Platelets and Plasma Lipids Relationship as a Biomarker and Potential Therapeutic Target of Thrombogenesis

NCT07774845 | Recruiting

• 3 other identifiers: SDC: 6137/25/1482023/10447-42025/29035-3
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to compare the effect of two different lipid emulsion formulations versus no emulsion on platelet aggregation in individuals without a history of ischemic disease. The hypothesis of this study is: Platelet aggregation is inversely associated with higher plasma lipid concentrations. The researchers will compare platelet aggregation in the presence and absence of lipid nanoemulsions in vitro through three pathways using the agonists collagen, adenosine diphosphate, and arachidonic acid. The tests will be performed using light-transmission aggregometry. Various participant parameters, such as lipid profile, will be evaluated to analyze possible correlations with the observed results. Participants must: Meet the study's inclusion criteria; Sign the informed consent form; Report to the blood draw laboratory at InCor's AB on the scheduled date and time after fasting for at least 8 hours.

Conditions

Cardio Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Effect of Lipid Emulsions on Platelet Aggregation Assessed by Optical Aggregometry

  Comparison of the effect of different lipid emulsion formulations versus no emulsion (control) on platelet aggregation in blood samples from individuals without a history of ischemic disease.

  Day 1 (single blood sample collection)

Study Arms (2)

Control group

The same group of study participants. Platelet aggregation tests without the addition of lipid nanoemulsions.

Case group

Study participants. Platelet aggregation tests with the addition of lipid nanoemulsions.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible individuals satisfying the standard wellness criteria.

You may qualify if:

• Men and women aged ≥ 40 years.
• Willingness to sign the informed consent form.
• Absence of known atherosclerotic disease

You may not qualify if:

• Use of antiplatelet agents.
• Use of anticoagulants.
• Use of lipid-lowering agents.
• Use of oral hypoglycemic agents or insulin.
• Known atherosclerotic disease.
• Refusal to sign the informed consent form

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Heart Institute, University of São Paulo Medical School (InCor/HCFMUSP)

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Central Study Contacts

José C Nicolau, Senior Professor

CONTACT

11971514117; jose.nicolau@fm.hc.usp.br

Juliana L L F Regueira, Postdoctoral Res. Associate

CONTACT

11959564983; julianaliraregueira@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Professor

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 19, 2026
• Study Start: March 5, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 19, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

BR (1)