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Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors (OLIMPIC)
This study has been completed.
First Received: September 24, 2008   Last Updated: June 16, 2009   History of Changes
Sponsors and Collaborators: Centre Hospitalier Universitaire de Saint Etienne
Pfizer
Information provided by: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00758810
  Purpose

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

Condition
Myocardial Infarction
Acute Coronary Syndrome

Study Type: Observational
Study Design: Cohort, Prospective
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 354
Study Start Date: October 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients without cardiac rehabilitation
2
Patients with cardiac rehabilitation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with acute coronary syndrome or myocardial infarctus

Criteria

Inclusion Criteria:

  • acute coronary syndrome or myocardial infarcts

Exclusion Criteria:

  • misunderstand the questionnaires
  • living in institution
  • severe morbidity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758810

Locations
France
CHU de Saint-Etienne
SAINT-ETIENNE, France, 42000
CH de Firminy
FIRMINY, France, 42700
CH de Feurs
FEURS, France, 42110
Centre Médical de Chavanne
SAINT-CHAMOND, France, 42400
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Pfizer
Investigators
Principal Investigator: Alexis CERISIER, MD CHU de Saint-Etienne
  More Information

Publications:
De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J, Ebrahim S, Faergeman O, Graham I, Mancia G, Manger Cats V, Orth-Gomér K, Perk J, Pyörälä K, Rodicio JL, Sans S, Sansoy V, Sechtem U, Silber S, Thomsen T, Wood D; Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2003 Sep;24(17):1601-10. No abstract available.
AHA; ACC; National Heart, Lung, and Blood Institute; Smith SC Jr, Allen J, Blair SN, Bonow RO, Brass LM, Fonarow GC, Grundy SM, Hiratzka L, Jones D, Krumholz HM, Mosca L, Pearson T, Pfeffer MA, Taubert KA. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update endorsed by the National Heart, Lung, and Blood Institute. J Am Coll Cardiol. 2006 May 16;47(10):2130-9. No abstract available.
Balady GJ, Williams MA, Ades PA, Bittner V, Comoss P, Foody JM, Franklin B, Sanderson B, Southard D; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Epidemiology and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism; American Association of Cardiovascular and Pulmonary Rehabilitation. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2007 May 22;115(20):2675-82. Epub 2007 May 18.

Responsible Party: CHU de Saint-Etienne ( Alexis CERISIER )
Study ID Numbers: 0608999
Study First Received: September 24, 2008
Last Updated: June 16, 2009
ClinicalTrials.gov Identifier: NCT00758810     History of Changes
Health Authority: France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Health Education
Myocardial Infarction
Acute Coronary Syndrome
Quality of Life

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Neoplasm Metastasis
Quality of Life
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Necrosis
Disease
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Syndrome
Acute Coronary Syndrome
Vascular Diseases
Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on September 11, 2009