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RecruitingNCT05403151Updated Sep 4, 2026

Controls and Healthy Vasculature Initiative

An observational study in Vascular And Immunologic Diseases and Healthy Volunteers, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Background:

Diseases involving blood, blood vessels, and immune systems are leading causes of death in the United States. Researchers studying these diseases need to compare blood samples from both healthy and sick individuals. Blood samples from healthy people are also used to establish what is normal when developing new tests for diseases and to make sure new testing equipment is working properly.

Objective:

This natural history study will collect blood samples from healthy people. The blood will be used for various kinds of research.

Eligibility:

Healthy adults aged 18 years or older. Pregnant or nursing women will be excluded.

Design:

Participants will have a telehealth visit or telephone call to review their medical history.

They will come to the NIH Clinical Center. They will have a needle inserted into a vein in their arm or hand. About 10 tablespoons of blood will be drawn through the needle.

Researchers may perform a complete blood count, a type of blood test that can help evaluate the participant s overall health. They may do a blood type test.

The blood samples will also be used for genetic studies.

Some blood samples may be stored for use in future research.

Participants may choose to return for repeat visits for up to 10 years. Review of their medical history may also be repeated at later visits. They will receive $50 per blood collection visit.

...

Read the detailed description

Study Description:

This study will serve to provide tissue samples from individuals with healthy vasculature for mechanistic studies of vascular inflammation and thrombosis.

Objectives:

Primary Objective:

To collect samples from healthy volunteers to:

  • Establish and validate technical assays and equipment (e.g. platelet aggregation, inflammasome activation, neutrophil extracellular trap formation, tissue factor activity, etc.)
  • Establish normal physiologic mechanisms and parameters in samples from healthy volunteers (e.g. platelet function, circulating autoantibody titers, etc.)

Endpoints:

This protocol does not have an outcome measure, but rather will be conducted in accordance with Good Clinical Practices for human research solely for the purpose of obtaining blood samples to optimize assays, conduct mechanistic investigations, measure vascular biomarkers, and facilitate the study of vascular and immunologic diseases in patients enrolled in other studies.

02

Conditions studied

  • Vascular And Immunologic Diseases
  • Healthy Volunteers

Keywords

  • Sample Collection
  • Vascular
  • Blood
  • Inflammation
  • Thrombosis
  • Natural History
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy Volunteers

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Stated willingness to comply with all study procedures
  • Aged 18 years and older
  • Ability of subject to understand and the willingness to sign a written informed consent document
  • Self-reported in good general health

Exclusion criteria

EXCLUSION CRITERIA:

An individual who, by self-report, meets the following criteria will be excluded from participation in this study:

-Current pregnancy or lactation

04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • 1

    Healthy Adults

05

What researchers measure

Primary outcomes

  1. To collect samples from healthy volunteers to establish and validate technical assays and normal physiologic mechanisms and parameters for on-going and future basic and translational research studies.

    This protocol does not have an outcome measure, but will obtain blood samples to optimize assays, conduct mechanistic investigations, measure vascular biomarkers, and facilitate the study of vascular and immunologic diseases in patients enrolled in other studies.

    Time frame: Up to 10 Years

06

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05403151
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Jun 3, 2022
Start date
Jul 1, 2022
Primary completion
Jan 30, 2032 (estimated)
Completion
Jan 30, 2032 (estimated)
Last update
Sep 4, 2026

Study contacts

Jessenia C Campos, R.N.
Contact
jessenia.campos@nih.gov
(301) 402-0300
Yogendra Kanthi, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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