Non-Invasive Assessment of Atherosclerosis in Patients With CGD and Other Disorders of the Immune System

Completed

Conditions studied: Atherosclerosis, Chronic Granulomatous Disease (CGD)

In brief

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.

Key facts

Study ID

NCT01063309

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

156

Starts

2010-01-05

Expected to finish

2020-08-26

Last updated by the study team

2021-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• For Participation in MRI-Based Studies Only:
• Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:
• Implanted cardiac pacemaker or defibrillator
• Cochlear Implants
• Ocular foreign body (i.e., metal shavings)
• Embedded shrapnel fragments
• Central nervous system aneurysm clips
• Implanted neural stimulator
• Medical infusion pumps
• Any implanted device that is incompatible with MRI
• Patients whose medical condition is such that in the referring physicians estimation, they could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and dyspnea at rest.
• Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.) or who require more than oral sedation (i.e. IV sedation) for anxiety associate with MRI studies.
• Pregnant or lactating women are excluded from this study because excessive exposure of the developing human fetus and child to radiation and/or intravenous contrast agents can be detrimental.
• Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination.
• For Gadolinium-Based MRI Studies Only:
• History of severe allergic reaction to gadolinium contrast agents despite the use of premedication with an anti-histaminic and/or corticosteroid.
• eGFR less than 60mL/min
• Serum creatinine greater than 3.0 mg/dl
• For Iodine-Based Contrast CT Studies Only:
• Contraindication to the use of iodine based CT contrast agents:
• Serum creatinine greater than 1.4 mg/dl
• History of multiple myeloma
• Use of metformin-containing products less than 24 hours prior to contrast administration
• History of significant allergic reaction to CT contrast agents despite the use of premedication with an anti-histaminic and cortisone.
• For Coronary CT Angiography Only:

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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