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

• ClinicalTrials.gov Identifier: NCT01075867
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Last Update Posted: April 30, 2020
• Sponsor: University Hospital, Geneva
• Information provided by (Responsible Party): François MACH, University of Bern

Tracking Information

• First Submitted Date: February 24, 2010
• First Posted Date: February 25, 2010
• Last Update Posted Date: April 30, 2020
• Study Start Date: April 2010
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 24, 2010)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 24, 2010)

• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multi-dimensional Prevention Program After Acute Coronary Syndrome (ELIPS) (SPUM-ACS- SP1)
• Official Title: Not Provided

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients Admitted for an Acute Coronary Syndrome
• Condition: Acute Coronary Syndrome
• Intervention: Not Provided

Study Groups/Cohorts

• Control group
  Before ELIPS implementation 12 months follow-up
• Treatment group
  After ELIPS implementation 12 months follow-up

• Publications *: Weidmann L, Obeid S, Mach F, Shahin M, Yousif N, Denegri A, Muller O, Räber L, Matter CM, Lüscher TF. Pre-existing treatment with aspirin or statins influences clinical presentation, infarct size and inflammation in patients with de novo acute coronary syndromes. Int J Cardiol. 2019 Jan 15;275:171-178. doi: 10.1016/j.ijcard.2018.10.050. Epub 2018 Oct 16.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 28, 2020): 2498
• Original Estimated Enrollment (submitted: February 24, 2010): 2400
• Actual Study Completion Date: December 2018
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01075867
• Other Study ID Numbers: SPUM-ACS-SP1
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: François MACH, University of Bern
• Study Sponsor: University Hospital, Geneva
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University Hospital, Geneva
• Verification Date: April 2020