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

A Network to Control Risk Factors After Acute Coronary Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Behavioral: education

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.

• Study Type: Interventional
• Enrollment (Actual): 504
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aubervilliers, France, 93300
    • Clinique la Roseraie
  • Paris, France, 75010
    • Hopital Lariboisiere
  • Paris, France, 75020
    • Hopital Tenon
  • Paris, France, 75013
    • Hopital Pitie Salpetriere
  • Paris, France, 75018
    • Hopital Bichat
  • Paris, France, 75011
    • Hôpital Saint Antoine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: conventional; This arm is the conventional way of taking care of patients after an acute coronary syndrome
Active Comparator: 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	Behavioral: education; education of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity; Other Names: House of Education; Structured network; health members

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
nicotinic weaning	1year
weight loss at least 5%	1 year
waist reduction at least 4%	1 year
physical activity at least 30 minute per day (3h per week)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correction of nicotinic addiction, overweigh and lack of physical activity all together		1 year
correction of each risk factor of primary outcome, individually		1 year
correction of the other risk factors	arterial hypertension inferior to 140/90 Hgmm; low density lipoprotein cholesterol inferior to 1g/l	1 year
diabetes mellitus with HbA1C inferior to 7%		1 year
quality of life with mental and physical scores (SF-12)		1 year
patient's level of knowledge of the disease: number of correct answers to 19 questions		1 year

Collaborators and Investigators

• Sponsor: Resicard
• Investigators: Principal Investigator: Ariel Cohen, Pr, Hopital St Antoine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: June 14, 2006
• First Submitted That Met QC Criteria: June 14, 2006
• First Posted (Estimate): June 16, 2006

Study Record Updates

• Last Update Posted (Estimate): April 15, 2013
• Last Update Submitted That Met QC Criteria: April 12, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: obesity; overweight; acute coronary syndrome; education; cardiovascular risk factors; sedentary lifestyle; smoking habits; follow up after hospitalization
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: Resicard Prevention