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| ID | Type | Description | Link |
|---|---|---|---|
| 26/WM/0104 | Other Identifier | REC Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octogenarians who had PCI between 2017-2023 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention | Procedure | Percutaneous Coronary Intervention for example balloon angioplasty and balloon angioplasty with stent insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction | Number of participants who suffered a myocardial infarction post-procedure. | 1 year |
| Unplanned revascularisation | The number of participants who had unplanned revascularisation. | 1 year |
| Cerebrovascular accident | The number of participants who suffered a cerebrovascular accident | 1 year. |
| Unplanned cardiac readmission | The number of participants who had an unplanned readmission to the cardiac ward. | 1 year. |
| Death | Death from any cause. | 1 year |
| Arterial complication | The number of participants who suffered an inpatient arterial complication. | 1 year. |
| Blood transfusion | The number of participants who required an inpatient blood transfusion. | 1 year. |
| Renal replacement therapy | The number of participants who required inpatient renal replacement therapy. | 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023 and were aged 80 years and older.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gloucestershire Hospitals NHS Foundation Trust | Gloucester | Gloucestershire | GL1 3NN | United Kingdom |
It has not been stated within the ethical approval for this study that the investigators will share the data with other researchers.
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Gastrointestinal bleed |
The number of participants who suffered an upper gastrointestinal bleed. |
| 1 year |
| Tamponade | The number of participants who experienced an inpatient cardiac tamponade. | 1 year |
| D019060 | Minimally Invasive Surgical Procedures |