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Идёт набор NCT03787745

Ischemic Postconditioning in STEMI Patients Treated With Primary PCI

Без фазы С лечением ST Segment Elevation Myocardial Infarction

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: Ischemic postconditioning, Conventional.
Кому может быть актуально
Состояния в реестре: ST Segment Elevation Myocardial Infarction. 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Ischemic Postconditioning in Patients With STEMI Undergoing Primary PCI (DANAMI4-iPOST2)

Обзор

In a prospective, randomized clinical trial the iPOST2 trial will determine whether ischemic postconditioning reduces reperfusion injury and this will translate into improved clinical outcome of heart failure and death for STEMI patients who present with TIMI0-1 undergoing primary PCI

Подробное описание

Myocardial reperfusion with the use primary percutaneous coronary intervention (PCI) is effective, but restoration of blood flow may itself jeopardize the myocardium, a phenomenon known as reperfusion injury.

In ischemic postconditioning (iPOST), repetitive interruptions of blood flow to the injured region applied after initial reperfusion, has been shown favorable with different modalities such as biomarkers, echocardiography and cardiac magnetic resonance.

However, the largest trial to date (DANAMI3-iPOST) failed to show clinical favor of iPOST when compared to conventional PCI. Importantly, however, in DANAMI3-iPOST thrombectomy was allowed and this might have impaired postconditioning, since thrombectomy itself creates reperfusion and thus reperfusion damage. Analysis of the fraction of DANAMI3-iPOST patients not undergoing thrombectomy showed a remarkable 45% reduction in death and heart failure in favor of postconditioning.

iPOST2 will investigate in a randomized, prospective and adequately powered trial the effect of iPOST without thrombectomy compared to conventional PCI on the development of heart failure and death in STEMI patients.

Вмешательства

  • Процедура Ischemic postconditioning
    After 60 seconds of reperfusion, ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed
  • Процедура Conventional
    State of the art primary PCI, however thrombectomy is not allowed

Первичные конечные точки

  • All cause mortality or hospitalization for heart failure [Срок оценки: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months]
Вторичные конечные точки (8)
  • All cause mortality [Срок оценки: From date of randomization until the date of first documented death from any cause assessed up to 280 events have been adjudicated or up to 36 months]
  • Percentage of patients hospitalized for heart failure [Срок оценки: From date of randomization until the date of first documented hospitalization for heart failure assessed up to 280 events have been adjudicated or up to 36 months]
  • Percentage of patients with myocardial infarction [Срок оценки: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months]
  • Cardiovascular death [Срок оценки: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months]
  • Percentage of patients with stroke [Срок оценки: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months]
  • Percentage of patients with a combination of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia [Срок оценки: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months]
  • Percentage of patients with a combination of hospitalization for heart failure and cardiovascular death [Срок оценки: From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months]
  • Danish eq5d5l standard Quality of life [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Acute onset of chest pain with < 12 hours duration
  • STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior AMI.
  • TIMI flow 0-1 in infarct related artery

Критерии исключения

  • Potential pregnancy
  • Refusal to participate
  • OHCA without subsequent consciousness despite ROSC
  • Thrombectomy considered unavoidable

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

Дания · 1 центр
  • The Heart Center, Rigshospitalet, University of Copenhagen — Copenhagen

Публикации

  • Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Clemmensen P, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Ravkilde J, Tilsted HH, Villadsen A, Aaroe J, Jensen SE, Raungaard B, Botker HE, Terkelsen CJ, Maeng M, Kaltoft A, Krusell LR, Jensen LO, Veien KT, Kofoed KF, Torp-Pedersen C, Kyhl K, Nepper-Christensen L, Treiman M, Vejlstrup N, Ahtarovski K, Lonborg J, Kober L; Third Danish PMID 28249094

Идентификаторы

NCT: NCT03787745 · H-18051256

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗