Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain? (RIPCORD)
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Purpose
The use of coronary angiography to investigate patients at risk of coronary artery narrowings has become universal. In most cases, this investigation leads to a successful treatment plan with revascularisation recommended where appropriate. However in a substantial number of patients, the images taken of the coronary arteries can lead to diagnostic uncertainty. Increasingly, doctors are using devices called pressure wires to clarify the significance of coronary artery narrowings in order to tailor patient treatment on an individual basis.
The Radi pressure wire is well recognised as a reliable tool in assessing whether a narrowing is significant in functional terms, that is, does it significantly restrict blood flow to the heart muscle.It consists of a fine wire that is fed into individual major coronary arteries to measure pressure within the vessel itself. In conjunction with the images taken of the arteries, it is very useful in deciding how best to treat patients.
This study enrolls volunteers who are being investigated for stable cardiac-sounding chest pain and are undergoing a coronary angiogram. It will investigate whether the extra information gained from pressure wire assessment will change patients' treatment plan.
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Device: Radi pressure wire (pressure wire assessment) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain? |
- Estimation of number of cases where FFR data results in a change in the management strategy the revascularisation strategy (number of vessel requiring treatment and/or PCI vs medical vs CABG) [ Time Frame: Up until hospital discharge ] [ Designated as safety issue: No ]
- Concordance of opinion between specialists (cardiologists,surgeon,non-interventional cardiologist) on number of coronary vessels with significant stenoses, revascularisation need and strategy, FFR data and angio assessment. [ Time Frame: N\A ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
-
Device: Radi pressure wire (pressure wire assessment)
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients referred for elective coronary angiography under a non-interventional cardiologist for the investigation of chest pain thought to be of cardiac origin.
- There is no requirement for a test demonstrating objective evidence of myocardial ischaemia because this study aims to recruit consecutive patients in real world current practice
- Written informed consent
- No participation in other studies
Exclusion Criteria:
- Previous coronary artery bypass graft surgery
- Acute coronary syndrome at presentation
- Diagnostic angiography or percutaneous coronary intervention within the previous 12 months
- Contraindication to adenosine
- Severe valve disease
- Creatinine >180
- Life threatening comorbidity
- Diagnostic angiogram showing "normal" coronary arteries defined as no coronary stenosis of >30% by visual estimate in any epicardial vessel of >2.25mm diameter
Contacts and Locations| Contact: Nick Curzen, BM(Hons) PhD FRCP | +44 (0)23 8079 4972 ext Direct line | nick.curzen@suht.swest.nhs.uk |
| Contact: Sue Kitt, BA(Hons) | +44 (0)23 8079 8538 ext Direct line | sue.kitt@suht.swest.nhs.uk |
| Ireland | |
| Dr Colm Hanratty | Recruiting |
| Belfast, Ireland, BT9 7AB | |
| Contact: Colm Hanratty colm.hanratty@belfasttrust.hscni.net | |
| Principal Investigator: Colm Hanratty | |
| United Kingdom | |
| Dr Alex Hobson | Not yet recruiting |
| Portsmouth, Hampshire, United Kingdom, PO6 3LY | |
| Contact: Alex Hobson alex.hobson@porthosp.nhs.uk | |
| Principal Investigator: Alex Hobson | |
| Dr Dan McKenzie | Not yet recruiting |
| Taunton, Somerset, United Kingdom, TA1 5DA | |
| Contact: Dan McKenzie dan.mckenzie@tst.nhs.uk | |
| Principal Investigator: Dan McKenzie | |
| Royal Sussex County Hospital | Completed |
| Brighton, United Kingdom, BN2 5BE | |
| Dr Kamal Chitkara | Not yet recruiting |
| Derby, United Kingdom, DE22 3NE | |
| Contact: Kamal Chitkara kamal.chitkara@nhs.net | |
| Principal Investigator: Kamal Chitkara | |
| West of Scotland Regional Heart & Lung Centre | Recruiting |
| Glasgow, United Kingdom, G81 4HX | |
| Contact: Keith Oldroyd keith.oldroyd@nhs.net | |
| Principal Investigator: Keith Oldroyd | |
| Dr Steve Wheatcroft | Recruiting |
| Leeds, United Kingdom, LS1 3EX | |
| Contact: Steve Wheatcroft S.B.Wheatcroft@leeds.ac.uk | |
| Principal Investigator: Steve Wheatcroft | |
| Freeman Hospital | Recruiting |
| Newcastle upon Tyne, United Kingdom, NE7 7DN | |
| Contact: Azfar Zaman Azfar.Zaman@nuth.nhs.uk | |
| Principal Investigator: Azfar Zaman | |
| John Radcliffe Hospital | Recruiting |
| Oxford, United Kingdom, OX3 9DU | |
| Contact: Adrian Banning adrian.banning@orh.nhs.uk | |
| Principal Investigator: Adrian Banning | |
| Southampton General Hospital | Recruiting |
| Southampton, United Kingdom, SO16 6YD | |
| Contact: Nick Curzen, BM (Hons) PhD FRCP nick.curzen@suht.swest.nhs.uk | |
| Principal Investigator: Nick Curzen, BM(Hons) PhD FRCP | |
| Principal Investigator: | Nick Curzen, BM(Hons) PhD FRCP | University Hospital Southampton NHS Foundation Trust. |
More Information
No publications provided
| Responsible Party: | Dr Nicholas Curzen, Consultant Cardiologist BM(Hons) PhD FRCP, Southampton University Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01070771 History of Changes |
| Other Study ID Numbers: | Version 3 dated 01/10/2009, 5327 |
| Study First Received: | February 17, 2010 |
| Last Updated: | July 22, 2011 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Keywords provided by University Hospital Southampton NHS Foundation Trust.:
|
Pressure wire Fractional flow reserve |
Additional relevant MeSH terms:
|
Chest Pain Coronary Artery Disease Myocardial Ischemia Coronary Disease Pain Signs and Symptoms |
Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013