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Trial record 1 of 1 for:    NCT00758810
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Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors (OLIMPIC)

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: NCT00758810
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : June 17, 2009
Sponsor:
Collaborator:
Pfizer
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date September 24, 2008
First Posted Date September 25, 2008
Last Update Posted Date June 17, 2009
Study Start Date October 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2009)
state of secondary prevention measures : Serum (fasting glucose, total cholesterol, HDL and LDL cholesterol, triglycerides, CPK, creatin), nutritional questionnaire, smoking cessation and physical activity [ Time Frame: Inclusion and M12 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors
Official Title Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors, Daily Physical Activity, Dietary Habits and Blood Glucose and Fatty Acids in Coronary Syndromes Patients
Brief Summary

In secondary prevention, the beneficial role of cardiac rehabilitation programs after myocardial infarction, percutaneous coronary intervention or coronary artery bypass is now well established. The large majority of patients don't benefit from cardiac rehabilitation but for those who do, they usually follow an inhospital short health educational program with a sensibilisation to different coronary risk factors like smoking, overweight and inactivity. The impact of these inhospital short health educational programs combined to cardiac rehabilitation has never been totally evaluated, especially the impact on smoking cessation, weight loss and daily physical activity.

Therefore, the present study aims to evaluate the impact at one year on 400 consecutive patients' coronary risk profile of:

  • an inhospital short health educational program alone
  • an inhospital short health educational program combined to cardiac rehabilitation
  • a cardiac rehabilitation program alone
Detailed Description

Classical CV risk factors, quality of life, daily physical activity and energy expenditure, smoking dependency and a daily quantification of fat intake are assessed with previously validated self-administrated questionnaires. Further factors like the lipid profile and glycaemia (with HbA1c in case of diabetes) will also be assessed. These evaluation will take place once at the of the hospitalization for acute coronary events in all patients, once at the end of any of the three rehabilitation programs for the concerned patients and, finally, one year after the hospitalization or the end of the rehabilitation program (mailed questionnaires and biological check-up). At this time, smoking dependency, medication, body mass index, any coronary event or need of coronary revascularization along with the professional ongoing situation (return to work) will be investigated.

As this study aims to evaluate the efficiency of France's clinical practice in spotting most relevant risk factors, the results of the present study could help us to focus the medical and paramedical resources on the modification of specific relevant risk factors.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with acute coronary syndrome or myocardial infarctus
Condition
  • Myocardial Infarction
  • Acute Coronary Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Patients without cardiac rehabilitation
  • 2
    Patients with cardiac rehabilitation
Publications *

*   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: September 24, 2008)
354
Original Actual Enrollment Same as current
Actual Study Completion Date June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • acute coronary syndrome or myocardial infarcts

Exclusion Criteria:

  • misunderstand the questionnaires
  • living in institution
  • severe morbidity
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00758810
Other Study ID Numbers 0608999
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alexis CERISIER, CHU de Saint-Etienne
Study Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators Pfizer
Investigators
Principal Investigator: Alexis CERISIER, MD CHU de Saint-Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date June 2009