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 : November 11, 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 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)|
|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|
- Device: Radi pressure wire (pressure wire assessment)
Intracoronary insertion of pressure wire at the time of diagnostic angiography.Other Name: Radi pressure wire.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01070771
|Dr Colm Hanratty|
|Belfast, Ireland, BT9 7AB|
|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|
|Newcastle upon Tyne, United Kingdom, NE7 7DN|
|John Radcliffe Hospital|
|Oxford, United Kingdom, OX3 9DU|
|Southampton General Hospital|
|Southampton, United Kingdom, SO16 6YD|
|Principal Investigator:||Nick Curzen, BM(Hons) PhD FRCP||University Hospital Southampton NHS Foundation Trust|