Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-28 @ 4:57 AM
Study NCT ID:
NCT04216433
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2019-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 394}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2019-12-30', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2000 to 2009', 'description': 'time (in days) from first AAA surgery to death (any cause)'}, {'measure': 'Time to re-operation', 'timeFrame': '2000 to 2009', 'description': 'time (in days) from first AAA surgery to AAA re-operation'}, {'measure': 'Time to rupture', 'timeFrame': '2000 to 2009', 'description': 'time (in days) from first AAA surgery to AAA rupture'}], 'secondaryOutcomes': [{'measure': 'Type of AAA surgery', 'timeFrame': 'day of surgery', 'description': 'either open or endovascular AAA surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abdominal Aortic Aneurism']}, 'descriptionModule': {'briefSummary': 'In the spirit of improving patient safety and quality of healthcare in our region, the Dallas-Fort Worth Hospital Council Education and Research Foundation (Foundation) and Baylor Research Institute sought and obtained federal funding support (AHRQ grant) to develop an Abdominal Aortic Aneurism (AAA) surgery registry in North Texas. Participating centers will directly benefit from this project and will have access to a de-identified version of the registry data through their collaboration. These data may be used for quality improvement initiatives and/or to conduct your own research. In summary, this effort represents a substantial investment (with no costs to facilities) in improving outcomes for patients with AAA.', 'detailedDescription': 'Currently, little is known about who receives which type of surgery. What data are available are largely from single-centre studies, with study populations of a few hundred to a thousand patients, comparing outcomes for open and endovascular repair and collecting patient characteristic data largely for risk adjustment. Data on endovascular vs open AAA repair from the population-based registry will provide important information regarding the current use of these two treatment strategies, as well as allowing comparison of long-term outcomes for each according to different patient characteristics.\n\nThe proposed registry has the potential to provide means for internal quality assessment for the participating institutions. The de-identified registry will be made available to researchers at their request. This registry, focusing on AAA in the Dallas-Fort Worth metroplex, will provide data with the potential to improve treatments for more than 800,000 patients in the US.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women who received endovascular or open AAA repair (primary/secondary procedure codes: ICD-9=38.44 for open, ICD-9=39.71 for endovascular repair) at any of the 138 Dallas-Fort Worth area hospitals that report AAA data to the DFWHC Data Initiative.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women who received endovascular or open AAA repair (primary/secondary procedure codes: ICD-9=38.44 for open, ICD-9=39.71 for endovascular repair) at any of the 138 Dallas-Fort Worth area hospitals that report AAA data to the DFWHC Data Initiative.\n* patients age 50 years old or older.\n\nExclusion Criteria:\n\n* Patients with HIV and substance abuse\n* Patients with substance abuse\n* Patients \\> 50 years old'}, 'identificationModule': {'nctId': 'NCT04216433', 'acronym': 'AAA', 'briefTitle': 'A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)', 'orgStudyIdInfo': {'id': '2012.00.591.A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'endovascular surgery', 'type': 'PROCEDURE', 'description': 'an innovative, less invasive procedure used to treat problems affecting the blood vessels, such as an aneurysm, which is a swelling or "ballooning" of the blood vessel. The surgery involves making a small incision near each hip to access the blood vessels.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Health System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Robert Feldtman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DFW Vascular Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}