Study of the Efficiency of Education About Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome

NCT ID: NCT00337480

Last Updated: 2013-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-09-30

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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conventional

This arm is the conventional way of taking care of patients after an acute coronary syndrome

Group Type NO_INTERVENTION

No interventions assigned to this group

structured

This arm is an active way to monitor and educate patients after their acute coronary syndrome, with the intervention of health members in a House of Education

Group Type ACTIVE_COMPARATOR

education

Intervention Type BEHAVIORAL

education of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity

Interventions

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education

education of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity

Intervention Type BEHAVIORAL

Other Intervention Names

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House of Education Structured network health members

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Resicard

OTHER

Sponsor Role lead

Responsible Party

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Pr Ariel Cohen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ariel Cohen, Pr

Role: PRINCIPAL_INVESTIGATOR

Hopital St Antoine

Locations

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Clinique la Roseraie

Aubervilliers, , France

Site Status

Hopital Lariboisiere

Paris, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Hopital Pitie Salpetriere

Paris, , France

Site Status

Hopital Bichat

Paris, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 24126705 (View on PubMed)

Other Identifiers

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Resicard Prevention

Identifier Type: -

Identifier Source: org_study_id

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