Меню
Идёт набор NCT04748237

Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

Без фазы С лечением Chest Pain Acute Coronary Syndrome Coronary Artery Disease

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: Coronary computed tomopraphic angiography.
Кому может быть актуально
Состояния в реестре: Chest Pain, Acute Coronary Syndrome, Coronary Artery Disease. 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
Швеция
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

Randomized Evaluation of Coronary Computed Tomographic Angiography in Intermediate-risk Patients Presenting to the Emergency Department With Chest Pain

Обзор

The aim is to determine whether a diagnostic strategy including early coronary computed tomographic angiography in intermediate-risk patients presenting to the Emergency Department with chest pain reduces the composite endpoint of death, readmission because of myocardial infarction or unstable angina requiring revascularization.

Подробное описание

Patients presenting to the ED with chest pain or other symptoms suggestive of ACS, without acute MI but with an intermediate risk (HEART-score \>3) will after written informed consent be randomized to either a strategy with an initial CCTA or not.

Patients randomized to strategy including early CCTA will receive standard care according to responsible physician and perform a CCTA as soon as possible (in most cases within 24 hours, but at least within 21 days).The result will be presented to the responsible physician who will plan further care of the patients.

Patients randomized to a strategy not including early CCTA will receive further care (including examinations) according to responsible physician but not include early CCTA. These patients will often undergo a non-invasive functional test, such as Exercise-ECG, stress echocardiography or nuclear imaging according to local routines, but not always.

All patients should receive optimal prevention according to current guidelines. The responsible physician will be encouraged to initiate secondary prevention measures if examinations show signs of CAD.

The primary endpoint is composite of death, readmission because of MI or unstable angina requiring revascularization.

Вмешательства

  • Диагностический тест Coronary computed tomopraphic angiography
    CCTA as soon as possible, preferably within 24 hours, but not later than within 21 days.

Первичные конечные точки

  • The composite of death, readmission because of MI or unstable angina requiring revascularization [Срок оценки: through study completion, an average of 5 year]
Вторичные конечные точки (12)
  • Death or readmission because MI [Срок оценки: through study completion, an average of 5 year]
  • Death [Срок оценки: through study completion, an average of 5 year]
  • Cardiovascular death [Срок оценки: through study completion, an average of 5 year]
  • MI (fatal or non-fatal) [Срок оценки: through study completion, an average of 5 year]
  • Readmission because of unstable angina requiring revascularization [Срок оценки: through study completion, an average of 5 year]
  • Death, readmission because MI or stroke [Срок оценки: through study completion, an average of 5 year]
  • Stroke (fatal or non-fatal) [Срок оценки: through study completion, an average of 5 year]
  • Resource use / Health care costs [Срок оценки: through study completion, an average of 5 year]
  • Re-presentation to the ED because of chest pain [Срок оценки: through study completion, an average of 5 year]
  • Invasive coronary angiography [Срок оценки: through study completion, an average of 5 year]
  • Non-obstructive CAD at first invasive coronary angiography [Срок оценки: through study completion, an average of 5 year]
  • Angina [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Age≥18 years.
  • Within 24 hours from presenting to the ED with chest pain or other symptoms suggestive of coronary artery disease (CAD)
  • HEART-score >3 (according to http://www.heartscore.nl/)
  • Written informed consent obtained

Критерии исключения

  • Any condition that may influence the patient's ability to comply with study protocol.
  • Acute MI
  • Known obstructive CAD (>50%) or previous PCI or CABG.
  • Clear alternative diagnosis
  • Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
  • Major allergy to iodinated contrast media
  • Circumstances making high quality images unlikely.
  • Not a Swedish resident with a personal ID-number.
  • Pregnancy or breast feeding
  • Further investigation for CAD not indicated, due to limited life expectancy, quality of life or functional status
  • Previous inclusion in the trial

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
Диагностика

Центры проведения

Швеция · 1 центр
  • Danderyd Hospital — Stockholm

Идентификаторы

NCT: NCT04748237 · KIDS2020-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗