Lipid Screening Study

NCT07579325 | Completed

• 1 other identifier: STUDY0009025
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to estimate the prevalence of elevated Lipoprotein (a) in an adult primary care population and to describe the distribution of atherogenic lipid markers within this cohort. This pilot study will provide preliminary data to inform future cardiovascular risk assessment initiatives in primary care.

Conditions

Lipoprotein (a)

Keywords

lipoprotein (a); HDL and LDL; HDL; LDL; lipid Panel

Outcome Measures

Primary Outcomes (1)

• Lipoprotein(a) prevalence in Adults

  The purpose of this pilot study is to estimate the prevalence of elevated Lipoprotein (a) in an adult primary care population and to describe the distribution of atherogenic lipid markers within this cohort. This pilot study will provide preliminary data to inform future cardiovascular risk assessment initiatives in primary care.

  3 months

Interventions

Venipuncture OTHER

The study procedures include a single venipuncture (10 mL) performed for research purposes to obtain blood samples for laboratory analysis of lipoprotein(a), apolipoprotein B, and a lipid panel with reflex to direct Low-Density Lipoprotein (LDL) cholesterol measurement. The lipid panel includes total cholesterol, triglycerides, High-Density Lipoprotein (HDL) cholesterol, and calculated non-HDL cholesterol and cholesterol/HDL ratio. If triglyceride levels exceed the laboratory threshold for accurate calculation of LDL cholesterol, a direct LDL cholesterol assay will be performed per standard laboratory protocol. In addition, the study includes abstraction of demographic and clinical information from the electronic medical record (EMR), including age, sex, BMI, comorbid conditions, and cardiovascular history. All laboratory analyses will be performed using standard clinical laboratory assays. No investigational drugs or medical devices are being used in this study.

Eligibility Criteria

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

Study Population

As any adult patient can be enrolled, no pre-screening will be done. UCFH only sees adult patients.

You may qualify if:

• Adults aged 18 years or older
• Receiving care at UCF Health primary care clinic
• Able to understand and provide informed consent and HIPAA authorization

You may not qualify if:

• Patient self discloses any medical condition that would make venipuncture unsafe
• Pregnant women

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, 32827, United States

Location

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stephanie Perez, MSN, MBA, ARNP, CLS, BHCN

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: May 5, 2026
• Primary Completion: July 16, 2026
• Study Completion: July 28, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

US (1)