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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Théo PEZEL, MD, PhD
- Numero di telefono: +33 1 49 95 8224
- Email: theo.pezel@aphp.fr
Backup dei contatti dello studio
- Nome: Julien HUDELO, MD
- Email: juhudelo@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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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.
Lasso di tempo: From enrollement to six months of follow-up.
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From enrollement to six months of follow-up.
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion referred to cardiac computed tomography (CCT)
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Malattia cardiovascolare
- Processi patologici
- Malattie cardiache
- Malattie delle vie respiratorie
- Malattie polmonari
- Embolia e Trombosi
- Embolia
- Ischemia miocardica
- Trombosi
- Condizioni patologiche, segni e sintomi
- Arresto cardiaco
- Ipertensione
- Embolia polmonare
- Trombosi venosa
- Sindrome coronarica acuta
- Aritmie, cardiache
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- APHP260122
Informazioni su farmaci e dispositivi, documenti di studio
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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