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

Acute Coronary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075867
• Other study ID #: SPUM-ACS-SP1
• Status: Completed
• Start date: April 2010
• Est. completion date: December 2018

Study information

• Verified date: April 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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,.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2498
• Est. completion date: December 2018
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Switzerland	University Hospital	Bern
Switzerland	University Hospitals	Geneva
Switzerland	University Hospital	Lausanne
Switzerland	University Hospital,	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of death and cardiovascular event	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	Process outcome at discharge	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
Secondary	Clinical outcomes at follow-up	Individual data on each of the composite outcome; Cardiovascular mortality	1 year
Secondary	Surrogate outcomes at follow-up	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

External Links

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