortic calcification

  At baseline (cross-sectional assessment)

• Hepatic steatosis

  At baseline (cross-sectional assessment)

• Coronary artery inflammation (perivascular fat attenuation index)

  At baseline (cross-sectional assessment)

• Death

  Up to 5 years of Follow-up

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MultiplAI Health Limited: lead
• Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia: collaborator

Study Sites (2)

Sanatorio Julio Mendez

Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., 1405, Argentina

Location

Clinica Sagrada Familia

Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., 1425, Argentina

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole-blood samples will be collected and analysed, and oral swab samples containing DNA will be stored for later analysis

MeSH Terms

Conditions

Coronary Stenosis; Plaque, Atherosclerotic; Inflammation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Rosana Poggio, MD MSc PhD

  MultiplAI Health LTD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: January 8, 2024
• Study Start: September 19, 2023
• Primary Completion: August 1, 2024
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

AR (2)