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Идёт набор NCT06875583

The Radiation ProtEction for Dose RedUction in the Cardiac CathEter Lab Study: The REDUCE Trial

Без фазы С лечением Radiation Exposure Radiation Exposure to Operator Radiation Injuries Radiation Safety

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: Radiation.
Кому может быть актуально
Состояния в реестре: Radiation Exposure, Radiation Exposure to Operator, Radiation Injuries, Radiation Safety. 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
Великобритания
Следующий шаг
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Обзор

Doctors and nurses who perform heart procedures using X-ray guidance are exposed to radiation, which can be harmful over time. This exposure increases the risk of certain health problems, including cancers, eye damage (cataracts), and DNA damage. Although protective lead clothing is used to reduce exposure, it is heavy, uncomfortable, and can cause muscle and joint problems for those who wear it daily. A new radiation protection device, called RAMPART, may help reduce radiation exposure for heart specialists and their teams. It could also allow them to wear lighter protective gear-or none at all-making their work safer and more comfortable. This study will compare the radiation levels received by doctors and nurses during heart procedures when using RAMPART versus standard protection. By doing so, we hope to find out if this new device can better protect medical teams from radiation, improving both their safety and well-being.

Подробное описание

Recent decades have seen major increases in x-ray guided procedures in interventional cardiology, radiology and vascular surgery. Exposure to ionising radiation is known to be an inherent risk and remains a serious and unresolved threat to the health of operators and their team. It is associated with an increased incidence of brain and blood cancers, cataracts, and recent mechanistic data indicates significantly increased DNA damage in those without leaded leg protection.

Although existing standard radiation protection measures somewhat reduces exposure, all cardiac catheter lab personnel still receive a certain dose of radiation and continue to accumulate lifetime exposure. Furthermore, leaded personal protective equipment is heavy, leads to orthopaedic complications, and detracts from operator comfort.

Novel radiation protection devices such as RAMPART may significantly reduce radiation doses to cardiac catheter lab personnel, and potentially allow the use of lighter lead, or no lead at all. In this study we aim to investigate if use of RAMPART significantly reduces radiation exposure, when compared with standard radiation protection. Standard coronary intervention procedures will be randomised to RAMPART or standard (radiation protection), and operators and Cath lab team doses will be compared.

Вмешательства

  • Устройство Radiation
    The use of RAMPART radiation protection device

Первичные конечные точки

  • 1st Operator Eye radiation [Срок оценки: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year]
Вторичные конечные точки (3)
  • 1st Operator Chest / Groind radiation [Срок оценки: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year]
  • 2nd Operator Radiation - all levels [Срок оценки: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year]
  • 'Circulating Nurse' Radiation [Срок оценки: 1) Periprocedural 2) Cumulative dose - through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • All procedures involving adult patients (>18 year of age)
  • Male or female patients
  • Planned to undergo either an elective or urgent coronary intervention procedure involving ionising radiation in the cardiac catheter lab, via the right and or left radial arteries.

Критерии исключения

  • Procedures involving patients less than 18 years of age
  • Patients unable to give valid consent
  • Pregnancy
  • Femoral approach procedure

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Великобритания · 1 центр
  • Liverpool Heart & Chest Hospital — Liverpool

Публикации

  • Lisko JC, Shekiladze N, Chamoun J, Sheikh N, Rainer K, Wei J, Binongo J, Raj L, Byku I, Rinfret S, Devireddy C, Jaber WA, Greenbaum AB, Babaliaros V, Steuterman S, Sandesara P, Nicholson WJ. Radiation Exposure Using Rampart vs Standard Lead Aprons and Shields During Invasive Cardiovascular Procedures. J Soc Cardiovasc Angiogr Interv. 2023 Oct 19;3(1):101184. doi: 10.1016/j.jscai.2023.101184. eColl PMID 39131978
  • Noor HA, Althawadi N, Noor Z, AlAnsari N, Chachar TS, Al Raisi S, Yousif N. Radiation Exposure During Invasive Cardiovascular Procedures: Portable Shielding System Versus Standard Lead Aprons. Cureus. 2024 Aug 29;16(8):e68108. doi: 10.7759/cureus.68108. eCollection 2024 Aug. PMID 39350833

Идентификаторы

NCT: NCT06875583 · REDUCE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗