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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Arrhythmia; Acute Coronary Syndromes; Pulmonary Embolism, Deep Vein Thrombosis; HTN-Hypertension

• Study Type: Observational
• Enrollment (Estimated): 25000

Contacts and Locations

• Study Contact: Name: Théo PEZEL, MD, PhD; Phone Number: +33 1 49 95 8224; Email: theo.pezel@aphp.fr
• Study Contact Backup: Name: Julien HUDELO, MD; Email: juhudelo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	From enrollement to six months of follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion referred to cardiac computed tomography (CCT)		From enrollement to six months of follow-up.
Proportion referred to cardiovascular magnetic resonance (CMR)		From enrollement to six months of follow-up.
Proportion referred to stress tests.		From enrollement to six months of follow-up.
Proportion referred to Holter monitoring or implantable loop recorders		From enrollement to six months of follow-up.
Proportion with introduction of heart failure (HF) therapy		From enrollement to six months of follow-up.
Proportion with introduction of anti-platelet therapy		From enrollement to six months of follow-up.
Proportion with introduction of anti-coagulant therapy		From enrollement to six months of follow-up.
Proportion referred to percutaneous coronary intervention (PCI)		From enrollement to six months of follow-up.
Proportion referred to cardiac surgery		From enrollement to six months of follow-up.
Proportion referred to electrical cardioversion		From enrollement to six months of follow-up.
Proportion referred to catheter ablation		From enrollement to six months of follow-up.
Proportion referred to pacemaker implantation		From enrollement to six months of follow-up.
Proportion referred to defibrillator implantation		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.		From enrollement to six months of follow-up.
Cost of care pathways initial and up to 2-5 years		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	The occurrence of: All-cause mortality; Cardiovascular mortality; Sudden cardiac death; Hospitalization for any cardiovascular reason and duration of hospitalization; Hospitalization for HF; Myocardial infarction (MI); Stroke; Incident atrial fibrillation (AF); Cardiac syncope; Incident ventricular arrhythmia; Cardiac surgery; 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	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		From enrollement to six months of follow-up.
Prognostic value of voice-derived acoustic and speech parameters	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		From enrollement to five years of follow-up.
Five-year event-free survival	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		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		From enrollement to six months of follow-up.
Duration of sick leave	Cumulative duration of sick leave during follow-up in days.	From enrollement to five years of follow-up.

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: INSERM UMR-S 942 MASCOT; MIRACL.ai

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2041

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Biomarkers; Prospective cohort; Acute care; Cardiovascular emergencies; Multimodality Imaging
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Myocardial Ischemia; Thrombosis; Pathological Conditions, Signs and Symptoms; Heart Failure; Hypertension; Pulmonary Embolism; Venous Thrombosis; Acute Coronary Syndrome; Arrhythmias, Cardiac
• Other Study ID Numbers: APHP260122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No