Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain? (RIPCORD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University Hospital Southampton NHS Foundation Trust..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier:
NCT01070771
First received: February 17, 2010
Last updated: July 22, 2011
Last verified: July 2011
  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?

Resource links provided by NLM:


Further study details as provided by University Hospital Southampton NHS Foundation Trust.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    Device: Radi pressure wire (pressure wire assessment)
    Intracoronary insertion of pressure wire at the time of diagnostic angiography.
    Other Name: Radi pressure wire.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070771

Contacts
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

Locations
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         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust.
Investigators
Principal Investigator: Nick Curzen, BM(Hons) PhD FRCP University Hospital Southampton NHS Foundation Trust.
  More Information

No publications provided by University Hospital Southampton NHS Foundation Trust.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 28, 2014