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

2026年6月26日 更新者: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.

研究概览

研究类型

观察性的

注册 (估计的)

25000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Théo PEZEL, MD, PhD
  • 电话号码:+33 1 49 95 8224
  • 邮箱:theo.pezel@aphp.fr

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
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.
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.

次要结果测量

结果测量
措施说明
大体时间
Proportion referred to cardiac computed tomography (CCT)
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to cardiovascular magnetic resonance (CMR)
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to stress tests.
大体时间: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
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion with introduction of heart failure (HF) therapy
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion with introduction of anti-platelet therapy
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion with introduction of anti-coagulant therapy
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to percutaneous coronary intervention (PCI)
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to cardiac surgery
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to electrical cardioversion
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to catheter ablation
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to pacemaker implantation
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Proportion referred to defibrillator implantation
大体时间: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.
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:From enrollement to five years of follow-up.
From enrollement to five years of follow-up.
Five-year event-free survival
大体时间: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
大体时间: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
大体时间:From enrollement to six months of follow-up.
From enrollement to six months of follow-up.
Duration of sick leave
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2041年8月1日

研究注册日期

首次提交

2026年5月27日

首先提交符合 QC 标准的

2026年6月26日

首次发布 (实际的)

2026年6月30日

研究记录更新

最后更新发布 (实际的)

2026年6月30日

上次提交的符合 QC 标准的更新

2026年6月26日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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