ClinicalTrials.gg
CompletedNCT02184949Updated May 4, 2018

Exploring the Volume-Outcome Relationship for PCI Procedures Undertaken in a UK Context: A NICOR Study

An observational study in Percutaneous Coronary Intervention, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-04.

Sponsored by University College, London · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
427,467
Ages
18 Years and older
Sex
All
01

Study summary

The relationship between annual procedural volume and patient outcome remains a debated issue in the field of interventional medicine. An under-explored issue in a UK context is whether or not such a relationship exists for percutaneous coronary interventions (PCI). In recent years, this procedure has replaced thrombolysis as the standard intervention method used in UK hospitals for widening patients' obstructed coronary arteries. However, the actual number of such procedures currently undertaken annually remains variable across hospitals where these interventions are performed. The UK's National Institute for Health and Care Excellence has consequently called for research into whether such differences in volume play any role in patient outcome for this particular procedure. The current study is intended to address that research need, and will do so by looking at whether the annual number of PCI procedures undertaken by individual hospitals is predictive of patient mortality post-procedure.

Read the detailed description

Using data collected as part of a UK national audit of percutaneous coronary interventions, this study will:

  • Establish whether annual hospital volume is a clinically important novel risk factor for 30-day mortality post-PCI when examined relative to a newly developed risk model intended for use in clinical practice.
  • Establish whether the nature of this volume-outcome relationship is best fit as a linear or non-linear model.
  • Establish whether annual hospital volume is a clinically important novel risk factor for 30-day mortality post-primary PCI when examined relative to a newly developed risk model intended for use in clinical practice.
02

Conditions studied

  • Percutaneous Coronary Intervention

Keywords

  • PCI
  • Coronary angioplasty
  • Percutaneous transluminal coronary angioplasty
  • PTCA
03

In context

Lead sponsor

University College, London is the lead sponsor of 647 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Percutaneous coronary interventions undertaken in UK hospitals are recorded in the UK National Audit of Percutaneous Coronary Intervention. Patients who contribute data to this audit will be eligible for inclusion in this study. Additional inclusion criteria, as described below, will be applied to ensure that data are appropriate for the intended analysis.

Eligibility criteria

Inclusion Criteria:

  • are aged between 18 and 100 (inclusive) on the date of their procedure;
  • do not have pre-operative ventilation;
  • undergo a PCI procedure in a UK hospital that contributes data to the National Audit of Percutaneous Coronary Intervention; and
  • have a tracked mortality status at 30 days' post-procedure.

To account for potential dependencies in the data, patients' non-index (i.e. follow-up) PCI procedures occurring during the data collection period will be excluded from the study sample.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
427,467 participants (actual)
Patient registry
No

Groups and cohorts

  • Primary Sample

    All percutaneous coronary intervention patients who meet the primary eligibility criteria for this study.

    Procedure: Percutaneous Coronary Intervention

  • Subsample

    Patients drawn from the main sample who specifically underwent a primary percutaneous coronary intervention procedure.

    Procedure: Primary Percutaneous Coronary Intervention

Interventions

  • ProcedurePercutaneous Coronary Intervention

    Also known as: PCI, Coronary angioplasty

  • ProcedurePrimary Percutaneous Coronary Intervention

    Also known as: pPCI, Primary angioplasty

06

What researchers measure

Primary outcomes

  1. All-cause mortality

    Time frame: 30 days post-procedure

07

Study locations

1 site
  • University College London
    London, WC1E 6BT, United Kingdom
08

References and documents

Publications

  • O'Neill D, Nicholas O, Gale CP, Ludman P, de Belder MA, Timmis A, Fox KA, Simpson IA, Redwood S, Ray SG. Total Center Percutaneous Coronary Intervention Volume and 30-Day Mortality: A Contemporary National Cohort Study of 427 467 Elective, Urgent, and Emergency Cases. Circ Cardiovasc Qual Outcomes. 2017 Mar;10(3):e003186. doi: 10.1161/CIRCOUTCOMES.116.003186. PubMed 28320707 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02184949
Collaborators
National Institute for Cardiovascular Outcomes Research, British Cardiovascular Society, British Cardiovascular Intervention Society
Responsible party
Dara O'Neill (Information Analyst, University College, London) — Principal investigator
First posted
Jul 9, 2014
Start date
Jan 2014
Primary completion
Dec 2014
Completion
Apr 2015
Last update
May 4, 2018

Study contacts

D O'Neill, PhD
principal investigator · University College, London

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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