Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-30 @ 1:56 PM
Study NCT ID:
NCT01545206
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
2012-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Reducing Door-to-balloon Time in ST-elevation Myocardial Infarction Cause Less Cost?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-05', 'studyFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2012-03-05', 'lastUpdatePostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute STEMI', 'Primary Percutaneous Coronary Arterial Intervention']}, 'descriptionModule': {'briefSummary': 'The investigators tried to determined whether the less D2B time led to costs savings benefited insurance payer and better outcomes to patients.', 'detailedDescription': 'The relationship between the quality of care and costs has been discussed widely. Higher costs of care did not bring better outcomes, vice versa. However, as the rising spending of health care, the health care providers, insurance payers, governments, and consumers begin to pursue the higher quality of cares with lowest costs. In surgical experiences, improving the process of care succeeded to improve the quality of care and reduce the costs.\n\nIn patients with acute ST-Segment elevation myocardial infarction (STEMI), A Door-to-Balloon (D2B) time of less than 90 minutes has been established as the gold standard for primary percutaneous coronary intervention (PCI) and was associated with lower in-hospital mortality.9 Only less literatures discussed the costs and the quality of care in acute STEMI, and whether improving processes of care associated with lower costs was still controversial. The Premier Hospital Quality Incentive Demonstration (PHQID) in United State improved the processes of care but had not a significant effect on cost. Another single hospital experience in Indiana, USA, showed that the reducing D2B time in STEMI decreased the insurance payments as well as the total hospital costs. However, this study design was before-and-after intervention analysis, did not actually measure the impact of D2B time. Besides, the payment system in this study was prospective payment, not fee-for-service payment in Taiwan.\n\nIn this study, we tried to determined whether the less D2B time led to costs savings benefited insurance payer and better outcomes to patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient presented between Feb. 1, 2007 and Jul. 31, 2009 at Far Eastern Memory Hospital for acute STEMI and unwent primary PCI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self visit\n* acute STEMI by ECG definition\n\nExclusion Criteria:\n\n* non-diagnosis on first ECG\n* transferred\n* diagnostic angiogram only'}, 'identificationModule': {'nctId': 'NCT01545206', 'briefTitle': 'Dose Reducing Door-to-balloon Time in ST-elevation Myocardial Infarction Cause Less Cost?', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Better Quality With Less Cost? A Single Hospital Experience on Reducing Door-to-balloon Time in ST-elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': '100046-E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute STEMI, Primpary PCI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '220', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chieh-Min Fan, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Far Eastern Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Chieh-Min Fan', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}