Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-03 @ 2:52 PM
Study NCT ID:
NCT01075867
Status:
COMPLETED
Last Update Posted:
2020-04-30
First Post:
2010-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-dimensional Prevention Program After Acute Coronary Syndrome (ELIPS) (SPUM-ACS- SP1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], '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': 2498}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-28', 'studyFirstSubmitDate': '2010-02-24', 'studyFirstSubmitQcDate': '2010-02-24', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite of death and cardiovascular event', 'timeFrame': '1 year', 'description': 'Composite of\n\n* death from any cause,\n* myocardial infarction,\n* documented unstable angina requiring rehospitalization,\n* revascularization (performed at least 30 days after randomization),\n* documented new or worsen lower limb ischemia,\n* stroke\n* transient cerebral ischemic accident.'}], 'secondaryOutcomes': [{'measure': 'Process outcome at discharge', 'timeFrame': '1 year', 'description': 'Prescription of recommended treatment at discharge:\n\n* Cardiovascular medication (Lipid lowering treatment, beta-blockers, antithrombotic therapy (acetylsalicylic acid, clopidogrel), ACE-inhibitors, AT-II antagonists)\n* Smoking cessation counseling during hospital stay\n* Referral to cardiovascular rehabilitation center\n* Use of educational booklet at discharge'}, {'measure': 'Clinical outcomes at follow-up', 'timeFrame': '1 year', 'description': 'Individual data on each of the composite outcome\n\nCardiovascular mortality'}, {'measure': 'Surrogate outcomes at follow-up', 'timeFrame': '1 year', 'description': 'Cardiovascular risk factor control at follow-up:\n\n* arterial blood pressure,\n* fasting blood glucose,\n* blood lipids (LDL-Cholesterol, HDL-Cholesterol, Triglycerides),\n* smoking cessation (7-days point prevalence at one year and continuous abstinence since hospitalisation)\n* body mass index reduction\n* abdominal waist reduction\n\nQuality of life and utility (EQ-5D questionnaire) Adherence to medication (MAS questionnaire) Physical activity (IPAQ questionnaire) Motivation to adopt therapeutic lifestyle attitudes (smoking cessation, diet change, physical activity)'}]}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '30344063', 'type': 'DERIVED', 'citation': 'Weidmann L, Obeid S, Mach F, Shahin M, Yousif N, Denegri A, Muller O, Raber L, Matter CM, Luscher TF. Pre-existing treatment with aspirin or statins influences clinical presentation, infarct size and inflammation in patients with de novo acute coronary syndromes. Int J Cardiol. 2019 Jan 15;275:171-178. doi: 10.1016/j.ijcard.2018.10.050. Epub 2018 Oct 16.'}], 'seeAlsoLinks': [{'url': 'http://www.elips.ch', 'label': 'Related Info'}, {'url': 'http://www.spum-acs.ch', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate the effectiveness of the ELIPS programme (Multi-dimEnsionaL preventIon Program after Acute coronary Syndrome), which aims at improving quality of care of patients admitted to hospital with Acute Coronary Syndrome (ACS) in the Swiss setting. The program targets an increase in prescription rates by physicians and long term medication adherence and adoption of healthy lifestyle attitudes by patients.\n\nThe program is dedicated to caregivers to increase their application of guidelines into practice, to increase their confidence in therapeutic education of patients, and to patients to improve their understanding of ACS and its treatment and to increase their motivation for long term treatment,.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients Admitted for an Acute Coronary Syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years\n* Admitted for an ACS, that is with symptoms compatible with angina pectoris (chest pain, breathlessness) and at least one of the following 3 features : a) Elevation or depression of the ST segment, inverted T waves or dynamic changes in the repolarization phase b) Positive troponin c) Known coronary artery disease. A significant coronary artery disease must be confirmed angiographically.\n\nExclusion Criteria:\n\n* Severe physical disability or dement\n* Less than 1 year of life expectancy for non cardiac reason'}, 'identificationModule': {'nctId': 'NCT01075867', 'briefTitle': 'Multi-dimensional Prevention Program After Acute Coronary Syndrome (ELIPS) (SPUM-ACS- SP1)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'orgStudyIdInfo': {'id': 'SPUM-ACS-SP1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Before ELIPS implementation 12 months follow-up'}, {'label': 'Treatment group', 'description': 'After ELIPS implementation 12 months follow-up'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital,', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pr', 'investigatorFullName': 'François MACH', 'investigatorAffiliation': 'University of Bern'}}}}