Thrombosis and Inflammation in Vessels Initiative (TIVI)

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.

• 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