Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-04-24 @ 9:46 AM
Study NCT ID:
NCT02929550
Status:
COMPLETED
Last Update Posted:
2020-11-25
First Post:
2016-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Guidelines on Cardiovascular and Economic Outcomes With Focus on Lipid Lowering Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065228', 'term': 'Non-Randomized Controlled Trials as Topic'}], 'ancestors': [{'id': 'D018849', 'term': 'Controlled Clinical Trials as Topic'}, {'id': 'D002986', 'term': 'Clinical Trials as Topic'}, {'id': 'D000068456', 'term': 'Clinical Studies as Topic'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5304}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2016-10-07', 'lastUpdatePostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of AMI patients who have achieved target goal of LDL-cholesterol 1.8 mmol/L or not', 'timeFrame': 'AMI patients with one year follow-up year 2013', 'description': 'Treatment gap will be analysed in well-controlled (LDL-C ≤1.8 mmol/L) and non-controlled ( LDL-C \\>1.8 mmol/L) cohort in men and women separately.'}], 'secondaryOutcomes': [{'measure': 'Number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group', 'timeFrame': 'Predicted number of events within a 10 year period', 'description': 'Number of events predicted to occur in the non-controlled group'}, {'measure': 'Health care costs in SEK saved, due to number of predicted CVD events gained if target LDL-cholesterol was achieved in the non-controlled group', 'timeFrame': 'Predicted health care costs within a 10 year period', 'description': 'Health care costs predicted to be gained if the non-controlled group achieved target LDL-cholesterol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiovascular disease', 'Costs', 'Guidelines', 'Lipids', 'Myocardial infarction'], 'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '28814290', 'type': 'RESULT', 'citation': 'Journath G, Hambraeus K, Hagstrom E, Pettersson B, Lothgren M. Predicted impact of lipid lowering therapy on cardiovascular and economic outcomes of Swedish atherosclerotic cardiovascular disease guideline. BMC Cardiovasc Disord. 2017 Aug 16;17(1):224. doi: 10.1186/s12872-017-0659-2.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5559790/pdf/12872_2017_Article_659.pdf', 'label': 'Predicted impact of lipid lowering therapy on cardiovascular and economic outcomes of Swedish atherosclerotic cardiovascular disease guideline.'}]}, 'descriptionModule': {'briefSummary': 'Methods: All patients \\<75 years registered in the Swedish Secondary Prevention after Heart Intensive care Admission registry (SEPHIA), will be followed-up within one year post-myocardia infarction (MI). The REACH risk prediction and a calibrated model for recurrent cardiovascular disease (CVD) events and death will be used to estimate base case, and calibrated CVD outcomes based on gender-specific risk factors. The predicted impact of the LDL-C reduction on the risk of CVD will be based on Cholesterol Treatment Trialists´ Collaboration findings.', 'detailedDescription': 'SWEDEHEART is a Swedish national registry consisting of several sub registries in which patients with acute coronary syndrome are prospectively registered. Patient characteristics, hospital treatments, drug treatments at discharge, and outcome for patients consecutively included and treated at all Swedish coronary care units are collected in this registry.SEPHIA is a sub registry collecting data on secondary prevention and cardiac rehabilitation. Follow-up are registered at six to ten weeks and at 12 to14 months post MI by office visits or phone. Around 80 % of all Swedish acute myocardial infarction (AMI) patients below the age of 75 years are included in this register.\n\nIn this study, a cohort of 5 904 (74% men) registered in the SEPHIA registry and who had one year follow-up during 2013, will be included. Data are aggregated and delivered from the SWEDEHEART/SEPHIA national registry. All patients were informed about their participation in the registry, the follow-up, and their right to decline participation. No written consent was obtained'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'a cohort of 5 904 (74% men) registered in the Swedish Secondary Prevention after Heart Intensive Care Admission (SEPHIA) registry and who have had one year follow-up during 2013', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: All patients with acute myocardial infarction registered in the SEPHIA registry and who had one year follow-up during 2013 -\n\nExclusion Criteria:none\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02929550', 'acronym': 'GuLLD', 'briefTitle': 'Impact of Guidelines on Cardiovascular and Economic Outcomes With Focus on Lipid Lowering Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Predicted Impact on Cardiovascular and Economic Outcomes of Swedish Atherosclerotic Cardiovascular Disease Guideline 2014 With Focus on Lipid Lowering Treatment', 'orgStudyIdInfo': {'id': '2015/4:7'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Well-controlled cohort (LDL-C ≤ 1.8 mmol/L)', 'description': 'Individuals in the Swedish Secondary Prevention after Heart intensive care Admission (SEPHIA) is a sub register within SWEDEHEART collecting data on secondary prevention and cardiac rehabilitation with well-controlled LDL-cholesterol', 'interventionNames': ['Other: Well-controlled']}, {'label': 'Non-controlled cohort', 'description': 'Individuals in the Swedish Secondary Prevention after Heart intensive care Admission (SEPHIA) is a sub register within SWEDEHEART collecting data on secondary prevention and cardiac rehabilitation and with not well-controlled LDL-C'}], 'interventions': [{'name': 'Well-controlled', 'type': 'OTHER', 'otherNames': ['Non-controlled'], 'description': 'Both groups got treatment but well-controlled reached target of LDL-C\\<1.8 mmol/l', 'armGroupLabels': ['Well-controlled cohort (LDL-C ≤ 1.8 mmol/L)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gunilla Journath, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoc', 'investigatorFullName': 'Gunilla Journath', 'investigatorAffiliation': 'Karolinska Institutet'}}}}