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

26 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Tipo de estudo

Observacional

Inscrição (Estimado)

25000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Théo PEZEL, MD, PhD
  • Número de telefone: +33 1 49 95 8224
  • E-mail: theo.pezel@aphp.fr

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
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.
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion referred to cardiac computed tomography (CCT)
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to cardiovascular magnetic resonance (CMR)
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to stress tests.
Prazo: 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
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion with introduction of heart failure (HF) therapy
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion with introduction of anti-platelet therapy
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion with introduction of anti-coagulant therapy
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to percutaneous coronary intervention (PCI)
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to cardiac surgery
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to electrical cardioversion
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to catheter ablation
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to pacemaker implantation
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to defibrillator implantation
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: From enrollement to five years of follow-up.
From enrollement to five years of follow-up.
Five-year event-free survival
Prazo: 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
Prazo: 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
Prazo: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Duration of sick leave
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de fevereiro de 2027

Conclusão do estudo (Estimado)

1 de agosto de 2041

Datas de inscrição no estudo

Enviado pela primeira vez

27 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de junho de 2026

Primeira postagem (Real)

30 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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