Aneurysms and Carotid Artery Block in Newborns

NCT ID: NCT00646672

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-17
• Study Completion Date: 2010-04-16

Brief Summary

This study will determine the risk of brain aneurysm (abnormal outpouching of a brain artery) in young adults who had their carotid artery tied off as an infant as part of the extracorporeal membrane oxygenation (ECMO) procedure. This procedure is sometimes performed on newborns with lung problems so that they can have oxygen brought to their blood outside the body. ECMO operates similar to a heart-lung machine. Blood drained from the veins has the carbon dioxide removed and oxygen added. The oxygenated blood is then returned to the body through the arteries.

People 18 to 25 years of age who underwent ECMO as an infant at the Children's National Medical Center in Washington, D.C., may be eligible for this study.

Participants undergo the following procedures:

• Medical history and physical and neurological examinations.
• Magnetic resonance imaging (MRI) of the head and neck. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies in the scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, lying still for up to 15 minutes at a time. During part of the procedure, a contrast dye is injected into a vein through a catheter (thin plastic tube) to enhance the images.

Detailed Description

Objective:

To assess whether the hemodynamic stress of long-term common carotid artery occlusion can lead to cerebral aneurysm formation in young adults.

Study population:

100 adults 18-25 years of age who underwent common carotid artery (CCA) occlusion as a neonate as part of the extracorporeal membrane oxygenation (ECMO) procedure performed in the setting of pulmonary insufficiency.

Design:

Patients who underwent CCA occlusion as a neonate for ECMO at Children's National Medical Center will be identified and contacted. The study will be explained and informed consent will be obtained. Subjects will undergo outpatient evaluation to include history and physical, magnetic resonance angiography and magnetic resonance imaging of the head.

Outcome measures:

• Cerebrovascular anatomic anomalies such as cerebral aneurysms and persistent fetal circulation pathways, etc.
• Cerebral perfusion asymmetry on MRI.
• Cerebral parenchymal abnormalities such as stroke.

Conditions

Cerebrovascular Disorder

Study Design

• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Subjects must be 18-25 years of age.

Subjects had VA ECMO as a neonate at Children's National Medical Center.

Subjects must be in good health.

Subjects must provide informed, written consent for participation in this study.

Exclusion Criteria

Subjects with a history or evidence of mental retardation precluding a written consent unless this consent could be obtained from a legal guardian.

Subjects with a history of reaction to MR contrast media or who are unable to have an MRI.

Subjects who underwent carotid artery reconstruction after neonatal ECMO.

Females who are pregnant or nursing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: lead

Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Countries

United States

References

Andrews RJ, Spiegel PK. Intracranial aneurysms. Age, sex, blood pressure, and multiplicity in an unselected series of patients. J Neurosurg. 1979 Jul;51(1):27-32. doi: 10.3171/jns.1979.51.1.0027.

Reference Type: BACKGROUND

PMID: 448414 (View on PubMed)

Bartlett RH, Gazzaniga AB, Jefferies MR, Huxtable RF, Haiduc NJ, Fong SW. Extracorporeal membrane oxygenation (ECMO) cardiopulmonary support in infancy. Trans Am Soc Artif Intern Organs. 1976;22:80-93.

Reference Type: BACKGROUND

PMID: 951895 (View on PubMed)

Burt VL, Whelton P, Roccella EJ, Brown C, Cutler JA, Higgins M, Horan MJ, Labarthe D. Prevalence of hypertension in the US adult population. Results from the Third National Health and Nutrition Examination Survey, 1988-1991. Hypertension. 1995 Mar;25(3):305-13. doi: 10.1161/01.hyp.25.3.305.

Reference Type: BACKGROUND

PMID: 7875754 (View on PubMed)

Other Identifiers

08-N-0095

Identifier Type: -

Identifier Source: secondary_id

080095

Identifier Type: -

Identifier Source: org_study_id