Skip to main content
OpenTrials
Completed

NCT Number: NCT02184949

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University College London

London, WC1E 6BT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous coronary intervention

Procedure

Other names: PCI, Coronary angioplasty

Primary percutaneous coronary intervention

Procedure

Other names: pPCI, Primary angioplasty

Primary outcomes

  1. All-cause mortality

    Time frame: 30 days post-procedure

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • British Cardiovascular Intervention Society
  • British Cardiovascular Society
  • National Institute for Cardiovascular Outcomes Research

Registry information

Official study title

Percutaneous Coronary Interventions in the UK: The Relationship Between Procedural Volumes and Patient Outcomes in a Changing Context (A NICOR Study)

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 9, 2014
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.