Understanding blood vessel diseases and inflammation
Thrombosis and Inflammation in Vessels Initiative (TIVI)
This study is trying to understand how blood vessel diseases and inflammation are connected by looking at people with these conditions, their healthy family members, and other healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 5 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06552767 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the interrelation between thrombotic, immune, and vascular diseases, focusing on how these conditions develop and evolve over time. Participants, including those affected by these diseases, their healthy relatives, and unrelated healthy volunteers, will undergo a baseline visit involving medical history, physical exams, and optional blood tests. The study seeks to collect data and biospecimens to inform future clinical investigations and improve understanding of vascular health. By examining clinical, radiographic, immunological, and genetic characteristics, researchers hope to develop better diagnostic and management strategies.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 5 years and older with thrombotic, immune, or vascular disorders, as well as their healthy relatives and unrelated healthy volunteers.
Not a fit: Patients with conditions that would warrant exclusion as determined by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular and vascular diseases, potentially reducing morbidity and mortality.
How similar studies have performed: While this study builds on existing knowledge of vascular diseases, it employs a novel approach to collect comprehensive data and biospecimens for future research.
Eligibility criteria
Show full inclusion / exclusion 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) 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Yogendra Kanthi, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Sandra Cooper Bennett, R.N.
- Email: sandra.cooper@nih.gov
- Phone: (240) 328-0465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.