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Sponsors and Collaborators: |
Centre Hospitalier Universitaire de Saint Etienne Pfizer |
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Information provided by: | Centre Hospitalier Universitaire de Saint Etienne |
ClinicalTrials.gov Identifier: | NCT00758810 |
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:
Condition |
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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 |
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 |
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1
Patients without cardiac rehabilitation
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2
Patients with cardiac rehabilitation
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
patients with acute coronary syndrome or myocardial infarctus
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Alexis CERISIER, MD | CHU de Saint-Etienne |
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 |
Health Education Myocardial Infarction Acute Coronary Syndrome Quality of Life |
Necrosis Heart Diseases Myocardial Ischemia Acute Coronary Syndrome Vascular Diseases |
Neoplasm Metastasis Quality of Life Ischemia Infarction Myocardial Infarction |
Necrosis Disease Heart Diseases Pathologic Processes Myocardial Ischemia Syndrome |
Acute Coronary Syndrome Vascular Diseases Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |