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

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. Identifier: NCT01070771
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief Summary:

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 or disease Intervention/treatment Phase
Coronary Artery Disease Device: Radi pressure wire (pressure wire assessment) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?
Study Start Date : June 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG) [ Time Frame: Up until hospital discharge. Most cases were day cases but no specific data relating to length of stay collected. ]
    This outcome measure was assessing agreement in the management plan (MP) derived from angiographic assessment alone compared to a MP derived from angiographic assessment plus the use of FFR data acquired at the time of angiography. The study assessed the proportion of cases in which the angiogram directed MP changed after FFR data were disclosed.

Secondary Outcome Measures :
  1. To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data. [ Time Frame: Up to hospital discharge. Most were day case procedures but no specific data relating to discharge was collected. ]

    This compared the number of vessels in which there was a discrepant result in relation to angiographically and FFR defined significance. Angiographic significance was visually assessed by operators whereas the pressure wire provided objective data as to a narrowing's significance: an FFR reading of <0.8 indicated a significant restriction in blood flow with a recommendation for revascularisation.

    The difference in indication for revascularisation of each major coronary artery was also judged according to angiogram alone compared with angiogram plus FFR dtaa.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01070771

Dr Colm Hanratty
Belfast, Ireland, BT9 7AB
United Kingdom
Dr Alex Hobson
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Dr Dan McKenzie
Taunton, Somerset, United Kingdom, TA1 5DA
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
Dr Kamal Chitkara
Derby, United Kingdom, DE22 3NE
West of Scotland Regional Heart & Lung Centre
Glasgow, United Kingdom, G81 4HX
Dr Steve Wheatcroft
Leeds, United Kingdom, LS1 3EX
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Principal Investigator: Nick Curzen, BM(Hons) PhD FRCP University Hospital Southampton NHS Foundation Trust

Additional Information:
Publications of Results:
Responsible Party: University Hospital Southampton NHS Foundation Trust Identifier: NCT01070771     History of Changes
Other Study ID Numbers: Version 3 dated 01/10/2009
5327 ( Registry Identifier: UK Clinical Research Network Portfolio )
First Posted: February 18, 2010    Key Record Dates
Results First Posted: November 11, 2015
Last Update Posted: November 11, 2015
Last Verified: October 2015

Keywords provided by University Hospital Southampton NHS Foundation Trust:
Pressure wire
Fractional flow reserve

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Chest Pain
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms