Lipoprotein Interactions and Platelet Function in Healthy Individuals and Those With Lipid Disorders

NCT06747000 | Recruiting DMC

• 2 other identifiers: 2195890710-7149062
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This study looks at how lipoproteins, which are particles in the blood that transport cholesterol, influence heart and blood vessel health. Beyond just their levels, the way these particles function plays a key role in preventing or contributing to disease. In some conditions, like high cholesterol or diabetes, lipoproteins may not work properly, increasing the risk of clogged arteries and other complications. The investigators aim to study these changes in people with lipid disorders to better understand their impact on blood health and to find new ways to prevent and treat heart disease.

Conditions

Lipid Disorders

Keywords

lipids; lipoproteins; platelets; high cholesterol

Outcome Measures

Primary Outcomes (1)

• Percentage of platelet aggregation

  Platelet aggregation area under the curve will be used as primary endpoint. Specifically, the percentage of platelet aggregation multiple time will be calculated to get area under the curve as a comprehensive marker for platelet aggregation response.

  5 years

Secondary Outcomes (7)

• Percentage of Activated Platelets as Assessed by Flow Cytometry

  5 years

• Plasma levels of CRP in mg/L

  5 years

• Plasma levels of resolvins in pg/mL

  5 years

• Plasma Levels of IL-6 in pg/mL

  5 years

• Plasma Levels of TNF-α in pg/mL

  5 years

Study Arms (2)

Individuals with lipid disorders

Individuals with lipid disorders (elevated HDL and LDL)

Healthy individuals

Healthy individuals with normal lipid values and without lipid-related diseases

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We Planning to start recruiting process in July 2024. We will identify potential subjects who are seen in the lipid clinic of Lifespan hospitals by EMR review. We will contact potential subjects at a routine care lipid clinic visit or by phone independent of their routine care visits. Recruitment will take place at the Lipid Clinic at Lifespan Hospital, the Brown campus, and our research lab.

You may qualify if:

• Healthy volunteers
• Abnormalities in lipid panels
• Able to provide informed consent
• Between the age of 18 and 69

You may not qualify if:

• Drug or alcohol abuse within 6 months or significant mental/psychological impairment
• Current smokers
• Subjects with known bleeding disorders (for example, hemophilia)
• Subjects requiring regular transfusions for any reason
• No ethnic/racial groups will be excluded

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (2)

Brown University Health Lipid Clinic

East Providence, Rhode Island, 02914, United States

RECRUITING

Cardiovascular Research Center

Providence, Rhode Island, 02903, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Lipid Metabolism Disorders; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Dyslipidemias

Central Study Contacts

Wenliang Song, MD

CONTACT

4014449851; WSong@brownhealth.org

Daria Salamevich

CONTACT

7343588165; DSalamevich@brownhealth.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: July 18, 2024
• Primary Completion (Estimated): July 18, 2028
• Study Completion (Estimated): July 18, 2029
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (2)