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Thrombosis and Inflammation in Vessels Initiative (TIVI)

National Heart, Lung, and Blood Institute (NHLBI) · NCT06552767

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 5–100 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
1000
US sites recruiting
1
Study start
November 22, 2024
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • 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

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: Yogendra Kanthi, M.D. · 301-529-7297 · yogen.kanthi@nih.gov

Study contacts (from the official record)

  • Jessenia C Campos, R.N. · (301) 402-0300 · jessenia.campos@nih.gov
  • Yogendra Kanthi, M.D. · (301) 529-7297 · yogen.kanthi@nih.gov
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Thrombosis and Inflammation in Vessels Initiative (TIVI) (NCT06552767) | Bored Studies