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

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT01075867
• Lead Sponsor: University Hospital, Geneva

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,.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Study Start: 2010-04
• Primary Completion: 2013-12
• Study Completion: 2018-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2498

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite of death and cardiovascular event	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

Name	Time	Method
Clinical outcomes at follow-up	1 year	Individual data on each of the composite outcome; Cardiovascular mortality
Process outcome at discharge	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
Surrogate outcomes at follow-up	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)

Trial Locations

Locations (3)

University Hospital; 🇨🇭 Lausanne, Switzerland

University Hospital,; 🇨🇭 Zürich, Switzerland

University Hospitals; 🇨🇭 Geneva, Switzerland