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An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians

3. juni 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

850

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Gloucestershire
      • Gloucester, Gloucestershire, Storbritannia, GL1 3NN
        • Gloucestershire Hospitals NHS Foundation Trust
        • Ta kontakt med:
          • R&I Professional Services Manager
          • Telefonnummer: +44 300 422 5460
          • E-post: chris.ford1@nhs.net
        • Hovedetterforsker:
          • Fiona Macrae, MBBS

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Octogenarians who had PCI between 2017-2023
Percutaneous Coronary Intervention for example balloon angioplasty and balloon angioplasty with stent insertion.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Myocardial infarction
Tidsramme: 1 year
Number of participants who suffered a myocardial infarction post-procedure.
1 year
Unplanned revascularisation
Tidsramme: 1 year
The number of participants who had unplanned revascularisation.
1 year
Cerebrovascular accident
Tidsramme: 1 year.
The number of participants who suffered a cerebrovascular accident
1 year.
Unplanned cardiac readmission
Tidsramme: 1 year.
The number of participants who had an unplanned readmission to the cardiac ward.
1 year.
Death
Tidsramme: 1 year
Death from any cause.
1 year
Arterial complication
Tidsramme: 1 year.
The number of participants who suffered an inpatient arterial complication.
1 year.
Blood transfusion
Tidsramme: 1 year.
The number of participants who required an inpatient blood transfusion.
1 year.
Renal replacement therapy
Tidsramme: 1 year.
The number of participants who required inpatient renal replacement therapy.
1 year.
Gastrointestinal bleed
Tidsramme: 1 year
The number of participants who suffered an upper gastrointestinal bleed.
1 year
Tamponade
Tidsramme: 1 year
The number of participants who experienced an inpatient cardiac tamponade.
1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

25. mai 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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