Controls and Healthy Vasculature Initiative

Sponsor

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT05403151

Collaborator

(none)

1,000

Enrollment

Location

115

Anticipated Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vascular And Immunologic Diseases Healthy Volunteers

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Controls and Healthy Vasculature Initiative

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jan 30, 2032

Anticipated Study Completion Date :

Jan 30, 2032

Arms and Interventions

Arm	Intervention/Treatment
1 Healthy Adults

Outcome Measures

Primary Outcome Measures

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. [Up to 10 Years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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