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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
François MACH, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01075867
First received: February 24, 2010
Last updated: March 17, 2014
Last verified: January 2014
  Purpose

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
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • composite of death and cardiovascular event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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:
  • Process outcome at discharge [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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

  • Clinical outcomes at follow-up [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Individual data on each of the composite outcome

    Cardiovascular mortality


  • Surrogate outcomes at follow-up [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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)



Estimated Enrollment: 3500
Study Start Date: April 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control group
Before ELIPS implementation 12 months follow-up
Treatment group
After ELIPS implementation 12 months follow-up

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075867

Contacts
Contact: François Mach +41 (0) 22 372 71 91 francois.mach@hcuge.ch
Contact: Baris Gencer baris.gencer@hcuge.ch

Locations
Switzerland
University Hospital Recruiting
Bern, Switzerland
Contact: Pierre-Frédéric Keller, MD         
Contact: Stephan Windecker         
Sub-Investigator: Peter Jüni, MD         
Sub-Investigator: Lorenz Raeber, MD         
University Hospitals Recruiting
Geneva, Switzerland
Contact: François Mach, MD         
Contact: David Carballo, MD         
Sub-Investigator: Sebastian Carballo, MD         
Sub-Investigator: David Carballo, MD         
Sub-Investigator: Thomas Perneger, MD         
Sub-Investigator: Marco Roffi, MD         
Sub-Investigator: Baris Gencer, MD         
University Hospital Recruiting
Lausanne, Switzerland
Contact: Nicolas Rodondi, MD         
Sub-Investigator: Reto Auer, MD         
University Hospital, Recruiting
Zürich, Switzerland
Contact: Thomas F Luscher, MD         
Contact: Christian Matter, MD         
Sub-Investigator: Roland Klingenberg, MD         
Sponsors and Collaborators
François MACH
  More Information

Additional Information:
No publications provided

Responsible Party: François MACH, Pr, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01075867     History of Changes
Other Study ID Numbers: SPUM-ACS-SP1
Study First Received: February 24, 2010
Last Updated: March 17, 2014
Health Authority: Switzerland: Ethics Committee

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014