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

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,.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Bern, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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
Clinical outcomes at follow-up

Time frame: 1 year

Individual data on each of the composite outcome

Cardiovascular mortality
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)

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2018
First posted: Feb 25, 2010
Registry last updated: Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed