Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552767
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Thrombosis and Inflammation in Vessels Initiative TIVI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Thrombosis and Inflammation in Vessels Initiative TIVI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 75 years
Some visits may be done by telehealth
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 75 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None