Non-Invasive Assessment of Atherosclerosis in Patients With CGD and Other Disorders of the Immune System
|First Received Date ICMJE||February 4, 2010|
|Last Updated Date||April 28, 2015|
|Start Date ICMJE||December 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01063309 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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 ] [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Non-Invasive Assessment of Atherosclerosis in Patients With CGD and Other Disorders of the Immune System|
|Official Title ICMJE||Non-Invasive Assessment of Atherosclerosis in Patients With CGD and Other Disorders of the Immune System|
- 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.
Heart disease kills more than half a million people in the U.S. each year. Atherosclerosis, the major cause of heart disease, is thought to relate to dysregulated inflammation in the cardiac blood vessels and possibly results from over production of reactive oxygen species (ROS). The rate of atherosclerosis in patients with disorders of the immune system has not been well characterized but is likely to be dramatically different than that seen in the general population. Specifically, patients with Chronic Granulomatous Disease (CGD) may be protected from developing atherosclerosis due to reduced superoxide and other ROS production by phagocytic cells. We hypothesize that patients with CGD are at decreased risk of developing atherosclerosis. The primary objective of this study is to determine the prevalence of atherosclerosis and it s inflammatory characteristics in these and other patients with in-born disorders of immune function. The primary objective will be assessed using imaging techniques to measure coronary artery calcium scores and the presence or absence of soft plaque. Secondary endpoints include physiologic characteristics such as blood pressure as well as circulating biomarkers associated with heart disease such as C-reactive protein and lipid profile. This study may lead to improved understanding of the pathophysiology of atherosclerosis, specifically the role of free radical stress, and could lead to novel therapies for atherosclerosis that may benefit patients with immune disorders and the general population.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Cross-Sectional|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Chronic Granulomatous Disease (CGD)|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||550|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients will be identified for this protocol who are enrolled on existing protocols studying patients with disorders of the immune system who volunteer for participation and who do not have any of the listed exclusion criteria. Patients will remain enrolled on their existing protocol. Normal volunteers will be enrolled as controls on this protocol. They will be recruited through the normal volunteer office which will provide a list of volunteers including their age to allow for inclusion of controls that approximate the study population.
All patients enrolled on this protocol will be over the age of 18 and may be male or female and will be accrued without regard to religion, race or sexual orientation. They must be able to understand and sign informed consent documents and comply with study procedures that include undergoing a CT scan and an MRI scan. Patients who are unable or unwilling to complete one or more of the studies will not be excluded. The available data will be included in the appropriate analysis.
For Participation in MRI-Based Studies Only:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01063309|
|Other Study ID Numbers ICMJE||100029, 10-I-0029|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP