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Набор скоро начнётся NCT06565793

A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

— Наблюдательное Myocardial Infarction (MI) Radiation Toxicity Coronary Stenosis Coronary Thrombosis

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: Non Complex PCI, Complex PCI.
Кому может быть актуально
Состояния в реестре: Myocardial Infarction (MI), Radiation Toxicity, Coronary Stenosis, Coronary Thrombosis. Базовые параметры: 18 лет — 90 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.

Обзор

In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.

Подробное описание

A retrospective database of the hemodynamics department of the Centre Cardiologique du Nord and Clinica Mediterranea, comprising 15,630 consecutive angioplasties performed in unselected patients between February 1, 2008, and July 7, 2018, was used to identify complex angioplasties and standard angioplasties. Two categories of complex angioplasty were identified: complex angioplasty with a single complexity criterion and very complex angioplasty with two or more complexity criteria. These complex angioplasties were then compared with standard angioplasty (angioplasty with no complexity criteria).

The following criteria were employed to delineate complex or very complex angioplasties:

* Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI) * Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI) * Angioplasty of Chronic Coronary Occlusion (CCO-PCI) * Angioplasty of a Bifurcation Lesion (CBL-PCI)

The following definitions pertain to the classification of angioplasty procedures:

* Standard angioplasty: This encompasses angioplasty procedures that do not meet the criteria for complexity. * Complex angioplasty: This designation is applied to angioplasty procedures that meet at least one criterion for complexity. * Very complex angioplasty: This designation is applied to angioplasty procedures that meet at least two criteria for complexity.

Вмешательства

  • Устройство Non Complex PCI
    The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).
  • Устройство Complex PCI
    The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).This designation is applied to angioplasty procedures that meet at least one criterion for complexity. The complex angioplasty involved patients with unprotected left coronary common trunk (UT-PCI), the use of rotablator rotary atherectomy (ARota-PCI), the angioplasty of c

Первичные конечные точки

  • Death [Срок оценки: 30 days]
  • Death [Срок оценки: 1 year]
  • Death [Срок оценки: 5 years]
  • Myocardial Infarction [Срок оценки: 30 days]
  • Myocardial Infarction [Срок оценки: 1 year]
  • Myocardial Infarction [Срок оценки: 5 years]
  • Stent Thrombosis [Срок оценки: 30 days]
  • Stent Thrombosis [Срок оценки: 1 year]
  • Stent Thrombosis [Срок оценки: 5 years]
  • Acute Kidney Injury [Срок оценки: 30 days]
Вторичные конечные точки (4)
  • Target Vessel Revascularization [Срок оценки: 1 year]
  • Target Vessel Revascularization [Срок оценки: 5 years]
  • Target Lesion Revascularization [Срок оценки: 1 year]
  • Target Lesion Revascularization [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.

Критерии исключения

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06565793 · ID: CN-08-24

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗