Cardiovascular DiseasesNCT06552767
Thrombosis and Inflammation in Vessels Initiative (TIVI)
An observational study of Cardiovascular Diseases and Vascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Vascular Diseases
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2024to 30 Jan 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with relevant immune, inflammation, thrombotic and/or vascular diseases and their relatives Healthy volunteers
Who may be able to join
- 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
Show all 10Show fewer
- Relatives of Affected Subjects:
- -Being a relative of an affected subject
- Unrelated Healthy Controls:
- -In good general health as evidenced by medical history
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Yogendra Kanthi, M.D., 301-529-7297, yogen.kanthi@nih.gov
Jessenia Campos, R.N., (301) 402-0300, jessenia.campos@nih.gov
About this study
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.
Read more
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.
- Conditions
- Cardiovascular Diseases, Vascular Diseases
- Keywords
- Vascular
- Medical subject headings
- Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected Participants and Relatives | Participants with relevant immune, inflammation, thrombotic and/or vascular diseases and their relatives | |
| Healthy Volunteers | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
This is a disease discovery protocol and there are no specific endpoints associated with this protocol.
Measured: Study End
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start22 Nov 2024
- Primary completion30 Jan 2034 (estimated)
- Study completion30 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Yogendra Kanthi, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552767
- Sponsor's protocol ID
- 10001781
- Other IDs
- 001781-H
- Status last verified
- 2 Oct 2026
- First submitted
- 7 Aug 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data from IPD or aggregated data may be shared in publications for scientific data reporting and interpretation.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombosis and Inflammation in Vessels Initiative (TIVI)
- ClinicalTrials.gov ID
- NCT06552767
- Acronym / sponsor ID
- 10001781
- Conditions
- Cardiovascular Diseases, Vascular Diseases
- Keywords
- Vascular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 30 Jan 2034 (estimated)
- Study completion
- 30 Jan 2034 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected Participants and Relatives | – | –Participants with relevant immune, inflammation, thrombotic and/or vascular diseases and their relatives |
| Healthy Volunteers | – | –Healthy volunteers |
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with relevant immune, inflammation, thrombotic and/or vascular diseases and their relatives Healthy volunteers
Key inclusion criteria (10 listed)
- 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
- -Known or possible thrombotic, immune, or vascular disorder after review of the subject s medical records and/or discussion of medical history
- -Being a relative of an affected subject
Key exclusion criteria (5 listed)
- 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
This is a disease discovery protocol and there are no specific endpoints associated with this protocol.
Time frame: Study End
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified data from IPD or aggregated data may be shared in publications for scientific data reporting and interpretation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yogendra Kanthi, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Vascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessenia C Campos, R.N. ((301) 402-0300, jessenia.campos@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This is a disease discovery protocol and there are no specific endpoints associated with this protocol. (time frame: Study End). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.