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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
education
Sponsored by
Resicard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, cardiovascular risk factors, smoking habits, obesity, sedentary lifestyle, overweight, education, follow up after hospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique la Roseraie
  • Hopital Lariboisiere
  • Hopital Saint Antoine
  • Hopital Pitie Salpetriere
  • Hopital Bichat
  • Hopital Tenon

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

conventional

structured

Arm Description

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

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

Outcomes

Primary Outcome Measures

nicotinic weaning
weight loss at least 5%
waist reduction at least 4%
physical activity at least 30 minute per day (3h per week)

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2006
Last Updated
April 12, 2013
Sponsor
Resicard
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1. Study Identification

Unique Protocol Identification Number
NCT00337480
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Resicard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Objectives 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. Another purpose is to facilitate and optimize physicians and all health members communication around the acute coronary syndrome patients. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
acute coronary syndrome, cardiovascular risk factors, smoking habits, obesity, sedentary lifestyle, overweight, education, follow up after hospitalization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional
Arm Type
No Intervention
Arm Description
This arm is the conventional way of taking care of patients after an acute coronary syndrome
Arm Title
structured
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
education
Other Intervention Name(s)
House of Education, Structured network, health members
Intervention Description
education of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity
Primary Outcome Measure Information:
Title
nicotinic weaning
Time Frame
1year
Title
weight loss at least 5%
Time Frame
1 year
Title
waist reduction at least 4%
Time Frame
1 year
Title
physical activity at least 30 minute per day (3h per week)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
correction of nicotinic addiction, overweigh and lack of physical activity all together
Time Frame
1 year
Title
correction of each risk factor of primary outcome, individually
Time Frame
1 year
Title
correction of the other risk factors
Description
arterial hypertension inferior to 140/90 Hgmm; low density lipoprotein cholesterol inferior to 1g/l
Time Frame
1 year
Title
diabetes mellitus with HbA1C inferior to 7%
Time Frame
1 year
Title
quality of life with mental and physical scores (SF-12)
Time Frame
1 year
Title
patient's level of knowledge of the disease: number of correct answers to 19 questions
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel Cohen, Pr
Organizational Affiliation
Hopital St Antoine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique la Roseraie
City
Aubervilliers
ZIP/Postal Code
93300
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75011
Country
France
Facility Name
Hopital Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24126705
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.
Results Reference
derived

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

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