Coronary Stenosis Clinical Trial
— CORPLAQ-TRAITOfficial title:
Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography: CORPLAQ-TRAIT Pilot Study
Verified date | January 2024 |
Source | MultiplAI Health Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 200 |
Est. completion date | September 2028 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Clinica Sagrada Familia | Ciudad Autónoma de Buenos Aire | Ciudad Autónoma De Buenos Aires |
Argentina | Sanatorio Julio Mendez | Ciudad Autónoma de Buenos Aire | Ciudad Autónoma De Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
MultiplAI Health Limited | Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Presence and extent of aortic calcification | Aortic valve calcification score (Agatston units) as a continuous variable with increasing risk and without preestablished thresholds (ranging from 0 to 5.000 Agatston units). | At baseline (cross-sectional assessment) | |
Secondary | Hepatic steatosis | Defined as liver attenuation level lower than 48 Hounsfield units (HU), and lower than than the spleen attenuation. | At baseline (cross-sectional assessment) | |
Secondary | Coronary artery inflammation (perivascular fat attenuation index) | This secondary analysis will be performed using using specific software. | At baseline (cross-sectional assessment) | |
Secondary | Death | Death | Up to 5 years of Follow-up |
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