- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Théo PEZEL, MD, PhD
- Telefonní číslo: +33 1 49 95 8224
- E-mail: theo.pezel@aphp.fr
Studijní záloha kontaktů
- Jméno: Julien HUDELO, MD
- E-mail: juhudelo@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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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.
Časové okno: From enrollement to six months of follow-up.
|
From enrollement to six months of follow-up.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion referred to cardiac computed tomography (CCT)
Časové okno: From enrollement to six months of follow-up.
|
From enrollement to six months of follow-up.
|
|
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Proportion referred to cardiovascular magnetic resonance (CMR)
Časové okno: From enrollement to six months of follow-up.
|
From enrollement to six months of follow-up.
|
|
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Proportion referred to stress tests.
Časové okno: 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
Časové okno: From enrollement to six months of follow-up.
|
From enrollement to six months of follow-up.
|
|
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Proportion with introduction of heart failure (HF) therapy
Časové okno: From enrollement to six months of follow-up.
|
From enrollement to six months of follow-up.
|
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Proportion with introduction of anti-platelet therapy
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: From enrollement to six months of follow-up.
|
From enrollement to six months of follow-up.
|
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Cost of care pathways initial and up to 2-5 years
Časové okno: 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
Časové okno: From enrollement to ten years of follow-up.
|
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
Časové okno: 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.
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F1 score of the artificial intelligence model for detecting cardiac involvement
Časové okno: 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
Časové okno: 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).
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Number of sick leave
Časové okno: From enrollement to five years of follow-up.
|
From enrollement to five years of follow-up.
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Five-year event-free survival
Časové okno: 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.
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Area under the precision-recall curve (PR-AUC) of the artificial intelligence model for detecting cardiac involvement
Časové okno: From enrollement to six months of follow-up.
|
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
Časové okno: From enrollement to six months of follow-up.
|
From enrollement to six months of follow-up.
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Duration of sick leave
Časové okno: 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.
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Cévní onemocnění
- Kardiovaskulární choroby
- Patologické procesy
- Srdeční choroba
- Nemoci dýchacích cest
- Plicní onemocnění
- Embolie a trombóza
- Embolie
- Ischémie myokardu
- Trombóza
- Patologické stavy, příznaky a symptomy
- Srdeční selhání
- Hypertenze
- Plicní embolie
- Žilní trombóza
- Akutní koronární syndrom
- Arytmie, srdeční
Další identifikační čísla studie
- APHP260122
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