Recruiting

Observational Study

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT06552767

Conditions

Cardiovascular Diseases

Vascular Diseases

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Background:

Diseases related to the immune system, blood clots, and blood vessels can affect every part of the body. These diseases are now known to be interrelated: People who have strokes, blood clots in their legs, or autoimmune disease, for example, are at greater risk of complications in the heart, brain, and other organs. Researchers want to learn more about how these diseases start, how they change over time, and how they affect different organs.

Objective:

To learn more about how inflammation and diseases of the blood vessels start and how they change over time.

Eligibility:

People aged 5 years and older with a disease related to blood clots, the immune system, or blood vessels. Healthy relatives of people with these diseases and unrelated healthy volunteers are also needed.

Design:

Participants will have a baseline visit: They will provide a medical history, physical exam and blood test. All other tests and procedures are optional; these may be spread over more than 1 day:

Tests of heart and lung function.

Fill in a family tree form.

Imaging scans

Treadmill or bike stress tests and a 6-minute walk test.

Tests of blood pressure and the flow of blood through vessels.

Photos of the face and body.

Eye exams, with photos taken of the retina.

Saliva and urine samples.

Biopsies (tissues samples) of the skin and fat.

Tests of thinking and mental function.

Evaluations by other medical specialists.

Participants may opt to return for repeat testing for up to 90 months (7.5 years).

Some visits may be done by telehealth.

Conditions

Cardiovascular Diseases

Vascular Diseases

Study ID

NCT06552767

Start date

Nov 22, 2024

Status verified date

Sep 3, 2026

Completion date

Jan 30, 2034

Anticipated

Primary completion date

Jan 30, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

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

  • Age >= 5 years at the time of consent
  • Ability of subject or Legally Authorized Representative (LAR) as applicable to understand and the willingness to sign a written informed consent document

In addition, the following cohort-specific inclusion criteria apply:

Affected Subjects:

-Known or possible thrombotic, immune, or vascular disorder after review of the subject s medical records and/or discussion of medical history

Relatives of Affected Subjects:

-Being a relative of an affected subject

Unrelated Healthy Controls:

-In good general health as evidenced by medical history

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

-Any condition that in the opinion of the Investigator would warrant exclusion

Unrelated Healthy Controls:

  • Unrelated healthy volunteers who decline to have blood drawn and/or tissue studies or who do not consent to have samples stored for future research
  • Cognitively impaired individuals

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Affected Participants and Relatives

Participants with relevant immune, inflammation, thrombotic and/or vascular diseases and their relatives

Healthy Volunteers

Healthy volunteers

Primary outcome measure

  • This is a disease discovery protocol and there are no specific endpoints associated with this protocol. [ Time Frame: Study End ]

Central Contacts and Locations

Central contacts

Jessenia C Campos, R.N.

(301) 402-0300jessenia.campos@nih.gov

Yogendra Kanthi, M.D.

(301) 529-7297yogen.kanthi@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Yogendra Kanthi, M.D.

301-529-7297yogen.kanthi@nih.gov

Jessenia Campos, R.N.

(301) 402-0300jessenia.campos@nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Sep 10, 2026

Last verified

Sep 3, 2026

Keywords

  • Vascular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-09-10.