Cardio Vascular DiseaseNCT07774845
Platelets and Plasma Lipids Relationship as a Biomarker and Potential Therapeutic Target of Thrombogenesis
An observational study of Cardio Vascular Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardio Vascular Disease
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Mar 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible individuals satisfying the standard wellness criteria.
Who may be able to join
- Men and women aged ≥ 40 years.
- Willingness to sign the informed consent form.
- Absence of known atherosclerotic disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute, University of São Paulo Medical School (InCor/HCFMUSP)
São Paulo, São Paulo, 05403-900
Juliana L. L. F. Regueira, PhD
About this study
Official title: Development and Validation of a New Method to Valuate the Platelet-Plasma Lipid Relationship as a Biomarker and Potential Therapeutic Target of Thrombogenesis
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.
Read more
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.
Read the detailed description
A prospective case-control study in which the selected volunteers will serve as their own controls.
Participant Selection:
Volunteers with no known atherosclerotic disease will be selected from among employees of InCor/HCFMUSP and, if necessary, from the donor waiting list of the HCFMUSP blood bank.
- Conditions
- Cardio Vascular Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (single blood sample collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start5 Mar 2026
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos Nicolau, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774845
- Sponsor's protocol ID
- SDC: 6137/25/148
- Other IDs
- 2023/10447-4, 2025/29035-3, 2025, 2023
- Status last verified
- Oct 2025
- First submitted
- 5 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared only among the researchers directly involved in the project.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a New Method to Valuate the Platelet-Plasma Lipid Relationship as a Biomarker and Potential Therapeutic Target of Thrombogenesis
- ClinicalTrials.gov ID
- NCT07774845
- Acronym / sponsor ID
- SDC: 6137/25/148
- Conditions
- Cardio Vascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective case-control study in which the selected volunteers will serve as their own controls.
Participant Selection:
Volunteers with no known atherosclerotic disease will be selected from among employees of InCor/HCFMUSP and, if necessary, from the donor waiting list of the HCFMUSP blood bank.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible individuals satisfying the standard wellness criteria.
Key inclusion criteria (3 listed)
- Men and women aged ≥ 40 years.
- Willingness to sign the informed consent form.
- Absence of known atherosclerotic disease
Key exclusion criteria (6 listed)
- Use of antiplatelet agents.
- Use of anticoagulants.
- Use of lipid-lowering agents.
- Use of oral hypoglycemic agents or insulin.
- Known atherosclerotic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of Lipid Emulsions on Platelet Aggregation Assessed by Optical Aggregometry
Time frame: Day 1 (single blood sample collection)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be shared only among the researchers directly involved in the project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio Vascular Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José C Nicolau, Senior Professor (11971514117, jose.nicolau@fm.hc.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Lipid Emulsions on Platelet Aggregation Assessed by Optical Aggregometry (time frame: Day 1 (single blood sample collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.