Comparative of Plasma Proteomics & Metabolomics in Coronary Artery Disease: Obstructive,Non-Obstructive, & No Lesions

Recruiting now

Conditions studied: Coronary Arterial Disease (CAD)

In brief

The presence and clinical evolution of coronary atherosclerosis depend on various classic risk factors and biomarkers. However, the search for more specific markers is necessary, especially for individuals with non-obstructive coronary artery disease, lesions \< 50%. In this regard, the field of plasma proteomics could enable the discovery of these novel biological indicators. To evaluate and compare the differences in the proteomic profile among three groups of individuals, namely those without atherosclerotic lesions, those with non-obstructive lesions in coronary flow (\< 50%), and those with obstructive lesions (e 50%), as determined by findings from coronary computed tomography angiography (CCTA) or invasive coronary angiography (ICA). The aim is to assess their relationship with typical clinical events of coronary artery disease (CAD) and detect potential prognostic biomarkers associated with each group. A cross-sectional cohort study involving 66 patients selected and recruited based on CCTA and ICA results obtained at the Heart Institute of the Hospital das Clínicas of the School of Medicine, University of São Paulo (InCor, HC-FMUSP). The patients were divided into the aforementioned three groups, with 22 individuals in each group, and underwent blood collection for biochemical and proteomic analysis, as well as clinical and demographic characterization. The likely differentiation of the proteomic and metabolomic profile among the groups and identification of biological markers for CAD would contribute to the understanding of its pathophysiology and enable a change in clinical decision-making, particularly regarding disease progression prevention and clinical events.

Key facts

Study ID: NCT06900270
Run by: University of Sao Paulo General Hospital
People needed: 66
Starts: 2024-08-01
Expected to finish: 2026-02-01
Last updated by the study team: 2025-03-28

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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