Comparing plasma proteins and metabolites in coronary artery disease patients

Cross-sectional Cohort Analysis of Plasma Proteomics in Coronary Artery Disease and Plasma Metabolomics in Coronary Artery Disease: Comparative Study Between Patients with Obstructive (≥ 50%), Non-obstructive (< 50%) and No Lesions

This study is trying to find new blood markers in people with different types of coronary artery disease to see if they can help predict heart problems and lead to better treatments.

Quick facts

• Study type: Observational
• Enrollment: 66 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: University of Sao Paulo General Hospital (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06900270 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate and compare the plasma proteomic and metabolomic profiles of three groups of patients: those without atherosclerotic lesions, those with non-obstructive lesions (less than 50%), and those with obstructive lesions (50% or more). By utilizing coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA), the study seeks to identify potential prognostic biomarkers associated with coronary artery disease (CAD) and their relationship with clinical events. The research focuses on discovering novel biological indicators that could lead to personalized therapies for patients, particularly those with non-obstructive lesions who are at risk for coronary events.

Who should consider this trial

Good fit: Ideal candidates for this study include patients with no history of atherosclerotic disease, those with non-obstructive coronary lesions, and those with obstructive coronary lesions.

Not a fit: Patients with non-atherosclerotic heart diseases, severe nephropathy, or those with acute coronary syndromes within the last 90 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the identification of new biomarkers that enable earlier detection and personalized treatment strategies for patients with coronary artery disease.

How similar studies have performed: While the approach of using plasma proteomics and metabolomics is promising, it is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

1. Group I: Patients without manifest atherosclerotic disease (no history of angina, previous myocardial infarction, prior revascularization, cerebrovascular disease, or peripheral vascular disease).
2. Group II: Patients with non-obstructive coronary lesions (\< 50%) detected on coronary computed tomography angiography (CCTA) or invasive coronary angiography (ICA).
3. Group III: Patients with obstructive coronary lesions (≥ 50%) detected on CCTA or ICA.

Exclusion Criteria:

1. Patients who refuse to sign the informed consent form (ICF);
2. Individuals with non-atherosclerotic heart disease (such as valvular diseases, cardiomyopathies, or congenital heart diseases);
3. Severe nephropathy (creatinine clearance \< 30 mL/min/1.73 m² body surface area);
4. Malignant neoplasms or other chronic diseases with poor prognosis;
5. Patients with acute coronary syndromes within the last 90 days;
6. Active smoking.

Where this trial is running

São Paulo, São Paulo

• Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Protasio da Luz PhD — Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo
• Study coordinator: Vinícius Quintão MD

Conditions Coronary Arterial Disease; Atherosclerosis; Coronary Circulation; Coronary Artery Disease; Coronary Occlusion; Proteomics; Metabolomics