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

NCT07178444 | Not Yet Recruiting

• 3 other identifiers: APHP2409522025-A00698-41PHRIP-23-0025
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 4

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:

• "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

Keywords

acute coronary syndrome; dyslipidemias; patient education; multidisciplinary care team; nurse practitioners

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• Proportion of patients reaching the LDL cholesterol target

  At enrollment then at the first month, 6th month and 12th month

• Proportion of patients reaching the LDL cholesterol target

  At enrollment then at the first month, 6th month and 12th month

• Changes in cardiovascular risk factors

  At enrollment then at the first month, 6th month and 12th month

• Physical Activity Score

  At enrollment then at the 6th month and 12th month

• Proportion of patients who participated in a cardiac rehabilitation program

  At 6th month and 12th month

Study Arms (2)

"Standard" care pathway

ACTIVE COMPARATOR

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

"New" care pathway

EXPERIMENTAL

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

Interventions

"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.

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

"New" care pathway

"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.

"Standard" care pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ;

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (4)

Centre Hospitalier Sud Francilien, Pôle Cardiologie

Corbeil-Essonnes, 91100, France

Location

Hopital Saint Joseph-Saint Luc, Cardiologie

Lyon, 69007, France

Location

CHU Montpellier - Hôpital Arnaud de Villeneuve, Cardiologie

Montpellier, 34295, France

Location

Hôpital Européen Georges Pompidou - AP-HP, Cardiologie

Paris, 74015, France

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Dyslipidemias

Interventions

Nutritionists; Pharmacists

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Melissa JOLY GOURJAULT

  Hôpital Européen Georges Pompidou - AP-HP

  PRINCIPAL INVESTIGATOR

• Thibaut CARUBA

  Hôpital européen Georges-Pompidou - AP-HP

  STUDY CHAIR

Central Study Contacts

Youcef SEKOUR

CONTACT

0033(0)156095823; youcef.sekour@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: September 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: 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).

Locations

FR (4)