Thrombosis and Inflammation in Vessels Initiative (TIVI)

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 100
Healthy Volunteers: t
View:

‣ 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

‣ 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

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Sandra Cooper Bennett, R.N.
sandra.cooper@nih.gov
(240) 328-0465
Backup
Yogendra Kanthi, M.D.
yogen.kanthi@nih.gov
(301) 529-7297
Time Frame
Start Date: 2024-11-22
Estimated Completion Date: 2034-01-30
Participants
Target number of participants: 1000
Treatments
Affected Participants and Relatives
Participants with relevant immune, inflammation, thrombotic and/or vascular diseases and their relatives
Healthy Volunteers
Healthy volunteers
Related Therapeutic Areas
Sponsors
Leads: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov