Evaluation of the Effectiveness of an Interdisciplinary Intervention After Acute Coronary Syndrome on Low-Density Lipoprotein Cholesterol Levels

NCT ID: NCT07178444

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-11-30

Brief Summary

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:

1. The increase in the number of elderly people and people with one or more chronic diseases;

2. In France, the significant regional disparities in the number of physicians;

3. In 2022, six months after hospitalization for an ACS, only 21.6% of French patients had benefited from a cardiac rehabilitation program;

4. Within 12 months of acute coronary syndrome, only 20% to 40% of patients achieved the LDL cholesterol targets recommended by the ESC.

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:

• "Routine Cares" arm: Each center will program cares as usual and will schedule patient follow-up according to their wishes (cardiac rehabilitation, visits to the general practitioner and/or cardiologist).
• "Intervention" arm: In addition to routine care as described above, the patient will receive an interdisciplinary consultation one month after hospital discharge and three consultations with the IPA (3, 6, and 12 months).

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).

Conditions

Acute Coronary Syndromes (ACS); Acute Coronary Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

"Standard" care pathway

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.

Group Type: ACTIVE_COMPARATOR

"Standard" care pathway

Intervention Type: 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.

"New" 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

Group Type: EXPERIMENTAL

"New" care pathway

Intervention Type: 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.

Interventions

"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.

Intervention Type: BEHAVIORAL

"Standard" 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.

Intervention Type: OTHER

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• Adult patients hospitalized for ACS (ST+ or ST-), affiliated with a social security scheme, able to understand the protocol and having signed the study consent.

Exclusion Criteria

• Patients with a complication of the ACS (mechanical complication, cardiogenic shock, very severe left ventricular dysfunction, presence of an intraventricular thrombus, complex ventricular rhythm disorder) ;
• Proven cognitive impairment or decompensated psychological/psychiatric disorder ;
• Any progressive inflammatory and/or infectious condition ;
• Any orthopedic problem precluding the physical activity ;
• Current participation in any clinical research project aimed at reducing LDL cholesterol levels ;
• Pregnant or breastfeeding woman ;
• Patient receiving state medical assistance ;
• Patient under guardianship or curatorship, or any other legal protection measure ;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa JOLY GOURJAULT

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Georges Pompidou - AP-HP

Thibaut CARUBA

Role: STUDY_CHAIR

Hôpital européen Georges-Pompidou - AP-HP

Locations

Centre Hospitalier Sud Francilien, Pôle Cardiologie

Corbeil-Essonnes, , France

Hopital Saint Joseph-Saint Luc, Cardiologie

Lyon, , France

CHU Montpellier - Hôpital Arnaud de Villeneuve, Cardiologie

Montpellier, , France

Hôpital Européen Georges Pompidou - AP-HP, Cardiologie

Paris, , France

Countries

France

Central Contacts

Youcef SEKOUR

Role: CONTACT

youcef.sekour@aphp.fr

0033(0)156095823

Facility Contacts

Müge TABAN

Role: primary

muge.taban@chsf.fr

0033(0)161693701

Bochra RIAHI

Role: primary

briahi@saintjosephsaintluc.fr

0033(4)78618682

Nawel AOUNI

Role: primary

n-aouni@chu-montpellier.fr

033(4)67333203

Mélissa JOLY GOURJAULT

Role: primary

melissa.gourjault@aphp.fr

0033(0)156093001

Other Identifiers

2025-A00698-41

Identifier Type: OTHER

Identifier Source: secondary_id

PHRIP-23-0025

Identifier Type: OTHER

Identifier Source: secondary_id

APHP240952

Identifier Type: -

Identifier Source: org_study_id