Percutaneous Coronary InterventionNCT02184949
Exploring the Volume-Outcome Relationship for PCI Procedures Undertaken in a UK Context: A NICOR Study
An observational study of Percutaneous Coronary Intervention, run by University College, London at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Percutaneous Coronary Intervention and Primary Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 427,467 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- Percutaneous Coronary Intervention, Primary Percutaneous Coronary Intervention
- Keywords
- PCI, Coronary angioplasty, Percutaneous transluminal coronary angioplasty, PTCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Also called PCI, Coronary angioplasty
Primary Percutaneous Coronary InterventionProcedure or surgery
Also called pPCI, Primary angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Primary Sample | All percutaneous coronary intervention patients who meet the primary eligibility criteria for this study. Receives: Procedure: Percutaneous Coronary Intervention | |
| Subsample | Patients drawn from the main sample who specifically underwent a primary percutaneous coronary intervention procedure. Receives: Procedure: Primary Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 427,467 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Cardiovascular Outcomes Research, British Cardiovascular Society, British Cardiovascular Intervention Society
- Responsible party
- Principal investigator, Dara O'Neill, University College, London
- Investigators
- D O'Neill, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184949
- Sponsor's protocol ID
- NICOR-PCI-VolOut
- Status last verified
- May 2018
- First submitted
- 3 Jul 2014
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Coronary Interventions in the UK: The Relationship Between Procedural Volumes and Patient Outcomes in a Changing Context (A NICOR Study)
- ClinicalTrials.gov ID
- NCT02184949
- Acronym / sponsor ID
- NICOR-PCI-VolOut
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- PCI, Coronary angioplasty, Percutaneous transluminal coronary angioplasty, PTCA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427,467 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Cardiovascular Outcomes Research, British Cardiovascular Society, British Cardiovascular Intervention Society
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Sample | – | Procedure: Percutaneous Coronary InterventionAll percutaneous coronary intervention patients who meet the primary eligibility criteria for this study. |
| Subsample | – | Procedure: Primary Percutaneous Coronary InterventionPatients drawn from the main sample who specifically underwent a primary percutaneous coronary intervention procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary InterventionAlso: PCI, Coronary angioplasty | Procedure or surgery | Primary Sample |
| Primary Percutaneous Coronary InterventionAlso: pPCI, Primary angioplasty | Procedure or surgery | Subsample |
Primary outcome
All-cause mortality
Time frame: 30 days post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Derived from this study: PubMed 28320707O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D O'Neill, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02184949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.