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

26. Juni 2026 aktualisiert von: 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.

Studienübersicht

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

25000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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.
Zeitfenster: From enrollement to six months of follow-up.
From enrollement to six months of follow-up.

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. Februar 2027

Studienabschluss (Geschätzt)

1. August 2041

Studienanmeldedaten

Zuerst eingereicht

27. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juni 2026

Zuerst gepostet (Tatsächlich)

30. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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