Aneurysms and Carotid Artery Block in Newborns

NCT00646672 | Completed

• 2 other identifiers: 08009508-N-0095
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Disorder

Keywords

ECMO; Cerebral Perfusion; Carotid Artery; Aneurysm; Cerebral Circulation; Common Carotid Artery Occlusion

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 448414 BACKGROUND

• 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.

  PMID: 951895 BACKGROUND

• 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.

  PMID: 7875754 BACKGROUND

MeSH Terms

Conditions

Cerebrovascular Disorders; Aneurysm

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 28, 2008
• Study Start: March 17, 2008
• Study Completion: April 16, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-04-16

Locations

US (1)