NCT00337480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
504

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

June 14, 2006

Last Update Submit

April 12, 2013

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndromecardiovascular risk factorssmoking habitsobesitysedentary lifestyleoverweighteducationfollow up after hospitalization

Outcome Measures

Primary Outcomes (4)

  • nicotinic weaning

    1year

  • weight loss at least 5%

    1 year

  • waist reduction at least 4%

    1 year

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

    1 year

Secondary Outcomes (6)

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

    1 year

  • correction of each risk factor of primary outcome, individually

    1 year

  • correction of the other risk factors

    1 year

  • diabetes mellitus with HbA1C inferior to 7%

    1 year

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

    1 year

  • +1 more secondary outcomes

Study Arms (2)

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

Interventions

educationBEHAVIORAL

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

Also known as: House of Education, Structured network, health members
structured

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • lack of understanding or phrasing
  • refusal to sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinique la Roseraie

Aubervilliers, 93300, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hopital Saint Antoine

Paris, 75011, France

Location

Hopital Pitie Salpetriere

Paris, 75013, France

Location

Hopital Bichat

Paris, 75018, France

Location

Hopital Tenon

Paris, 75020, France

Location

Related Publications (1)

  • 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.

    PMID: 24126705DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeSmokingObesitySedentary BehaviorOverweight

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Ariel Cohen, Pr

    Hopital St Antoine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 14, 2006

First Posted

June 16, 2006

Study Start

July 1, 2006

Primary Completion

July 1, 2008

Study Completion

September 1, 2009

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations

FR(6)