Acute Coronary SyndromeNCT00337480
Study of the Efficiency of Education About Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome
A study testing education in people with Acute Coronary Syndrome, run by Resicard at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 6 sitesFrance
- Study dates
- Jul 2006to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- lack of understanding or phrasing
- refusal to sign the consent form
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Clinique la Roseraie
Aubervilliers, 93300
Hopital Lariboisiere
Paris, 75010
Hopital Saint Antoine
Paris, 75011
Hopital Pitie Salpetriere
Paris, 75013
Hopital Bichat
Paris, 75018
Hopital Tenon
Paris, 75020
About this study
Official title: A Network to Control Risk Factors After 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.
Read the detailed description
- 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- education
- Keywords
- acute coronary syndrome, cardiovascular risk factors, smoking habits, obesity, sedentary lifestyle, overweight, education, follow up after hospitalization
- Medical subject headings
- Acute Coronary Syndrome, Smoking, Obesity, Sedentary Behavior, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
Also called House of Education, Structured network, health members
education of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
nicotinic weaning
Measured: 1year
weight loss at least 5%
Measured: 1 year
waist reduction at least 4%
Measured: 1 year
physical activity at least 30 minute per day (3h per week)
Measured: 1 year
Secondary outcomes (6)
correction of nicotinic addiction, overweigh and lack of physical activity all together
Measured: 1 year
correction of each risk factor of primary outcome, individually
Measured: 1 year
correction of the other risk factors
arterial hypertension inferior to 140/90 Hgmm; low density lipoprotein cholesterol inferior to 1g/l
Measured: 1 year
diabetes mellitus with HbA1C inferior to 7%
Measured: 1 year
quality of life with mental and physical scores (SF-12)
Measured: 1 year
patient's level of knowledge of the disease: number of correct answers to 19 questions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startJul 2006
- Primary completionJul 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resicard
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Ariel Cohen, Resicard
- Investigators
- Ariel Cohen, Pr, Principal investigator, Hopital St Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337480
- Sponsor's protocol ID
- Resicard Prevention
- Status last verified
- Apr 2013
- First submitted
- 14 Jun 2006
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24126705
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Network to Control Risk Factors After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT00337480
- Acronym / sponsor ID
- Resicard Prevention
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, cardiovascular risk factors, smoking habits, obesity, sedentary lifestyle, overweight, education, follow up after hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- ResicardUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional | No intervention | –This arm is the conventional way of taking care of patients after an acute coronary syndrome |
| structured | Active comparator | Behavioral: educationThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- lack of understanding or phrasing
- refusal to sign the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educationAlso: House of Education, Structured network, health memberseducation of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity | Behavioural | structured |
Primary outcome
nicotinic weaning
Time frame: 1year
weight loss at least 5%
Time frame: 1 year
waist reduction at least 4%
Time frame: 1 year
physical activity at least 30 minute per day (3h per week)
Time frame: 1 year
6 secondary outcomes
correction of nicotinic addiction, overweigh and lack of physical activity all together
Time frame: 1 year
correction of each risk factor of primary outcome, individually
Time frame: 1 year
correction of the other risk factors
Time frame: 1 year
diabetes mellitus with HbA1C inferior to 7%
Time frame: 1 year
quality of life with mental and physical scores (SF-12)
Time frame: 1 year
patient's level of knowledge of the disease: number of correct answers to 19 questions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
- Derived from this study: PubMed 24126705Cohen 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.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Cohen, Pr principal investigator
Hopital St Antoine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Acute Coronary Syndrome, run by Resicard at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nicotinic weaning (time frame: 1year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00337480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.