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Идёт набор NCT05967663

Fractional Flow Reserve Guided Immediate Versus Staged Complete Myocardial Revascularization in Patients With ST-segment Elevation Myocardial Infarction With Multivessel Disease (Future Study)

Без фазы С лечением ST 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: PCI-immediate complete revascularisation, PCI-staged complete revascularisation.
Кому может быть актуально
Состояния в реестре: ST 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

It is a prospective, multicenter, randomised controlled, open-label, blinded endpoint assessment trial, to compare the strategy of immediate complete revascularisation and staged complete revascularisation in ST-segment-elevation myocardial infarction patients with multivessel coronary disease.

Подробное описание

Objectives: The purpose of this study is to investigate whether FFR guided PCI strategy for non-culprit lesions should be attempted during the index procedure or staged in ST-segment-elevation myocardial infarction patients with multivessel coronary disease.

Inclusion Criteria:

1. Age ≥ 18 years 2. Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours) 3. Multivessel disease was defined at least one non-culprit coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 50% stenosis by visual estimation, PCI can be successfully implemented 4. Sign an informed consent form before participating in the study

Exclusion Criteria:

1. Received thrombolytic therapy 2. Cardiac shock or SBP\<90mmHg; 3. History of old myocardial infarction; 4. Left main artery lesion, non infarct related vessels are CTO lesions; 5. PCI in the previous 30 days or Previous CABG 6. Patients who cannot give informed consent or have a life expectancy of less than 1 year 7. Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value\<30ml/min;), liver dysfunction and thrombocytopenia 8. Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension; 9. Not suitable for clinical research:

1. . Currently participating in another study that may affect the primary endpoint 2. . Pregnant and lactating women; 3. . Known allergy to drugs that may be used in the study; 4. . Unable to comply with the trial protocol or follow-up requirements; Or the researcher believes that participating in the trial may result in patients facing greater risks.

Вмешательства

  • Устройство PCI-immediate complete revascularisation
    In patients allocated to the immediate complete revascularisation group, PCI of the culprit lesion was attempted first and followed by all other lesions deemed to be clinically significant by the operator during the index procedure.
  • Устройство PCI-staged complete revascularisation
    In the staged complete revascularisation group, only the culprit lesion was treated during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator was planned at a later stage through an elective re-admission within 15-45 days after randomisation.

Первичные конечные точки

  • MACCE [Срок оценки: At 1 year after the index procedure]
Вторичные конечные точки (11)
  • MACCE [Срок оценки: At 1 months, 6 months, 2 and 3 years after the index procedure]
  • All-cause mortality [Срок оценки: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
  • Cardiovascular death [Срок оценки: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
  • Myocardial Infarction [Срок оценки: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
  • TVR: Target vessel revascularization [Срок оценки: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
  • Any coronary revascularization [Срок оценки: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
  • Stent Thrombosis [Срок оценки: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
  • Stroke (Ischemic\hemorrhagic) [Срок оценки: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
  • Hospitalization for heart failure [Срок оценки: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]
  • Contrast-induced acute kidney injury [Срок оценки: At 1 months after the index procedure]
  • Major bleeding [Срок оценки: At 1 months, 6 months, 1, 2 and 3 years after the index procedure]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Patients presenting STEMI and multivessel coronary disease successful primary PCI of the culprit lesion (including those who still have ischemic symptoms within 48 hours)
  • Multivessel disease was defined at least one non-culprit coronary arteries with a diameter of 2.5 mm or more and a maximum diameter at least 50% stenosis by visual estimation, PCI can be successfully implemented
  • Sign an informed consent form before participating in the study

Критерии исключения

  • Received thrombolytic therapy
  • Cardiac shock or SBP<90mmHg;
  • History of old myocardial infarction;
  • Left main artery lesion, non infarct related vessels are CTO lesions;
  • PCI in the previous 30 days or Previous CABG
  • Patients who cannot give informed consent or have a life expectancy of less than 1 year
  • Patients combined with other serious diseases such as severe renal dysfunction (creatinine clearance value<30ml/min;), liver dysfunction and thrombocytopenia
  • Patients with severe valve disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and primary pulmonary hypertension;
  • Not suitable for clinical research:
  • Currently participating in another study that may affect the primary endpoint
  • Pregnant and lactating women;
  • Known allergy to drugs that may be used in the study;
  • Unable to comply with the trial protocol or follow-up requirements; Or the researcher believes that participating in the trial may result in patients facing greater risks.

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

Китай · 1 центр
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT05967663 · Future Study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗