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An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07633964
Enrollment
850
Registered
2026-06-08
Start date
2026-06-01
Completion date
2027-06-01
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardio Vascular Disease

Keywords

cardiovascular, octogenarian, frailty, SYNTAX, Percutaneous Coronary Intervention, calcification severity

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREPercutaneous Coronary Intervention

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

Sponsors

Gloucestershire Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Myocardial infarction1 yearNumber of participants who suffered a myocardial infarction post-procedure.
Unplanned revascularisation1 yearThe number of participants who had unplanned revascularisation.
Cerebrovascular accident1 year.The number of participants who suffered a cerebrovascular accident
Unplanned cardiac readmission1 year.The number of participants who had an unplanned readmission to the cardiac ward.
Death1 yearDeath from any cause.
Arterial complication1 year.The number of participants who suffered an inpatient arterial complication.
Blood transfusion1 year.The number of participants who required an inpatient blood transfusion.
Renal replacement therapy1 year.The number of participants who required inpatient renal replacement therapy.
Gastrointestinal bleed1 yearThe number of participants who suffered an upper gastrointestinal bleed.
Tamponade1 yearThe number of participants who experienced an inpatient cardiac tamponade.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026