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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01075867
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : April 30, 2020
Sponsor:
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
Change History
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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