Cardio Vascular DiseaseNCT07633964
An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians
An observational study of Cardio Vascular Disease, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Cardio Vascular Disease
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 850 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023 and were aged 80 years and older.
Who may be able to join
- Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, GL1 3NN
R&I Professional Services Manager, +44 300 422 5460, chris.ford1@nhs.net
Fiona Macrae, MBBS
About this study
Official 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
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.
Read the 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.
- Conditions
- Cardio Vascular Disease
- Being tested
- Percutaneous Coronary Intervention
- Keywords
- cardiovascular, octogenarian, frailty, SYNTAX, Percutaneous Coronary Intervention, calcification severity
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Percutaneous Coronary Intervention for example balloon angioplasty and balloon angioplasty with stent insertion.
| Study group | Role | What they receive |
|---|---|---|
| Octogenarians who had PCI between 2017-2023 | Not described Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarction
Number of participants who suffered a myocardial infarction post-procedure.
Measured: 1 year
Unplanned revascularisation
The number of participants who had unplanned revascularisation.
Measured: 1 year
Cerebrovascular accident
The number of participants who suffered a cerebrovascular accident
Measured: 1 year.
Unplanned cardiac readmission
The number of participants who had an unplanned readmission to the cardiac ward.
Measured: 1 year.
Death
Death from any cause.
Measured: 1 year
Arterial complication
The number of participants who suffered an inpatient arterial complication.
Measured: 1 year.
Blood transfusion
The number of participants who required an inpatient blood transfusion.
Measured: 1 year.
Renal replacement therapy
The number of participants who required inpatient renal replacement therapy.
Measured: 1 year.
Gastrointestinal bleed
The number of participants who suffered an upper gastrointestinal bleed.
Measured: 1 year
Tamponade
The number of participants who experienced an inpatient cardiac tamponade.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona Macrae, Gloucestershire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633964
- Sponsor's protocol ID
- 25/085/GHT
- Other IDs
- 26/WM/0104
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It has not been stated within the ethical approval for this study that the investigators will share the data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07633964
- Acronym / sponsor ID
- 25/085/GHT
- Conditions
- Cardio Vascular Disease
- Keywords
- cardiovascular, octogenarian, frailty, SYNTAX, Percutaneous Coronary Intervention, calcification severity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Octogenarians who had PCI between 2017-2023 | – | Procedure: Percutaneous Coronary Intervention |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023 and were aged 80 years and older.
Key inclusion criteria (1 listed)
- Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary InterventionPercutaneous Coronary Intervention for example balloon angioplasty and balloon angioplasty with stent insertion. | Procedure or surgery | Octogenarians who had PCI between 2017-2023 |
Primary outcome
Myocardial infarction
Time frame: 1 year
Number of participants who suffered a myocardial infarction post-procedure.
Unplanned revascularisation
Time frame: 1 year
The number of participants who had unplanned revascularisation.
Cerebrovascular accident
Time frame: 1 year.
The number of participants who suffered a cerebrovascular accident
Unplanned cardiac readmission
Time frame: 1 year.
The number of participants who had an unplanned readmission to the cardiac ward.
Death
Time frame: 1 year
Death from any cause.
Arterial complication
Time frame: 1 year.
The number of participants who suffered an inpatient arterial complication.
Blood transfusion
Time frame: 1 year.
The number of participants who required an inpatient blood transfusion.
Renal replacement therapy
Time frame: 1 year.
The number of participants who required inpatient renal replacement therapy.
Gastrointestinal bleed
Time frame: 1 year
The number of participants who suffered an upper gastrointestinal bleed.
Tamponade
Time frame: 1 year
The number of participants who experienced an inpatient cardiac tamponade.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio Vascular Disease, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarction (time frame: 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.