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Multi-dimensional Prevention Program After Acute Coronary Syndrome (ELIPS) (SPUM-ACS- SP1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01075867
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
François MACH, University of Bern

Study Description
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Brief Summary:

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.

The 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,.


Condition or disease
Acute Coronary Syndrome

Study Design
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Study Type : Observational
Actual Enrollment : 2498 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2018
Groups and Cohorts
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Group/Cohort
Control group
Before ELIPS implementation 12 months follow-up
Treatment group
After ELIPS implementation 12 months follow-up


Outcome Measures
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Primary Outcome Measures :
  1. composite of death and cardiovascular event [ Time Frame: 1 year ]

    Composite of

    • death from any cause,
    • myocardial infarction,
    • documented unstable angina requiring rehospitalization,
    • revascularization (performed at least 30 days after randomization),
    • documented new or worsen lower limb ischemia,
    • stroke
    • transient cerebral ischemic accident.


Secondary Outcome Measures :
  1. Process outcome at discharge [ Time Frame: 1 year ]

    Prescription of recommended treatment at discharge:

    • Cardiovascular medication (Lipid lowering treatment, beta-blockers, antithrombotic therapy (acetylsalicylic acid, clopidogrel), ACE-inhibitors, AT-II antagonists)
    • Smoking cessation counseling during hospital stay
    • Referral to cardiovascular rehabilitation center
    • Use of educational booklet at discharge

  2. Clinical outcomes at follow-up [ Time Frame: 1 year ]

    Individual data on each of the composite outcome

    Cardiovascular mortality


  3. Surrogate outcomes at follow-up [ Time Frame: 1 year ]

    Cardiovascular risk factor control at follow-up:

    • arterial blood pressure,
    • fasting blood glucose,
    • blood lipids (LDL-Cholesterol, HDL-Cholesterol, Triglycerides),
    • smoking cessation (7-days point prevalence at one year and continuous abstinence since hospitalisation)
    • body mass index reduction
    • abdominal waist reduction

    Quality 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)



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients Admitted for an Acute Coronary Syndrome
Criteria

Inclusion Criteria:

  • Patients >18 years
  • 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.

Exclusion Criteria:

  • Severe physical disability or dement
  • Less than 1 year of life expectancy for non cardiac reason
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075867


Locations
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Switzerland
University Hospital
Bern, Switzerland
University Hospitals
Geneva, Switzerland
University Hospital
Lausanne, Switzerland
University Hospital,
Zürich, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: François MACH, Pr, University of Bern
ClinicalTrials.gov Identifier: NCT01075867    
Other Study ID Numbers: SPUM-ACS-SP1
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases