Non-Invasive Assessment of Atherosclerosis in Patients With CGD and Other Disorders of the Immune System
Public ClinicalTrials.gov record NCT01063309. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: * 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. Objectives: \- To study the prevalence of atherosclerosis in patients with immune system disorders, compared with healthy individuals. Eligibility: \- Individuals at least 18 years of age who either have been diagnosed with an immune system disorder or are healthy volunteers. Design: * 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.
Study identification
- NCT ID
- NCT01063309
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 156 participants
Conditions and interventions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 4, 2010
- Primary completion
- Dec 30, 2018
- Completion
- Aug 25, 2020
- Last update posted
- Jul 27, 2021
2010 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01063309, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2021 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01063309 live on ClinicalTrials.gov.