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

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ClinicalTrials.gov Identifier: NCT01070771
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : November 11, 2015
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Coronary Artery Disease
Intervention Device: Radi pressure wire (pressure wire assessment)
Enrollment 203
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radi Pressure Wire
Hide Arm/Group Description Assessment of physiological significance of coronary artery narrowings by measurement of blood flow limitation across lesion.
Period Title: Overall Study
Started 203 [1]
Completed 200 [2]
Not Completed 3
Reason Not Completed
Adverse Event             2
Protocol Violation             1
[1]
September 2008
[2]
August 2012
Arm/Group Title Radi Pressure Wire
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants
64  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
51
  25.5%
Male
149
  74.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 200 participants
200
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Up until hospital discharge. Most cases were day cases but no specific data relating to length of stay collected.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radi Pressure Wire
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 200
Measure Type: Number
Unit of Measure: participants
Agreement with management plan 147
Change in management plan after FFR 53
Recommended medical treatment alone 72
Revascularisation was advised after FFR 9
Optimal medical therapy recommended after FFR 89
Recommended revascularisation after angiogram 25
Recommendation of PCI after angio assessment 90
Of the 90 FFR detected no significant stenosis 24
2.Secondary Outcome
Title 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.
Hide Description

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.
Time Frame Up to hospital discharge. Most were day case procedures but no specific data relating to discharge was collected.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RADI Pressure Wire
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 200
Measure Type: Number
Unit of Measure: participants
Number of vessels significantly changed after FFR 64
No significant CAD after angiography alone 81
Of the 81, significant FFR (<0.8) 18
No haemodynamically signifiacnt CAD after FFR 89
Of the 89, angio labelled as single vessel disease 24
of the 89, angio labelled as 2 vessel disease 1
of the 89, angio labelled as 3 vessel disease 1
significant 3 vessel disease at angio:negative FFR 1
Time Frame [Not Specified]
Adverse Event Reporting Description Only serious adverse events were collected
 
Arm/Group Title RADI Pressure Wire
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
RADI Pressure Wire
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
RADI Pressure Wire
Affected / at Risk (%) # Events
Total   3/200 (1.50%)    
Cardiac disorders   
Vessel occlusion † [1]  1/200 (0.50%)  1
Coronary artery dissection † [2]  1/200 (0.50%)  1
Ventricular fibrillation † [3]  1/200 (0.50%)  1
Vascular disorders   
Deep vein thrombosis † [4]  1/200 (0.50%)  1
†
Indicates events were collected by systematic assessment
[1]
In one patient, the operator crossed a tightly stenosed right coronary artery with the pressure wire but this vessel subsequently occluded, leading to emergency PCI and a troponin rise to 5.88mcg/L.
[2]
a second case, the pressure wire manipulation in the left anterior descending artery led to coronary artery dissection and the patient underwent emergency CABG surgery, which was subsequently complicated by a deep vein thrombosis.
[3]
In one patient there was an episode of ventricular fibrillation during FFR assessment of the RCA and the operator decided not to proceed to further measurements .
[4]
Patient underwent emergency CABG and subsequently went on to experience DVT
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RADI Pressure Wire
Affected / at Risk (%) # Events
Total   0/0    
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Nick Curzen
Organization: University Hospital Southampton NHS Foundation Trust
Phone: +44 023 80777222
EMail: nick.curzen@uhs.nhs.uk
Publications of Results:
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01070771    
Other Study ID Numbers: Version 3 dated 01/10/2009
5327 ( Registry Identifier: UK Clinical Research Network Portfolio )
First Submitted: February 17, 2010
First Posted: February 18, 2010
Results First Submitted: May 29, 2015
Results First Posted: November 11, 2015
Last Update Posted: May 22, 2019