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

April 28, 2020 updated by: François MACH, University Hospital, Geneva

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,.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2498

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland
        • University Hospital
      • Geneva, Switzerland
        • University Hospitals
      • Lausanne, Switzerland
        • University Hospital
      • Zürich, Switzerland
        • University Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients Admitted for an Acute Coronary Syndrome

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
Before ELIPS implementation 12 months follow-up
Treatment group
After ELIPS implementation 12 months follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
Clinical outcomes at follow-up
Time Frame: 1 year

Individual data on each of the composite outcome

Cardiovascular mortality
1 year
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPUM-ACS-SP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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