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

NCT06900270 | Recruiting

• 1 other identifier: ProteoDAC and MetaDAC study
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Arterial Disease (CAD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Identification of Differentially Expressed Proteins in Coronary Artery Disease Groups

  Identification of Differentially Expressed Proteins Among Three Groups (No Lesion, Non-Obstructive Lesion, and Obstructive Lesion)

  1 Year

Secondary Outcomes (3)

• Proteomic Biomarkers and Classic Risk Factors Correlation

  1 Year

• Association of Identified Proteins with Clinical Events in CAD

  1 Year

• Differential Protein Expression in Relation to Laboratory Biochemical Parameters

  1 Year

Study Arms (3)

Group I

No atherosclerotic lesions

Group II

Non-obstructive coronary lesions (\< 50%)

Group III

Obstructive coronary lesions (≥ 50%)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (16)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood Plasma Sample for Proteomic and Metabolomic Analysis

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Coronary Occlusion

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• Protasio da Luz PhD

  Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinícius Quintão MD

CONTACT

55 11 2661-5795; vinicius.quintao@hc.fm.usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 28, 2025
• Study Start: August 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)