- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07675434
Prospective Cohort of Acute Cardiology Referrals in an Ambulatory Day-Hospital Setting (CESAR)
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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Théo PEZEL, MD, PhD
- Número de teléfono: +33 1 49 95 8224
- Correo electrónico: theo.pezel@aphp.fr
Copia de seguridad de contactos de estudio
- Nombre: Julien HUDELO, MD
- Correo electrónico: juhudelo@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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.
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion referred to cardiac computed tomography (CCT)
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion referred to cardiovascular magnetic resonance (CMR)
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion referred to stress tests.
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion referred to Holter monitoring or implantable loop recorders
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion with introduction of heart failure (HF) therapy
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion with introduction of anti-platelet therapy
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion with introduction of anti-coagulant therapy
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion referred to percutaneous coronary intervention (PCI)
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion referred to cardiac surgery
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion referred to electrical cardioversion
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion referred to catheter ablation
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion referred to pacemaker implantation
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Proportion referred to defibrillator implantation
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Diagnostic performance of each initial parameter with: sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve.
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Cost of care pathways initial and up to 2-5 years
Periodo de tiempo: From enrollement to five years of follow-up.
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From enrollement to five years of follow-up.
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Prognostic value of baseline features to predict medical events annually up to 10 years of follow-up
Periodo de tiempo: From enrollement to ten years of follow-up.
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The occurrence of:
n. Electrophysiological studies (catheter ablation, pacemaker / defibrillator implantation...) |
From enrollement to ten years of follow-up.
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Cost-effectiveness of the CESAR care pathway
Periodo de tiempo: From enrollement to five years of follow-up.
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Cost-effectiveness of the CESAR care pathway compared with a propensity score-matched control population extracted from the French national health claims database.
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From enrollement to five years of follow-up.
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F1 score of the artificial intelligence model for detecting cardiac involvement
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Prognostic value of voice-derived acoustic and speech parameters
Periodo de tiempo: At enrollement (D0).
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The occurrence of: a. All-cause mortality b.
Cardiovascular mortality c.
Sudden cardiac death d.
Hospitalization for any cardiovascular reason and duration of hospitalization
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At enrollement (D0).
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Number of sick leave
Periodo de tiempo: From enrollement to five years of follow-up.
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From enrollement to five years of follow-up.
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Five-year event-free survival
Periodo de tiempo: From enrollement to five years of follow-up.
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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.
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From enrollement to five years of follow-up.
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Area under the precision-recall curve (PR-AUC) of the artificial intelligence model for detecting cardiac involvement
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Area under the receiver operating characteristic curve (ROC-AUC) of the artificial intelligence model for detecting cardiac involvement
Periodo de tiempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Duration of sick leave
Periodo de tiempo: From enrollement to five years of follow-up.
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Cumulative duration of sick leave during follow-up in days.
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From enrollement to five years of follow-up.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades cardíacas
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Embolia y Trombosis
- Embolia
- Isquemia miocardica
- Trombosis
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia cardiaca
- Hipertensión
- Embolia pulmonar
- Trombosis venosa
- El síndrome coronario agudo
- Arritmias Cardiacas
Otros números de identificación del estudio
- APHP260122
Información sobre medicamentos y dispositivos, documentos del estudio
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