AzTrials
AzTrials

Acute Coronary SyndromesCESARNCT07675434

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

An observational study of Acute Coronary Syndromes and Heart Failure, run by Assistance Publique - Hôpitaux de Paris.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
25,000 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 1 Aug 2041
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Théo PEZEL, MD, PhD contact

+33 1 49 95 8224

theo.pezel@aphp.fr

Julien HUDELO, MD contact

juhudelo@gmail.com

About this study

Official title: 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.

Keywords
Cardiovascular emergencies, Multimodality Imaging, Acute care, Prospective cohort, Biomarkers
Medical subject headings
Acute Coronary Syndrome, Heart Failure, Pulmonary Embolism, Venous Thrombosis, Hypertension, Arrhythmias, Cardiac

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollement to six months of follow-up.

Secondary outcomes (24)

  1. Proportion referred to cardiac computed tomography (CCT)

    Measured: From enrollement to six months of follow-up.

  2. Proportion referred to cardiovascular magnetic resonance (CMR)

    Measured: From enrollement to six months of follow-up.

  3. Proportion referred to stress tests.

    Measured: From enrollement to six months of follow-up.

  4. Proportion referred to Holter monitoring or implantable loop recorders

    Measured: From enrollement to six months of follow-up.

  5. Proportion with introduction of heart failure (HF) therapy

    Measured: From enrollement to six months of follow-up.

  6. Proportion with introduction of anti-platelet therapy

    Measured: From enrollement to six months of follow-up.

  7. Proportion with introduction of anti-coagulant therapy

    Measured: From enrollement to six months of follow-up.

  8. Proportion referred to percutaneous coronary intervention (PCI)

    Measured: From enrollement to six months of follow-up.

  9. Proportion referred to cardiac surgery

    Measured: From enrollement to six months of follow-up.

  10. Proportion referred to electrical cardioversion

    Measured: From enrollement to six months of follow-up.

  11. Proportion referred to catheter ablation

    Measured: From enrollement to six months of follow-up.

  12. Proportion referred to pacemaker implantation

    Measured: From enrollement to six months of follow-up.

  13. Proportion referred to defibrillator implantation

    Measured: From enrollement to six months of follow-up.

  14. Diagnostic performance of each initial parameter with: sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve.

    Measured: From enrollement to six months of follow-up.

  15. Cost of care pathways initial and up to 2-5 years

    Measured: From enrollement to five years of follow-up.

  16. Prognostic value of baseline features to predict medical events annually up to 10 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...)
    13. Electrophysiological studies (catheter ablation, pacemaker / defibrillator implantation...)

    Measured: From enrollement to ten years of follow-up.

  17. 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.

    Measured: From enrollement to five years of follow-up.

  18. F1 score of the artificial intelligence model for detecting cardiac involvement

    Measured: From enrollement to six months of follow-up.

  19. 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

    Measured: At enrollement (D0).

  20. Number of sick leave

    Measured: From enrollement to five years of follow-up.

  21. 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.

    Measured: From enrollement to five years of follow-up.

  22. Area under the precision-recall curve (PR-AUC) of the artificial intelligence model for detecting cardiac involvement

    Measured: From enrollement to six months of follow-up.

  23. Area under the receiver operating characteristic curve (ROC-AUC) of the artificial intelligence model for detecting cardiac involvement

    Measured: From enrollement to six months of follow-up.

  24. Duration of sick leave

    Cumulative duration of sick leave during follow-up in days.

    Measured: From enrollement to five years of follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Aug 2041 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07675434
Sponsor's protocol ID
APHP260122
Acronym
CESAR
Status last verified
Jun 2026
First submitted
27 May 2026
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndromes and Heart Failure, run by Assistance Publique - Hôpitaux de Paris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Théo PEZEL, MD, PhD (+33 1 49 95 8224, theo.pezel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: From enrollement to six months of follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07675434.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in