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

NCT01070771 | Completed Results DMC

• 2 other identifiers: Version 3 dated 01/10/20095327
• Study Type: interventional
• Target: 203
• Locations: 2 countries
• Sites: 10

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.

Conditions

Coronary Artery Disease

Keywords

Pressure wire; Fractional flow reserve

Outcome Measures

Primary Outcomes (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)

  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.

  Up until hospital discharge. Most cases were day cases but no specific data relating to length of stay collected.

Secondary Outcomes (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.

  Up to hospital discharge. Most were day case procedures but no specific data relating to discharge was collected.

Interventions

Radi pressure wire (pressure wire assessment) DEVICE

Intracoronary insertion of pressure wire at the time of diagnostic angiography.

Also known as: Radi pressure wire.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (10)

Dr Colm Hanratty

Belfast, BT9 7AB, Ireland

Location

Dr Alex Hobson

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Dr Dan McKenzie

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Dr Kamal Chitkara

Derby, DE22 3NE, United Kingdom

Location

West of Scotland Regional Heart & Lung Centre

Glasgow, G81 4HX, United Kingdom

Location

Dr Steve Wheatcroft

Leeds, LS1 3EX, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (3)

• Curzen N, Rana O, Nicholas Z, Golledge P, Zaman A, Oldroyd K, Hanratty C, Banning A, Wheatcroft S, Hobson A, Chitkara K, Hildick-Smith D, McKenzie D, Calver A, Dimitrov BD, Corbett S. Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain?: the RIPCORD study. Circ Cardiovasc Interv. 2014 Apr;7(2):248-55. doi: 10.1161/CIRCINTERVENTIONS.113.000978. Epub 2014 Mar 18.

  PMID: 24642999 RESULT

• Bashar HAB, Saunders A, Alaour B, Gerontitis D, Hinton J, Karamanou D, Kechagioglou G, Olsen S, Onwordi E, Pope M, Zingale A, Nicholas Z, Golledge P, Escaned J, Ali Z, Curzen N. Systematic coronary physiology improves level of agreement in diagnostic coronary angiography. Open Heart. 2023 May;10(1):e002258. doi: 10.1136/openhrt-2023-002258.

  PMID: 37130658 DERIVED

• Stables RH, Mullen LJ, Elguindy M, Nicholas Z, Aboul-Enien YH, Kemp I, O'Kane P, Hobson A, Johnson TW, Khan SQ, Wheatcroft SB, Garg S, Zaman AG, Mamas MA, Nolan J, Jadhav S, Berry C, Watkins S, Hildick-Smith D, Gunn J, Conway D, Hoye A, Fazal IA, Hanratty CG, De Bruyne B, Curzen N. Routine Pressure Wire Assessment Versus Conventional Angiography in the Management of Patients With Coronary Artery Disease: The RIPCORD 2 Trial. Circulation. 2022 Aug 30;146(9):687-698. doi: 10.1161/CIRCULATIONAHA.121.057793. Epub 2022 Aug 10.

  PMID: 35946404 DERIVED

Related Links

• Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?: The RIPCORD Study

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Professor Nick Curzen
• Organization: University Hospital Southampton NHS Foundation Trust

nick.curzen@uhs.nhs.uk

+44 023 80777222

Study Officials

• Nick Curzen, BM(Hons) PhD FRCP

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: June 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 22, 2019
• Results First Posted: November 11, 2015

Record last verified: 2015-10

Locations

GB (9); IE (1)