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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pr Ariel Cohen, Resicard
ClinicalTrials.gov Identifier:
NCT00337480
First received: June 14, 2006
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Behavioral: education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Network to Control Risk Factors After Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by Resicard:

Primary Outcome Measures:
  • nicotinic weaning [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • weight loss at least 5% [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • waist reduction at least 4% [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • physical activity at least 30 minute per day (3h per week) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • correction of nicotinic addiction, overweigh and lack of physical activity all together [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • correction of each risk factor of primary outcome, individually [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • correction of the other risk factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    arterial hypertension inferior to 140/90 Hgmm; low density lipoprotein cholesterol inferior to 1g/l

  • diabetes mellitus with HbA1C inferior to 7% [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • quality of life with mental and physical scores (SF-12) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • patient's level of knowledge of the disease: number of correct answers to 19 questions [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 504
Study Start Date: July 2006
Study Completion Date: September 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337480

Locations
France
Clinique la Roseraie
Aubervilliers, France, 93300
Hopital Bichat
Paris, France, 75018
Hopital Tenon
Paris, France, 75020
Hopital Lariboisiere
Paris, France, 75010
Hopital Pitie Salpetriere
Paris, France, 75013
Hopital Saint Antoine
Paris, France, 75011
Sponsors and Collaborators
Resicard
Investigators
Principal Investigator: Ariel Cohen, Pr Hopital St Antoine
  More Information

No publications provided by Resicard

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Ariel Cohen, professor, Resicard
ClinicalTrials.gov Identifier: NCT00337480     History of Changes
Other Study ID Numbers: Resicard Prevention
Study First Received: June 14, 2006
Last Updated: April 12, 2013
Health Authority: France: Institutional Ethical Committee

Keywords provided by Resicard:
acute coronary syndrome
cardiovascular risk factors
smoking habits
obesity
sedentary lifestyle
overweight
education
follow up after hospitalization

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014