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| Name | Class |
|---|---|
| Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Hepatic steatosis |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rosana Poggio, MD MSc PhD | MultiplAI Health LTD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorio Julio Mendez | Ciudad Autónoma de Buenos Aire | Buenos Aires F.D. | 1405 | Argentina | ||
| Clinica Sagrada Familia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2023 | Oct 31, 2023 |
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Whole-blood samples will be collected and analysed, and oral swab samples containing DNA will be stored for later analysis
Defined as liver attenuation level lower than 48 Hounsfield units (HU), and lower than than the spleen attenuation. |
| At baseline (cross-sectional assessment) |
| Coronary artery inflammation (perivascular fat attenuation index) | This secondary analysis will be performed using using specific software. | At baseline (cross-sectional assessment) |
| Death | Death | Up to 5 years of Follow-up |
| Ciudad Autónoma de Buenos Aire |
| Buenos Aires F.D. |
| 1425 |
| Argentina |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2023 | Oct 31, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D058226 | Plaque, Atherosclerotic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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