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NCT06900270Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 28 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
66 (estimated)
First submitted
18 Feb 2025
Start date
Aug 2024
Primary completion date
Jul 2025
Lead sponsor
University of Sao Paulo General Hospital
NCT number
NCT06900270

What you commit to

  • Study type: Observational
  • Planned participants: 66
  • From Aug 2024 to the primary completion date, Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Individuals with non-atherosclerotic heart disease (such as valvular diseases, cardiomyopathies, or congenital heart diseases);
  • Malignant neoplasms or other chronic diseases with poor prognosis;
  • Patients with acute coronary syndromes within the last 90 days;

Lab values

  • Severe nephropathy (creatinine clearance \< 30 mL/min/1.73 m² body surface area);

Other

  • Patients who refuse to sign the informed consent form (ICF);
  • Active smoking.

Who the study is looking for

  • 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.

Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.