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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02184949
First Posted: July 9, 2014
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute for Cardiovascular Outcomes Research
British Cardiovascular Society
British Cardiovascular Intervention Society
Information provided by (Responsible Party):
Darragh O'Neill, University College, London
  Purpose
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.

Condition Intervention
Percutaneous Coronary Intervention Procedure: Percutaneous Coronary Intervention Procedure: Primary Percutaneous Coronary Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Percutaneous Coronary Interventions in the UK: The Relationship Between Procedural Volumes and Patient Outcomes in a Changing Context (A NICOR Study)

Further study details as provided by Darragh O'Neill, University College, London:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 30 days post-procedure ]

Enrollment: 427467
Study Start Date: January 2014
Study Completion Date: April 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184949


Locations
United Kingdom
University College London
London, United Kingdom, WC1E 6BT
Sponsors and Collaborators
University College, London
National Institute for Cardiovascular Outcomes Research
British Cardiovascular Society
British Cardiovascular Intervention Society
Investigators
Principal Investigator: D O'Neill, PhD University College, London
  More Information

Responsible Party: Darragh O'Neill, Information Analyst, University College, London
ClinicalTrials.gov Identifier: NCT02184949     History of Changes
Other Study ID Numbers: NICOR-PCI-VolOut
First Submitted: July 3, 2014
First Posted: July 9, 2014
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Darragh O'Neill, University College, London:
PCI
Coronary angioplasty
Percutaneous transluminal coronary angioplasty
PTCA