An interventional study of "New" care pathway and "Standard" care pathway in Acute Coronary Syndromes (ACS) and Acute Coronary Syndromes, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention
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).
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 230 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Control arm: * 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.
Other: "Standard" care pathway
Intervention arm: In addition to the Standard care pathway: * One interdisciplinary consultation approximately 4 weeks post-ACS * Three consultations with the advanced practice nurse at approximately 3 months, 6 months and 12 months post-ACS
Behavioral: "New" care pathway
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.
Also known as: Interdisciplinaire consultation, Identifying personalized goals, Educational/preventive care, Advanced practice nurse, Dietitian, Pharmacist, Acute coronary syndrome, Follow-up consultations with an advanced practice nurse, Coaching, Adjustement of therapies, Coordination of the care pathway
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.
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
Time frame: At enrollment then at the 12th month
Proportion of patients reaching the LDL cholesterol target
The target for this outcome is defined as LDL cholesterol \<0.55 g/L
Time frame: At enrollment then at the first month, 6th month and 12th month
Proportion of patients reaching the LDL cholesterol target
The target for this outcome is defined as LDL cholesterol level reduction \> 50% compared to baseline value
Time frame: 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: * Dyslipidemia: Proportion of patients achieving the LDL cholesterol target set by the European Society of Cardiology (\<0.55 g/L and \>50% reduction from baseline) * Hypertension: Proportion of patients achieving a systolic blood pressure \< 140 mmHg and a diastolic blood pressure \< 90 mmHg * Percentage of patients with controlled type 2 diabetes (for a diabetic patient, HbA1c target \<7%) * BMI
Time frame: 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
Time frame: 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
Time frame: At 6th month and 12th month
Proportion of patients consuming toxic substances and their quantity measured
The substances involved are: alcohol, tobacco, and drugs
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: At 6th month and 12th month
Mortality rate and the reasons
Time frame: At 6th month and 12th month
Rehospitalization rates and the reasons
Time frame: At 6th month and 12th month
Rate of cardiovascular events
Time frame: At 12th month
Estimation of cost per QALY gained and cost per serious cardiac event avoided
QALY: quality-adjusted life year
Time frame: 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
Time frame: At 12th month
Plan to share: Yes — Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Supporting information: Study protocol, Icf
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