Clinical trial NCT00337480: Study of the Efficiency of Education About Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome
Official title: A Network to Control Risk Factors After Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndrome
cardiovascular risk factors
smoking habits
obesity
sedentary lifestyle
overweight
education
follow up after hospitalization
Lead sponsor: Resicard
Sponsor class: OTHER
First posted: 2006-06-16
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the follow up of patients with acute coronary syndrome and modifiable cardiovascular risk factors is efficient based on outpatients visits in a House of Education, underlining the importance of nicotinic weaning, weight loss and physical activity practice.

Detailed description: 1. Objectives

   1. The main purpose of this study is to evaluate the efficiency of "Resicard Prevention", which is a structured health network within a House of Education located outside of the hospital and based on outpatients' visits.
   2. Another purpose is to facilitate and optimize physicians and all health members communication around the acute coronary syndrome patients.
2. Method

   * After randomization, patients are directed to one of the two following groups: the conventional network group or the structured network group. Six and twelve months after their hospitalization, a blood test will be performed and their weight, blood pressure, waist measurement and cardiac frequency will be recorded in order to monitor patients' cardiovascular risk factors.In any case, patients receive optimal care with the participation of different health members (such as nurses, doctors, dietician...).

     a-The conventional network group
   * Patients are taken care of, according to good medical practice by their usual general practitioner and cardiologist. The frequency of consultations is set up according to symptoms. The follow up of patients is optimized as they are taken care of by a multidisciplinary health team.

     b-The structured network group
   * Patients in this group will have to consult their general practitioner and cardiologist within the first month after their hospitalization. Two forms summarizing their hospitalization facts and the objectives of the risk factors correction will be electronically sent to their general practitioner, to their cardiologist and to the House of Education. Patients have appointments at the House of Education where a multidisciplinary team (with a nurse, a dietician,...) welcomes them. They set up a schedule according to patients' needs:
   * consultation for nicotinic weaning
   * some dietary advice in order to lose weight
   * some specific advice on diabetes and/or hypercholesteremia
   * information about high blood pressure
   * some advice to pursue a regular physical activity After each appointment at the House of Education, a form summarizing the risk factors will be provided electronically to patients' general practitioner and cardiologist.
3. Conclusion -This evaluation protocol should demonstrate the efficiency of a health network based on the correction of modifiable cardiovascular risk factors within a House of Education in secondary prevention after an acute coronary syndrome.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* hospitalization for acute coronary syndrome (ST segment elevation myocardial infarction, non-ST segment elevation myocardial infarction, unstable angina)
* cardiovascular risk factors during hospitalization (active and current smoking, sedentary lifestyle, obesity, overweight)
* autonomy
* agreement to visit the House of Education
* signature of a assent

Exclusion Criteria:

* lack of understanding or phrasing
* refusal to sign the consent form

Primary outcomes:
measure: nicotinic weaning
timeFrame: 1year
measure: weight loss at least 5%
timeFrame: 1 year
measure: waist reduction at least 4%
timeFrame: 1 year
measure: physical activity at least 30 minute per day (3h per week)
timeFrame: 1 year
Secondary outcomes:
measure: correction of nicotinic addiction, overweigh and lack of physical activity all together
timeFrame: 1 year
measure: correction of each risk factor of primary outcome, individually
timeFrame: 1 year
measure: correction of the other risk factors
timeFrame: 1 year
measure: diabetes mellitus with HbA1C inferior to 7%
timeFrame: 1 year
measure: quality of life with mental and physical scores (SF-12)
timeFrame: 1 year
measure: patient's level of knowledge of the disease: number of correct answers to 19 questions
timeFrame: 1 year
Other outcomes:
Locations:
city: Aubervilliers
country: France
facility: Clinique la Roseraie
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Hopital Tenon
Study officials:
affiliation: Hopital St Antoine
name: Ariel Cohen, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen A, Assyag P, Boyer-Chatenet L, Cohen-Solal A, Perdrix C, Dalichampt M, Michel PL, Montalescot G, Ravaud P, Steg PG, Boutron I; Reseau Insuffisance Cardiaque (RESICARD) PREVENTION Investigators. An education program for risk factor management after an acute coronary syndrome: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):40-8. doi: 10.1001/jamainternmed.2013.11342.