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Набор скоро начнётся NCT07004530

the MCCE vs EGD Trial

Без фазы С лечением Anaemia Acute Coronary Syndrome

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: Magnetically Controlled Capsule Endoscopy (MCCE), Esophageal-gastro-Duodenoscopy (EGD).
Кому может быть актуально
Состояния в реестре: Anaemia, Acute Coronary Syndrome. Базовые параметры: от 19 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
Гонконг
Следующий шаг
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Официальное название

Magnetically Controlled Capsule Endoscopy vs Esophago-gastro-Duodenoscopy as The Initial Investigation for Anaemia in Patients With Acute Coronary Syndrome (the MCCE vs EGD Trial) - a Single Centre Randomized Study

Обзор

Anaemia is common in patients with acute coronary syndrome (ACS) and is associated with significant recurrent bleeding risk and major adverse cardiovascular event (MACE). Esophageal-gastro-Duodenoscopy (EGD) is commonly used as an initial investigation for anaemia but is often non-diagnostic. Magnetically Controlled Capsule Endoscopy (MCCE) being less invasive and with comparable diagnostic accuracy as EGD, might be used as an alternative initial investigation for anaemia in patients with ACS.

Подробное описание

Anaemia is common in patients with acute coronary syndrome (ACS) and is associated with significant recurrent bleeding risk and major adverse cardiovascular event (MACE). Esophageal-gastro-Duodenoscopy (EGD) is commonly used as an initial investigation for anaemia but is often non-diagnostic. Magnetically Controlled Capsule Endoscopy (MCCE) being less invasive and with comparable diagnostic accuracy as EGD, might be used as an alternative initial investigation for anaemia in patients with ACS.

Вмешательства

  • Процедура Magnetically Controlled Capsule Endoscopy (MCCE)
    . The MCCE used in this study is the magnetically controlled capsule endoscopy (MCE, AnPx USA) which is a capsule measuring 28x12mm, and contains a permanent magnet inside its dome. Images are captured and recorded at 2 frames/s
  • Процедура Esophageal-gastro-Duodenoscopy (EGD)
    Esophageal-gastro-Duodenoscopy (EGD) is commonly performed to look for source of bleeding in patients with anaemia. However, from our own analysis and from retrospective studies of EGD in patients with ACS, EGD finding was normal or non-significant in 20-80% patients14-16. Moreover, EGD was associated with non-negligible periprocedural risks in patients with ACS, including death directly attributed to EGD (9.1%; 95% CI 7.6-10.9%), hypotension (24.1%; 95% CI 17.0-32.9%), arrhythmias (8.3%; 95% CI

Первичные конечные точки

  • the occurrence of recurrent bleeding [Срок оценки: baseline, 30 days]
Вторичные конечные точки (4)
  • Need for any transfusion [Срок оценки: baseline, 30 days]
  • Any bleeding by Thrombolysis in Myocardial Infarction (TIMI), Bleeding Academic Research Consortium (BARC) and GUSTO definitions [Срок оценки: baseline, 30 days]
  • Change in Major adverse cardiac events [Срок оценки: baseline, 30 days]
  • Any adverse events and complications from MCCE and/or from EGD [Срок оценки: baseline, 30 days]

Критерии участия

Критерии включения

subjects are patients older than 18 years old with:

  • the diagnosis of ACS as defined by symptoms of chest pain or shortness-of-breath, abnormal electrocardiogram and positive enzyme, requiring coronary intervention
  • new-onset anaemia as defined by Hb<11 g/dL on admission blood taking

Критерии исключения

  • History of active haematological disease including hemoglobinopathies such as thalassemia, Myelodysplastic syndromes, haematological malignancy, aplastic anaemia, or autoimmune haemolytic anaemia.
  • Patients with known active gastrointestinal malignancy.
  • Contraindications for CE: suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, presence of gastrointestinal obstruction symptoms such as pain or dysphagia; inoperative conditions or refusal to undergo abdominal surgery if required; history of laparotomy, gastric or bowel surgery; presence of metallic implants that is not MRI conditional.
  • Contraindications for EGD: Possible gastrointestinal perforation, medically unstable patients, patient with known pharyngeal diverticulum, and patients with recent head and neck trauma.
  • Inability to take 1-month DAPT such as non-deferrable surgery within 1 months, severe allergy or hypersensitivity reaction to aspirin or P2Y12 inhibitors, or patients in whom 1 months DAPT is not indicated.
  • Patients whose life-expectancy is less than 6 months.
  • Patients who are pregnant or lactating.
  • Patients who are unable to give informed consent.
  • Patients who are in active heart failure or fluid-overload state.
  • Patients who have chronic renal failure as defined by estimated glomerular filtration rate <15 ml/min/1.73m2.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • Prince of Wales Hospital — Гонконг

Идентификаторы

NCT: NCT07004530 · 2024.237

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗