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

NCT07675434 | Not Yet Recruiting

• 1 other identifier: APHP260122
• Study Type: observational
• Target: 25,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Coronary Syndromes; Heart Failure; Pulmonary Embolism, Deep Vein Thrombosis; HTN-Hypertension; Arrhythmia

Keywords

Cardiovascular emergencies; Multimodality Imaging; Acute care; Prospective cohort; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• Patient unable to provide informed consent
• Patient not affiliated to French social security

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• MIRACL.ai: collaborator
• INSERM UMR-S 942 MASCOT: collaborator

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure; Pulmonary Embolism; Venous Thrombosis; Hypertension; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Thrombosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Théo PEZEL, MD, PhD

CONTACT

+33 1 49 95 8224; theo.pezel@aphp.fr

Julien HUDELO, MD

CONTACT

juhudelo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 30, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2041
• Last Updated: June 30, 2026

Record last verified: 2026-06