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Completed

NCT Number: NCT00337480

Study of the Efficiency of Education About Cardiovascular Risk Factors in Patients After an 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique la Roseraie, Aubervilliers, France

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral

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

Other names: House of Education, Structured network, health members

Primary outcomes

  1. nicotinic weaning

    Time frame: 1year

  2. weight loss at least 5%

    Time frame: 1 year

  3. waist reduction at least 4%

    Time frame: 1 year

  4. physical activity at least 30 minute per day (3h per week)

    Time frame: 1 year

Secondary outcomes

  1. correction of nicotinic addiction, overweigh and lack of physical activity all together

    Time frame: 1 year

  2. correction of each risk factor of primary outcome, individually

    Time frame: 1 year

  3. correction of the other risk factors

    Time frame: 1 year

    arterial hypertension inferior to 140/90 Hgmm; low density lipoprotein cholesterol inferior to 1g/l

  4. diabetes mellitus with HbA1C inferior to 7%

    Time frame: 1 year

  5. quality of life with mental and physical scores (SF-12)

    Time frame: 1 year

  6. patient's level of knowledge of the disease: number of correct answers to 19 questions

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Resicard

Other

Registry information

Official study title

A Network to Control Risk Factors After Acute Coronary Syndrome

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jun 16, 2006
Registry last updated
Apr 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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