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Набор скоро начнётся NCT07633964

An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians

— Наблюдательное Cardio Vascular 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: Percutaneous Coronary Intervention.
Кому может быть актуально
Состояния в реестре: Cardio Vascular Disease. Базовые параметры: от 80 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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Официальное название

An Observational Study Looking at the Demographics and Outcomes of Octogenarians Undergoing Percutaneous Coronary Intervention (PCI) Over a Seven-year Period at a Primary Percutaneous Coronary Intervention (PPCI) Centre With Off-site Cardiothoracic Support

Обзор

The goal of this observational study is to understand the makeup of the participants aged 80 years and older who had stents fitted or balloon expansion of their heart arteries, otherwise known as percutaneous coronary intervention (PCI), at our hospital over a seven year period. The investigators will aim to describe the cohort with respect to their health conditions, age and frailty in addition to whether their procedure was planned or an emergency. The investigators will also look at the outcomes of these participants up to one year post procedure. The secondary aim is to look for associations between participant variables and their outcomes in hospital and at 1 year. The specific outcomes the investigators will look at are: inpatient complications and the incidence of heart attacks, strokes, unplanned PCI, cardiac rehospitalisation or death.

Подробное описание

The project is a retrospective observational study designed to look at the demographics, clinical presentation, comorbidities, angiographic findings, procedural factors and outcomes of participants aged 80 years and over (octogenarians) who had percutaneous coronary intervention (PCI) at our hospital trust between 1st January 2017 and 31st December 2023. The data will be reviewed to form a detailed description of the characteristics of the cohort. It will then be analysed to determine if there are associations between certain participant variables and outcomes, including inpatient complication rates and the rate of Major Adverse Cardiovascular Events (MACE) at one-year post procedure. The initial data will be identified from the local database which is required to be maintained and submitted to the UK's National Institute for Cardiovascular Outcomes Research (NICOR) database. Missing data or additional data not captured on this database, such as participant frailty and the coronary artery disease severity and complexity (measured by the SYNTAX score), will be collected from a combination of patient letters and Electronic Patient Records (EPR), including blood test results and imaging. Experienced interventional cardiologists will analyse the angiograms to collect the pre and post intervention SYNTAX score in addition to the angiography-derived calcification severity of the culprit artery. The data will be analysed to describe the cohort in detail. Univariate and multivariate cox regression analysis will be used to establish any associations between variables such as participant frailty, angiography-derived calcification severity and residual SYNTAX score with participant outcomes.

Вмешательства

  • Процедура Percutaneous Coronary Intervention
    Percutaneous Coronary Intervention for example balloon angioplasty and balloon angioplasty with stent insertion.

Первичные конечные точки

  • Myocardial infarction [Срок оценки: 1 year]
  • Unplanned revascularisation [Срок оценки: 1 year]
  • Cerebrovascular accident [Срок оценки: 1 year.]
  • Unplanned cardiac readmission [Срок оценки: 1 year.]
  • Death [Срок оценки: 1 year]
  • Arterial complication [Срок оценки: 1 year.]
  • Blood transfusion [Срок оценки: 1 year.]
  • Renal replacement therapy [Срок оценки: 1 year.]
  • Gastrointestinal bleed [Срок оценки: 1 year]
  • Tamponade [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023.

Критерии исключения

  • Participants with negative pressure wire studies (i.e. the lesion identified was not flow restricting).
  • Participants had "failed PCI".
  • Participants with significantly incomplete data despite thorough review of the electronic records.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Gloucestershire Hospitals NHS Foundation Trust — Gloucester

Идентификаторы

NCT: NCT07633964 · 25/085/GHT · 26/WM/0104

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗