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

26 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Studietype

Observationeel

Inschrijving (Geschat)

25000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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.
Tijdsspanne: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

1 augustus 2041

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

30 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

26 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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