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Protocol Details

Thrombosis and Inflammation in Vessels Initiative (TIVI)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001781-H

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 5 Years
Max Age: 100 Years

Referral Letter Required

No

Population Exclusion(s)

Neonates;
Fetuses

Keywords

Vascular

Recruitment Keyword(s)

None

Condition(s)

Cardiovascular Diseases;
Vascular Diseases

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood Institute

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.

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Eligibility

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) 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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Yogendra Kanthi, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CRC BG RM 5-5130
10 CENTER DR
BETHESDA MD 20892
(301) 529-7297
yogen.kanthi@nih.gov

Sharon Osgood, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 3-2473
10 Center Drive
Bethesda, Maryland 20892
(301) 827-3237
sharon.osgood@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT06552767

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