Thrombosis and Inflammation in Vessels Initiative (TIVI)

NCT06552767 | Recruiting

• 2 other identifiers: 10001781001781-H
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

Vascular

Outcome Measures

Primary Outcomes (1)

• This is a disease discovery protocol and there are no specific endpoints associated with this protocol.

  Study End

Study Arms (2)

Affected Participants and Relatives

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

Healthy Volunteers

Healthy volunteers

Eligibility Criteria

• Age: 5 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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) to understand and the willingness to sign a written informed consent document
• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yogendra Kanthi, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Cooper Bennett, R.N.

CONTACT

(240) 328-0465; sandra.cooper@nih.gov

Yogendra Kanthi, M.D.

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 14, 2024
• Study Start: November 22, 2024
• Primary Completion (Estimated): January 30, 2034
• Study Completion (Estimated): January 30, 2034
• Last Updated: January 23, 2026

Record last verified: 2026-01-21

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Where appropriate, deidentified IPD will be made accessible as noted in the data management plan filed for this study.
• Access Criteria: Where appropriate, deidentified IPD will be made accessible as noted in the data management plan filed for this study.

Locations

US (1)