Resynchronization of Left Ventricular Contraction After Reimplantation of Anomalous Left Coronary Artery
| Tracking Information | |||||
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| First Received Date ICMJE | December 20, 2005 | ||||
| Last Updated Date | March 14, 2012 | ||||
| Start Date ICMJE | January 2004 | ||||
| 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 NCT00268112 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 | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Resynchronization of Left Ventricular Contraction After Reimplantation of Anomalous Left Coronary Artery | ||||
| Official Title ICMJE | Resynchronization of Left Ventricular Contraction After Re-implantation of Anomalous Left Coronary Artery From the Pulmonary Artery (ALCAPA) Evaluated by Tissue Doppler Imaging | ||||
| Brief Summary | Spontaneous resynchronization of dyskinetic segments of the left ventricle occurs after coronary bypass surgery in adults and has been shown in some children. It is, however, unknown what degree of dyskinesis is likely to be reversible in infants with ischemia from anomalous coronary arteries and what criteria would indicate that a resynchronization strategy of biventricular pacing might be needed. These questions need data from quantitative serial tissue Doppler observations of patients from pre-operative to late post-operative follow-up. |
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| Detailed Description | We have previously studied, at Children's Healthcare of Atlanta, Egleston Hospital, 2 patients with ALCAPA and one other patient is currently enrolled in a prospective study after recent surgery, also at Children's Healthcare of Atlanta. We propose to study these 3 patients with this rare defect concurrently with their routine echocardiographic evaluations. Data will then be taken off-line for analysis. Standard deviations of times to peak contraction velocity will be assessed for twelve cardiac segments. These will be reevaluated at follow up intervals after surgery on previously obtained echocardiograms. Those subjects in whom improvement of cardiac function, Left Ventricular Ejection Fraction (LVEF) and mitral regurgitation is seen will be compared to those in whom no improvement occurs. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Cardiac pediatric patients |
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| Condition ICMJE | Congenital Disorders | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 3 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00268112 | ||||
| Other Study ID Numbers ICMJE | 05-203 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Children's Healthcare of Atlanta | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Healthcare of Atlanta | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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