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

Acute Coronary Syndrome Clinical Trial

Official title:

A Network to Control Risk Factors After Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337480
• Other study ID #: Resicard Prevention
• Status: Completed
• Phase: N/A
• First received: June 14, 2006
• Last updated: April 12, 2013
• Start date: July 2006
• Est. completion date: September 2009

Study information

• Verified date: April 2013
• Source: Resicard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: September 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Clinique la Roseraie	Aubervilliers
France	Hopital Bichat	Paris
France	Hopital Lariboisiere	Paris
France	Hopital Pitie Salpetriere	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Resicard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nicotinic weaning		1year	No
Primary	weight loss at least 5%		1 year	No
Primary	waist reduction at least 4%		1 year	No
Primary	physical activity at least 30 minute per day (3h per week)		1 year	No
Secondary	correction of nicotinic addiction, overweigh and lack of physical activity all together		1 year	No
Secondary	correction of each risk factor of primary outcome, individually		1 year	No
Secondary	correction of the other risk factors	arterial hypertension inferior to 140/90 Hgmm; low density lipoprotein cholesterol inferior to 1g/l	1 year	No
Secondary	diabetes mellitus with HbA1C inferior to 7%		1 year	No
Secondary	quality of life with mental and physical scores (SF-12)		1 year	No
Secondary	patient's level of knowledge of the disease: number of correct answers to 19 questions		1 year	No