Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of the Efficiency of Education About Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome
This study is currently recruiting participants.
Verified by Resicard, May 2008
Sponsored by: Resicard
Information provided by: Resicard
ClinicalTrials.gov Identifier: NCT00337480
  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

MedlinePlus related topics: Weight Control
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
Official Title: A Network to Control Risk Factors After Acute Coronary Syndrome

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:
  • blood pressure less than 140/80mmHg [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • low density lipoproteins cholesterol less than 1g/l [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • diabetes HbA1 less than 7% [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • patient's quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • patient's satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • patient's level of knowledge of the disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • physicians' satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: July 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
conventional: No Intervention
This arm is the conventional way of taking care of patients after an acute coronary syndrome
structured: Active Comparator
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

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

Contacts
Contact: Ariel Cohen, Pr 33-1-49-28-28-86 ariel.cohen@sat.aphp.fr

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

Responsible Party: Resicard ( Dr Assyag )
Study ID Numbers: Resicard Prevention
Study First Received: June 14, 2006
Last Updated: May 22, 2008
ClinicalTrials.gov Identifier: NCT00337480  
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

Study placed in the following topic categories:
Smoking
Obesity
Heart Diseases
Myocardial Ischemia
 Acute Coronary Syndrome
Vascular Diseases
Overweight
Ischemia

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services