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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00698-41 | Other Identifier | French National Agency for the Safety of Medicines and Health Products (ANSM) | |
| PHRIP-23-0025 | Other Identifier | French ministry of health, DGOS |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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According to the World Health Organization (WHO), cardiovascular diseases are the worldwide leading cause of death. For the French public health, cardiovascular diseases are the leading cause of death for the women and the second for men. Each year in France, approximately 120,000 acute coronary syndromes (ACS) occur, including 60,000 myocardial infarctions and more than 15,000 deaths. To prevent or reverse this process, the WHO recommends early detection of the diseases and reduce behavioral and cardiovascular risk factors.
For the patient, the European Society of Cardiology (ESC) recommends the implementation of secondary prevention measures, the lifestyle modifications and the encouragement to become an actor in the management of his health. The first year, the medical follow-up is recommended at 3, 6 and 12 months.
Since 2019, in order to reduce the impact of LDL cholesterol, the ESC has recommended that LDL cholesterol levels be lower than 0.55 g/L accompanied by a reduction of at least 50% from their initial value. In 2023, it clarified this recommendation by recommending a laboratory reassessment within 4-6 weeks after hospital discharge.
The application of these recommendations comes up against the difficulties of real life:
Given the difficulties in implementing the recommendations, investigators believe it is essential to rethink the care pathway for post-ACS patients.
The investigator's hypothesis is that, in addition to the standard pathway, a care offering access to other healthcare professionals (advanced practice nurse, dietitian, pharmacist) should increase the proportion of patients achieving LDL cholesterol targets (LDL cholesterol < 0.55 g/L and a 50% reduction in this level compared to the baseline value) at 12 months. LDL cholesterol was selected as the endpoint because it has been proven that a reduction in LDL cholesterol corresponds to a 22% reduction in cardiovascular events.
To test this hypothesis, the investigators designed a multicenter controlled and randomized trial with two parallel arms:
In order for the conclusions of this protocol to reflect French practices, it is planned to include 230 people who have presented with acute coronary syndrome in four healthcare facilities in France (both in Paris and outside Paris).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Standard" care pathway | Active Comparator | Control arm:
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| "New" care pathway | Experimental | Intervention arm: In addition to the Standard care pathway:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "New" care pathway | Behavioral | Initially, the patient will have an interdisciplinary consultation aimed at identifying personalized goals for the patient and providing educational/preventive care using tools that will be provided to all centers. This consultation will bring together a cardiologist, an advanced practice nurse (APN), a dietitian and a pharmacist. This consultation will take place approximately 4 weeks after the hospitalization for acute coronary syndrome (ACS). Secondly, the patient will have 3 follow-up consultations with the APN (at 3, 6 and 12 months after discharge from hospitalization for an ACS). During these consultations, the APN will perform a clinical assessment, a personalized educational support, a coaching based on the patient's personalized goals, an adjustment of therapies and, depending on needs, referral to other health professionals. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients reaching the LDL cholesterol target | The target is definde as LDL cholesterol level <0.55 g/L and >50% reduction from baseline | At enrollment then at the 12th month |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients reaching the LDL cholesterol target | The target for this outcome is defined as LDL cholesterol <0.55 g/L | At enrollment then at the first month, 6th month and 12th month |
| Proportion of patients reaching the LDL cholesterol target |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youcef SEKOUR | Contact | 0033(0)156095823 | youcef.sekour@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Melissa JOLY GOURJAULT | Hôpital Européen Georges Pompidou - AP-HP | Principal Investigator |
| Thibaut CARUBA | Hôpital européen Georges-Pompidou - AP-HP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien, Pôle Cardiologie | Corbeil-Essonnes | 91100 | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
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| "Standard" care pathway | Other | The French National Health Authority recommends two medical visits (at 6 and 12 month) and, if necessary, a third one (between the first and third month post-ACS) for the monitoring of the left ventricular. - The European Society of Cardiology recommends a reassessment of the lipid profile within 4-6 weeks post-ACS. |
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The target for this outcome is defined as LDL cholesterol level reduction > 50% compared to baseline value |
| At enrollment then at the first month, 6th month and 12th month |
| Changes in cardiovascular risk factors | This outcome aims to assess changes in the patient's overall cardiovascular risk profile throughout the study. Multiple parameters will be evaluated to capture a comprehensive picture of the modifications in cardiovascular risk factors presented by each patient. The parametrers will be:
| At enrollment then at the first month, 6th month and 12th month |
| Physical Activity Score | Total score on the "Ricci and Gagnon Self-Assessment of Physical Activity" Questionnaire (activity self-assessment questionnaire). The minimum value is 9 The maximum value is 45 Under 18: inactive Between 18 and 35: active Over 35: very active | At enrollment then at the 6th month and 12th month |
| Proportion of patients who participated in a cardiac rehabilitation program | This outcome aims to assess the proportion of patients who engage in a cardiac rehabilitation program following an acute coronary syndrome | At 6th month and 12th month |
| Proportion of patients consuming toxic substances and their quantity measured | The substances involved are: alcohol, tobacco, and drugs | At enrollment then at the 6th month and 12th month |
| Quality of life score | Measured using the EQ-5D-5L Questionnaire (European quality of life 5 dimensions 5 levels questionnaire) The (EQ-5D-5L) questionnaire provides two types of scores. The first is an index scored derived from five health dimensions (mobility, self-care, actual activities, pain/discomfort, and anxiety/depression) converted into a single value ranged from 0 (representing health states considered worse than death) to 1(representing perfect health). The second is the EQ Visual Analogue Scale (EQ-VAS), a self-rated health measure ranging from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine") representing self-rated health. | At enrollment then at the 6th month and 12th month |
| Therapeutic Compliance Score | Measured using FREEDOM questionnaire (FREE Detection non Observance Medication) The FREEDOM questionnaire includes 11 items rated on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree". The questionnaire responses will be used qualitatively, without calculation of a numerical total score, to classify patients into categories of medication adherence (low, moderate, high). | At enrollment then at the 6th month and 12th month |
| List of lipid-lowering treatments taken by patients | This outcome aims to describe the lipid-lowering therapy prescribed to each patient, as well as any modifications made during follow-up. This outcome focuses solely on documenting which lipid-lowering treatments patients are receiving and does not involve any comparison or evaluation of the effectiveness or safety of different lipid-lowering therapie | At enrollment then at the first month, 6th month and 12th month |
| Number of medical (cardiologist or general practitioner) and/or paramedical (dietician, etc.) consultations | At 6th month and 12th month |
| Mortality rate and the reasons | At 6th month and 12th month |
| Rehospitalization rates and the reasons | At 6th month and 12th month |
| Rate of cardiovascular events | At 12th month |
| Estimation of cost per QALY gained and cost per serious cardiac event avoided | QALY: quality-adjusted life year | At 12th month |
| Professional satisfaction rate by using a satisfaction scale from 0 to 10 | Satisfaction with the care provided to the patient under the EDUSCA protocol | At 12th month |
| Hopital Saint Joseph-Saint Luc, Cardiologie | Lyon | 69007 | France |
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| CHU Montpellier - Hôpital Arnaud de Villeneuve, Cardiologie | Montpellier | 34295 | France |
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| Hôpital Européen Georges Pompidou - AP-HP, Cardiologie | Paris | 74015 | France |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D064686 | Nutritionists |
| D010595 | Pharmacists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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