NCT07633964

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

May 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

May 25, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

cardiovascularoctogenarianfrailtySYNTAXPercutaneous Coronary Interventioncalcification severity

Outcome Measures

Primary Outcomes (10)

  • 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.

  • 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

Study Arms (1)

Octogenarians who had PCI between 2017-2023

Procedure: Percutaneous Coronary Intervention

Interventions

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

Octogenarians who had PCI between 2017-2023

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

Location

MeSH Terms

Conditions

Frailty

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Clinical Fellow

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations