Aneurysms and Carotid Artery Block in Newborns
|First Received Date ICMJE||March 26, 2008|
|Last Updated Date||April 17, 2010|
|Start Date ICMJE||March 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00646672 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Aneurysms and Carotid Artery Block in Newborns|
|Official Title ICMJE||Assessment of Cerebral Circulation and Perfusion in Adults After Neonatal Carotid Occlusion|
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:
To assess whether the hemodynamic stress of long-term common carotid artery occlusion can lead to cerebral aneurysm formation in young adults.
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Retrospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Cerebrovascular Disorder|
|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||Completed|
|Estimated Completion Date||April 2010|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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.
|Ages||18 Years to 25 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00646672|
|Other Study ID Numbers ICMJE||080095, 08-N-0095|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP