Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 3:40 PM
Study NCT ID:
NCT01276132
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2011-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2011-01-10', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate clinical outcomes, safety, and satisfaction of patients who have participated in a same-day outpatient percutaneous coronary artery intervention program', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['percutaneous coronary artery intervention', 'coronary disease'], 'conditions': ['To Evaluate Clinical Outcomes, Safety, and Satisfaction of Patients Who Have Participated in a Same Day Outpatient Percutaneous Coronary Artery Intervention']}, 'descriptionModule': {'briefSummary': 'Subjects in this study have recently had or are scheduled for a (percutaneous coronary intervention) PCI as part of their normal, routine medical care. This procedure should restore the blood flow in the vessels of the heart.\n\nRecent studies have shown that stable patients who undergo PCI and are discharged home after 4 hours of observation do not suffer any more complications compared to patients who stay in the hospital overnight. In addition, studies suggest that patients express increased satisfaction at being discharged after 4 hours.\n\nThe University of Chicago is one of the first US medical centers to institute a formal program of same-day discharge after PCI. This study will seek, through a analysis of medical information and satisfaction questionnaires, to assess whether this particular same-day discharge program can improve patient satisfaction and preserve patient safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Every patient who presents to the Cardiac Catheterization Laboratory for coronary angiography will be given the opportunity to participate in this program. The determination on whether or not a patient is selected to undergo Same-Day PCI is based on the clinical decision of the practicing physician according to conventionally accepted inclusion and exclusion criteria. The decision on whether or not to participate in the questionnaire study will not affect any treatment decisions. The only exclusion criteria will be if the patient declines participation. The investigators would like to enroll 250 patients over a three year period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 and up\n* undergoes coronary angiography in the Cardiac Catheterization Laboratory\n\nExclusion Criteria:\n\n* if the subject declines participation'}, 'identificationModule': {'nctId': 'NCT01276132', 'briefTitle': 'Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program', 'orgStudyIdInfo': {'id': '10-291-A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects who are designated to receive same-day PCI'}, {'label': 'Subjects who had been admitted to the hospital after their PCI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Atman Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}