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RecruitingNCT06552767Updated Oct 6, 2026

Thrombosis and Inflammation in Vessels Initiative (TIVI)

An observational study in Cardiovascular Diseases and Vascular Diseases, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Recruiting at 1 site in United States. Open to participants aged 5 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,000
Ages
5 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

Study Description:

Thrombotic vascular disorders remain the leading cause of morbidity and mortality in the United States. The proximate determinants of thrombosis, arterial, venous, and lymphatic vascular disorders and their treatments remains incompletely understood. In pursuit of improved vascular health, this disease discovery protocol will facilitate rapid initiation of new clinical and molecular phenotype-specific investigations to collect data and biospecimens on affected individuals, family members, and unrelated healthy controls. The data collected in this protocol will inform the design of future disease-specific investigational protocols.

Objectives:

Primary Objective:

To study the pathogenesis of patients affected with thrombotic, immune, vascular, and cardiovascular conditions including clinical, radiographic, immunological and genetic characteristics of the disease.

Secondary Objectives:

  • To develop long-term clinical and laboratory outcome parameters of organ involvement in patients with thrombotic, inflammatory, vascular and cardiovascular diseases
  • Evaluation of blood, body fluid, and tissue biomarkers during disease flares and quiescence.
  • To develop disease activity indices for vascular disease that incorporate clinical, laboratory, and imaging data.
  • Screening for other NHLBI clinical studies
  • To evaluate patients referred for suspected vascular disease and provide additional opinions for diagnosis and management recommendations

Endpoints:

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

02

Conditions studied

  • Cardiovascular Diseases
  • Vascular Diseases

Keywords

  • Vascular
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • Affected Participants and Relatives

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

  • Healthy Volunteers

    Healthy volunteers

06

What researchers measure

Primary outcomes

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

    Time frame: Study End

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Deidentified data from IPD or aggregated data may be shared in publications for scientific data reporting and interpretation.

Supporting information: Study protocol, Icf

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06552767
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Aug 14, 2024
Start date
Nov 22, 2024
Primary completion
Jan 30, 2034 (estimated)
Completion
Jan 30, 2034 (estimated)
Last update
Oct 6, 2026

Study contacts

Jessenia C Campos, R.N.
Contact
jessenia.campos@nih.gov
(301) 402-0300
Yogendra Kanthi, M.D.
Contact
yogen.kanthi@nih.gov
(301) 529-7297
Yogendra Kanthi, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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