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Prospective Cohort of Acute Cardiology Referrals in an Ambulatory Day-Hospital Setting (CESAR)

26 juin 2026 mis à jour par: Assistance Publique - Hôpitaux de Paris

CESAR Study: Prospective Cohort of Consecutive Patients Undergoing Cardiologic Evaluation in a Specialized Ambulatory Referral Unit

Suspected acute or subacute cardiovascular diseases-including chest pain, dyspnea, and palpitations-are among the most common reasons for unscheduled emergency department visits and pre-hospital referrals. Despite this high clinical burden, the diagnostic yield is often limited, with a frequent mismatch between initial clinical suspicion and final diagnosis, contributing to substantial healthcare utilization and hospitalization rates. Current evidence is largely focused on specific conditions such as acute coronary syndromes, heart failure, arrhythmias, or pulmonary embolism, and rarely integrates the full spectrum of clinical, biological, and imaging data obtained during initial evaluation.

To address this gap, we will establish a prospective cohort of all consecutive patients referred to the ambulatory day-hospital cardiology unit at Lariboisière University Hospital. This unit acts as a specialized downstream referral structure within the emergency care pathway, receiving patients after triage by emergency physicians, pre-hospital regulation services (SAMU), mobile intensive care units (SMUR), or emergency departments. Although it does not capture all suspected cardiovascular emergencies, it represents a selected real-world population deemed to require specialized acute cardiology assessment.

The primary objective is to assess the frequency of cardiac conditions diagnosed in this cohort. Secondary objectives include characterization of patient profiles and diagnostic pathways; evaluation of the diagnostic and prognostic performance of clinical, biological, imaging, and multimodal parameters using final Heart Team diagnosis as reference; analysis of prior health history and healthcare utilization; and assessment of the medico-economic burden of suspected acute cardiovascular disease. The study will further support the development of a dedicated biobank and the validation of next-generation biomarkers, including AI-driven and voice-based markers, as well as decision-support algorithms for binary classification of cardiac involvement. Through integration of multimodal data and linkage with national health records, this approach aims to improve diagnostic accuracy, risk stratification, and understanding of the healthcare impact of acute cardiovascular presentations in a real-world setting.

Aperçu de l'étude

Type d'étude

Observationnel

Inscription (Estimé)

25000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Théo PEZEL, MD, PhD
  • Numéro de téléphone: +33 1 49 95 8224
  • E-mail: theo.pezel@aphp.fr

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Consecutive patients referred to ambulatory day-hospital unit for suspicion of acute or sub-acute cardiovascular disease at the Cardiology Department of Lariboisière University Hospital.

La description

Inclusion Criteria:

- The study will include all consecutive patients referred to ambulatory day-hospital unit for suspicion of acute or sub-acute cardiovascular disease at the Cardiology Department of Lariboisière University Hospital.

Exclusion Criteria:

  • Patient unable to provide informed consent
  • Patient not affiliated to French social security

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Proportion of patients with confirmed cardiovascular diagnosis among consecutive patients consulting for suspicion of acute or sub-acute cardiovascular disease at the ambulatory day-hospital unit.
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion referred to cardiac computed tomography (CCT)
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to cardiovascular magnetic resonance (CMR)
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to stress tests.
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to Holter monitoring or implantable loop recorders
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion with introduction of heart failure (HF) therapy
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion with introduction of anti-platelet therapy
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion with introduction of anti-coagulant therapy
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to percutaneous coronary intervention (PCI)
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to cardiac surgery
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to electrical cardioversion
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to catheter ablation
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to pacemaker implantation
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to defibrillator implantation
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Diagnostic performance of each initial parameter with: sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve.
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Cost of care pathways initial and up to 2-5 years
Délai: From enrollement to five years of follow-up.
From enrollement to five years of follow-up.
Prognostic value of baseline features to predict medical events annually up to 10 years of follow-up
Délai: From enrollement to ten years of follow-up.

The occurrence of:

  1. All-cause mortality
  2. Cardiovascular mortality
  3. Sudden cardiac death
  4. Hospitalization for any cardiovascular reason and duration of hospitalization
  5. Hospitalization for HF
  6. Myocardial infarction (MI)
  7. Stroke
  8. Incident atrial fibrillation (AF)
  9. Cardiac syncope
  10. Incident ventricular arrhythmia
  11. Cardiac surgery
  12. Coronary revascularization including PCI and coronary artery bypass grafting (CABG) m. Valvular percutaneous intervention (TAVI, TMVI, mitral or tricuspid clips...)

n. Electrophysiological studies (catheter ablation, pacemaker / defibrillator implantation...)

From enrollement to ten years of follow-up.
Cost-effectiveness of the CESAR care pathway
Délai: From enrollement to five years of follow-up.
Cost-effectiveness of the CESAR care pathway compared with a propensity score-matched control population extracted from the French national health claims database.
From enrollement to five years of follow-up.
F1 score of the artificial intelligence model for detecting cardiac involvement
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Prognostic value of voice-derived acoustic and speech parameters
Délai: At enrollement (D0).
The occurrence of: a. All-cause mortality b. Cardiovascular mortality c. Sudden cardiac death d. Hospitalization for any cardiovascular reason and duration of hospitalization
At enrollement (D0).
Number of sick leave
Délai: From enrollement to five years of follow-up.
From enrollement to five years of follow-up.
Five-year event-free survival
Délai: From enrollement to five years of follow-up.
Event-free survival in patients managed through the CESAR care pathway compared with a propensity score-matched control population extracted from the French national health claims database.
From enrollement to five years of follow-up.
Area under the precision-recall curve (PR-AUC) of the artificial intelligence model for detecting cardiac involvement
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Area under the receiver operating characteristic curve (ROC-AUC) of the artificial intelligence model for detecting cardiac involvement
Délai: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Duration of sick leave
Délai: From enrollement to five years of follow-up.
Cumulative duration of sick leave during follow-up in days.
From enrollement to five years of follow-up.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 février 2027

Achèvement de l'étude (Estimé)

1 août 2041

Dates d'inscription aux études

Première soumission

27 mai 2026

Première soumission répondant aux critères de contrôle qualité

26 juin 2026

Première publication (Réel)

30 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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