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NCT Number: NCT07633964

An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians

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.

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Key information

Conditions

Cardio Vascular Disease Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

Location contact

Fiona Macrae, MBBS

PRINCIPAL_INVESTIGATOR

R&I Professional Services Manager

CONTACT

[email protected]

+44 300 422 5460

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous coronary intervention

Procedure

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

Primary outcomes

  1. Myocardial infarction

    Time frame: 1 year

    Number of participants who suffered a myocardial infarction post-procedure.

  2. Unplanned revascularisation

    Time frame: 1 year

    The number of participants who had unplanned revascularisation.

  3. Cerebrovascular accident

    Time frame: 1 year.

    The number of participants who suffered a cerebrovascular accident

  4. Unplanned cardiac readmission

    Time frame: 1 year.

    The number of participants who had an unplanned readmission to the cardiac ward.

  5. Death

    Time frame: 1 year

    Death from any cause.

  6. Arterial complication

    Time frame: 1 year.

    The number of participants who suffered an inpatient arterial complication.

  7. Blood transfusion

    Time frame: 1 year.

    The number of participants who required an inpatient blood transfusion.

  8. Renal replacement therapy

    Time frame: 1 year.

    The number of participants who required inpatient renal replacement therapy.

  9. Gastrointestinal bleed

    Time frame: 1 year

    The number of participants who suffered an upper gastrointestinal bleed.

  10. Tamponade

    Time frame: 1 year

    The number of participants who experienced an inpatient cardiac tamponade.

Sponsors and collaborators

Lead sponsor

Gloucestershire Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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