- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07633964
An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians
3 juni 2026 uppdaterad av: Fiona Macrae, Gloucestershire Hospitals NHS Foundation Trust
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
850
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Gloucestershire
-
Gloucester, Gloucestershire, Storbritannien, GL1 3NN
- Gloucestershire Hospitals NHS Foundation Trust
-
Kontakt:
- R&I Professional Services Manager
- Telefonnummer: +44 300 422 5460
- E-post: chris.ford1@nhs.net
-
Huvudutredare:
- Fiona Macrae, MBBS
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Participants who had PCI at our hospital trust between 1st January 2017 - 31st December 2023 and were aged 80 years and older.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Octogenarians who had PCI between 2017-2023
|
Percutaneous Coronary Intervention for example balloon angioplasty and balloon angioplasty with stent insertion.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Myocardial infarction
Tidsram: 1 year
|
Number of participants who suffered a myocardial infarction post-procedure.
|
1 year
|
|
Unplanned revascularisation
Tidsram: 1 year
|
The number of participants who had unplanned revascularisation.
|
1 year
|
|
Cerebrovascular accident
Tidsram: 1 year.
|
The number of participants who suffered a cerebrovascular accident
|
1 year.
|
|
Unplanned cardiac readmission
Tidsram: 1 year.
|
The number of participants who had an unplanned readmission to the cardiac ward.
|
1 year.
|
|
Death
Tidsram: 1 year
|
Death from any cause.
|
1 year
|
|
Arterial complication
Tidsram: 1 year.
|
The number of participants who suffered an inpatient arterial complication.
|
1 year.
|
|
Blood transfusion
Tidsram: 1 year.
|
The number of participants who required an inpatient blood transfusion.
|
1 year.
|
|
Renal replacement therapy
Tidsram: 1 year.
|
The number of participants who required inpatient renal replacement therapy.
|
1 year.
|
|
Gastrointestinal bleed
Tidsram: 1 year
|
The number of participants who suffered an upper gastrointestinal bleed.
|
1 year
|
|
Tamponade
Tidsram: 1 year
|
The number of participants who experienced an inpatient cardiac tamponade.
|
1 year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 juni 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
25 maj 2026
Först inskickad som uppfyllde QC-kriterierna
3 juni 2026
Första postat (Faktisk)
8 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25/085/GHT
- 26/WM/0104 (Annan identifierare: REC Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
It has not been stated within the ethical approval for this study that the investigators will share the data with other researchers.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .