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An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians

2026年6月3日 更新者:Fiona Macrae、Gloucestershire Hospitals NHS Foundation Trust

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

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.

研究概览

地位

尚未招聘

详细说明

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.

研究类型

观察性的

注册 (估计的)

850

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Gloucestershire
      • Gloucester、Gloucestershire、英国、GL1 3NN
        • Gloucestershire Hospitals NHS Foundation Trust
        • 接触:
          • R&I Professional Services Manager
          • 电话号码:+44 300 422 5460
          • 邮箱:chris.ford1@nhs.net
        • 首席研究员:
          • Fiona Macrae, MBBS

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023 and were aged 80 years and older.

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Octogenarians who had PCI between 2017-2023
Percutaneous Coronary Intervention for example balloon angioplasty and balloon angioplasty with stent insertion.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Myocardial infarction
大体时间:1 year
Number of participants who suffered a myocardial infarction post-procedure.
1 year
Unplanned revascularisation
大体时间:1 year
The number of participants who had unplanned revascularisation.
1 year
Cerebrovascular accident
大体时间:1 year.
The number of participants who suffered a cerebrovascular accident
1 year.
Unplanned cardiac readmission
大体时间:1 year.
The number of participants who had an unplanned readmission to the cardiac ward.
1 year.
Death
大体时间:1 year
Death from any cause.
1 year
Arterial complication
大体时间:1 year.
The number of participants who suffered an inpatient arterial complication.
1 year.
Blood transfusion
大体时间:1 year.
The number of participants who required an inpatient blood transfusion.
1 year.
Renal replacement therapy
大体时间:1 year.
The number of participants who required inpatient renal replacement therapy.
1 year.
Gastrointestinal bleed
大体时间:1 year
The number of participants who suffered an upper gastrointestinal bleed.
1 year
Tamponade
大体时间:1 year
The number of participants who experienced an inpatient cardiac tamponade.
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年5月25日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年6月8日

上次提交的符合 QC 标准的更新

2026年6月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

It has not been stated within the ethical approval for this study that the investigators will share the data with other researchers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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