Multi-dimensional Prevention Program After Acute Coronary Syndrome (ELIPS) (SPUM-ACS- SP1)
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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 |
- 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.
- 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 |
Patients Admitted for an Acute Coronary Syndrome
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| Contact: François Mach | +41 (0) 22 372 71 91 | francois.mach@hcuge.ch |
| Contact: Baris Gencer | baris.gencer@hcuge.ch |
| 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 | |
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: | January 27, 2013 |
| 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 May 23, 2013