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

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184949
• Other study ID #: NICOR-PCI-VolOut
• Status: Completed
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2018
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427467
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Procedure:
• Percutaneous Coronary Intervention

• Primary Percutaneous Coronary Intervention

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (4)

Lead Sponsor	Collaborator
University College, London	British Cardiovascular Intervention Society, British Cardiovascular Society, National Institute for Cardiovascular Outcomes Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		30 days post-procedure