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

May 1, 2018 updated by: Dara O'Neill, University College, London

Percutaneous Coronary Interventions in the UK: The Relationship Between Procedural Volumes and Patient Outcomes in a Changing 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

427467

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E 6BT
        • University College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Sample
All percutaneous coronary intervention patients who meet the primary eligibility criteria for this study.
Procedure: Percutaneous Coronary Intervention
Other Names:
  • PCI
  • Coronary angioplasty
Subsample
Patients drawn from the main sample who specifically underwent a primary percutaneous coronary intervention procedure.
Procedure: Primary Percutaneous Coronary Intervention
Other Names:
  • pPCI
  • Primary angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 30 days post-procedure
30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

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

Investigators

  • Principal Investigator: D O'Neill, PhD, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 3, 2014

First Submitted That Met QC Criteria

July 3, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NICOR-PCI-VolOut

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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