Non-Invasive Assessment of Atherosclerosis in Patients With CGD and Other Disorders of the Immune System
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|ClinicalTrials.gov Identifier: NCT01063309|
Recruitment Status : Recruiting
First Posted : February 5, 2010
Last Update Posted : March 29, 2018
- Atherosclerosis, the arterial plaques or blockages that cause heart disease, develops in many people by the time they are in their mid-20s. The rate of atherosclerosis in patients with immune system disorders has not been well studied, but it may be very different from the general population.
- Patients with chronic granulomatous disease (CGD) produce less of a group of molecules known as free radicals, which help to fight infection and may play a role in the development of atherosclerosis. Patients with CGD may develop atherosclerosis much more slowly than people without CGD. On the other hand, carrier mothers of children with genetically-linked CGD often have problems with autoimmune problems in addition to a problem with making free radicals. Patients with other immune system disorders also have very different responses to infection, and many of them also have autoimmune-like problems that may change the risk of developing atherosclerosis.
- To study the prevalence of atherosclerosis in patients with immune system disorders, compared with healthy individuals.
- Individuals at least 18 years of age who either have been diagnosed with an immune system disorder or are healthy volunteers.
- The active part of the study involves one or two visits to the National Institutes of Health Clinical Center for a series of imaging tests and scans.
- Participants will have the following tests during the active part of the study:
- (1) CAT scan to obtain images of the chest arteries and measure the amount of calcium in the artery walls.
- (2) Magnetic resonance imaging scan to obtain images of the coronary and carotid arteries in the chest and neck.
- (3) Electrocardiogram to provide data on current heart function.
- (4) Blood samples to provide data on heart, kidney, and immune system function.
- Participants will be contacted every 2 years in the future for up to 30 years to determine whether they have developed heart disease. Researchers will ask participants to provide contact information for two other people who may likely know how to get in touch with the participant in the future.
|Condition or disease|
|Chronic Granulomatous Disease (CGD)|
|Study Type :||Observational|
|Estimated Enrollment :||550 participants|
|Official Title:||Non-Invasive Assessment of Atherosclerosis in Patients With CGD and Other Disorders of the Immune System|
|Study Start Date :||December 11, 2009|
- To assess the prevalence of atherosclerotic disease in patients with disorders of the immune system compared to the general population. The amount of atherosclerotic disease and its degree of inflammation will be assessed. [ Time Frame: At the end of the study ]
- To assess circulating biomarkers (including lipid profile, MPO, CRP, ESR, TNF alpha, IL-8, and IFN gamma) and demographic factors (e.g., age, gender, smoking, family history) to determine if they are correlated with the development of atheroscle... [ Time Frame: upon study completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063309
|Contact: John I Gallin, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||John I Gallin, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|