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Набор скоро начнётся NCT07675434

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Acute Coronary Syndromes, Heart Failure, Pulmonary Embolism, Deep Vein Thrombosis, HTN-Hypertension. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

CESAR Study: Prospective Cohort of Consecutive Patients Undergoing Cardiologic Evaluation in a Specialized Ambulatory Referral Unit

Обзор

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.

Первичные конечные точки

  • 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. [Срок оценки: From enrollement to six months of follow-up.]
Вторичные конечные точки (12)
  • Proportion referred to cardiac computed tomography (CCT) [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion referred to cardiovascular magnetic resonance (CMR) [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion referred to stress tests. [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion referred to Holter monitoring or implantable loop recorders [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion with introduction of heart failure (HF) therapy [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion with introduction of anti-platelet therapy [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion with introduction of anti-coagulant therapy [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion referred to percutaneous coronary intervention (PCI) [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion referred to cardiac surgery [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion referred to electrical cardioversion [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion referred to catheter ablation [Срок оценки: From enrollement to six months of follow-up.]
  • Proportion referred to pacemaker implantation [Срок оценки: From enrollement to six months of follow-up.]

Критерии участия

Критерии включения

\- 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07675434 · APHP260122

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗