Меню
Идёт набор NCT06865326

Early Detection of CTEPH in Patients After APE

— Наблюдательное Chronic Pulmonary Thromboembolism

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
В протоколе указаны: Standardized CTEPH Screening Protocol.
Кому может быть актуально
Состояния в реестре: Chronic Pulmonary Thromboembolism. 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
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Early Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients After Acute Pulmonary Embolism

Обзор

The project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Chronic tromboembolic pulmonary hypertesion in such a way as to ensure the maximum positive impact on the health of the population and high cost-effectiveness of the whole process.

Подробное описание

The project is a national, prospective, multicenter, observational pilot project of screening CTEPH in pacients after APE in the Czech Republic.

The global goal of the project is to develop, test and implement a uniform procedure for early detection of patients with CTEPH and to set up a process for their rapid referral to a specialized center that treats chronic thromboembolic pulmonary hypertension. The timeliness of the treatment set up has a significant impact on patient's future quality of life and eliminates the risk of subsequent complications or death.

The main objective of this activity is to validate the CTEPH screening process, which will benefit 500 patients in approximately 10 selected centres. Subsequently, patient flow from the cardiologist to a specialised pulmonary hypertension treatment centre will be ensured. The process will include a review and evaluation of the screening algorithm in patients in the pilot.

The project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22\_005/0002007

Вмешательства

  • Другое Standardized CTEPH Screening Protocol
    Implementation of a standardized screening algorithm for early detection of CTEPH in patients after Acute Pulmonary Embolism (APE) and establishment of optimized referral of patients to specialized centers.

Первичные конечные точки

  • Positive predictive value of initial examination [Срок оценки: Up to six months from enrollment]
  • CTEPH detection rates [Срок оценки: Up to six months from enrollment]
  • Proportion of people with suspected CTEPH who attended a follow-up examination at a specialized pulmonary hypertension treatment centre [Срок оценки: Up to six months from enrollment]

Критерии участия

Критерии включения

  • Age over 18 years
  • Signed consent to participate in the project and GDPR
  • Patients with an episode of acute pulmonary embolism in the last 3-12 months, with ongoing anticoagulation therapy:
  • Patients with new-onset and ongoing or progressive dyspnea (min. NYHA II) after a pulmonary embolism episode or worsening of dyspnea after a pulmonary embolism episode compared to the status before the episode (at least 1 HYHA grade) or
  • Asymptomatic patients after a pulmonary embolism episode and at least one of the following risk factors:
  • ECHO evidence of severe PH at diagnosis of PE (PASP >60 mmHg)
  • Antiphospholipid syndrome with triple positivity (presence of lupus anticoagulans + anti-beta-2-glycoprotein I (B2GPI) antibodies + anticardiolipin)
  • Infected permanent venous inlets and cardiac pacing/defibrillation intravascular systems
  • Presence of ventriculoatrial shunt for treatment of hydrocephalus
  • Nonspecific intestinal inflammation (ulcerative colitis, Crohn's disease)
  • History of splenectomy
  • Myeloproliferative disorders
  • Chronic osteomyelitis

Критерии исключения

  • Not agreeing to participate in the project
  • Contraindications to treatment

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Чехия · 10 центров
  • Brno University Hospital — Brno
  • Havlíčkův Brod Hospital — Havlíčkův Brod
  • University Hospital Hradec Králové — Hradec Králové
  • Jihlava Hospital — Jihlava
  • Náchod Hospital — Náchod
  • University Hospital Olomouc — Olomouc
  • University Hospital Ostrava — Ostrava
  • Pardubice Hospital — Pardubice
  • … и ещё 2 центра

Идентификаторы

NCT: NCT06865326 · UZIS 2024/2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗