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

This study has been completed.
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust. Identifier:
First received: February 17, 2010
Last updated: October 12, 2015
Last verified: October 2015

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 (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. ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]

    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.

Enrollment: 203
Study Start Date: June 2008
Study Completion Date: August 2012
Primary Completion Date: August 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


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
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 identifier: 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.
  More Information

Additional Information:
Responsible Party: University Hospital Southampton NHS Foundation Trust. Identifier: NCT01070771     History of Changes
Other Study ID Numbers: Version 3 dated 01/10/2009, 5327
Study First Received: February 17, 2010
Results First Received: May 29, 2015
Last Updated: October 12, 2015
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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Signs and Symptoms
Vascular Diseases processed this record on November 30, 2015