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
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Tracking Information | ||||
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First Submitted Date ICMJE | February 17, 2010 | |||
First Posted Date ICMJE | February 18, 2010 | |||
Results First Submitted Date ICMJE | May 29, 2015 | |||
Results First Posted Date ICMJE | November 11, 2015 | |||
Last Update Posted Date | May 22, 2019 | |||
Study Start Date ICMJE | June 2008 | |||
Actual Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Estimation of number of cases where FFR data results in a change in the management strategy the revascularisation strategy (number of vessel requiring treatment and/or PCI vs medical vs CABG) [ Time Frame: Up until hospital discharge ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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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Original Secondary Outcome Measures ICMJE |
Concordance of opinion between specialists (cardiologists,surgeon,non-interventional cardiologist) on number of coronary vessels with significant stenoses, revascularisation need and strategy, FFR data and angio assessment. [ Time Frame: N\A ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain? | |||
Official Title ICMJE | Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain? | |||
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. |
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Detailed Description | The choice of management in an individual patient is determined largely by the presence and distribution of significant coronary narrowings. Usually, this significance is judged by the visual estimation of a narrowing on an angiogram. However, although this is the standard way of assessing coronary narrowings, it is now widely published that pressure wire measurements are more accurate because they assess the true physiological consequences of the narrowing. Interventional cardiologists now frequently use Fractional Flow Reserve (FFR) measurements to help them decide if arteries require stenting.The hypothesis for this study is that routine measurement of FFR in the main coronary arteries could provide diagnostic information above and beyond that obtained by an angiogram alone. This additional information may well then affect the choice of management in a proportion of these patients. For example, a narrowing considered to be significant angiographically may be shown to be insignificant with FFR, or vice versa. Background Coronary artery disease (CAD) is a major cause of morbidity and mortality in the United Kingdom. It accounts for approximately half of all cardiovascular related deaths annually and, according to statistics from the British Heart Foundation, CAD related expenditure was £3,500 million in 2003 alone. Much effort has been placed on improving methods that detect and assess the severity of CAD and facilitate more rapid and appropriate management for CAD patients. Once diagnosed, CAD may be treated in 3 ways: (1)tablets alone, (2)tablets plus angioplasty with stents or (3) tablets plus coronary artery bypass graft surgery (CABG). The method of choice depends primarily on the extent and severity of disease at the time of coronary angiography. Coronary angiography is the current conventional method for the diagnosis of CAD and is used in the assessment of disease severity. For the angiographic procedure,vascular access is secured via the femoral artery or radial artery route and a dye is injected into the coronary artery blood vessels. The progress of the dye through the coronary blood vessels provides a visual assessment of where narrowings are present in the coronary arteries. Where there is thought to be significant flow obstruction, particularly in symptomatic patients, one of the above three treatments will be offered. While coronary angiography has revolutionised the management of CAD, the procedure is not without limitation. The purely visual assessment of disease severity with coronary angiography is subjective and patient management can depend on the cardiologist reviewing the films. Many such narrowings can be graded 'moderate' severity and deciding whether these are of haemodynamic significance is notoriously difficult by angiography alone. In recent years, the Radi pressure wire has been shown to provide accurate physiological haemodynamic data about coronary narrowings. Furthermore, the FFR measurement derived predicts clinical outcome, hence giving a 'cut-off' measurement for severity of disease that correlates with the requirement for revascularisation with either stents or surgery. Thus FFR is now frequently used in clinical practice by interventional cardiologists to decide if narrowings require treatment. However, the majority of diagnostic angiography in the UK is performed by non-interventional cardiologists who do not currently have access to the pressure wire technology. In this study, we speculate that if we measure the FFR routinely in all the main coronary arteries of patients undergoing coronary angiography the FFR data obtained may affect the angiogram-derived management of some patients in terms of the choice of tablets/stents/CABG. For example, some narrowings that look significant angiographically may not be haemodynamically important by FFR and vice versa. Clearly this could make a difference between revascularising a patient or not. Research Aims To evaluate:
Methods and Design The study will recruit 200 patients listed for diagnostic coronary angiography performed by a non-interventional cardiologist. Methodology 1: In Catheter Laboratory
Table 1
Analysis PRIMARY ENDPOINT Estimation of number of cases where FFR data results in a change in the management strategy the revascularisation strategy (number of vessel requiring treatment and/or PCI vs medical vs CABG) Potential Clinical Value If this study proves its hypothesis, it will suggest that coronary angiography would be better supported by routine pressure wire assessment in order to tailor revascularisation strategies for individual patients more accurately. The result of this study will carry important clinical implications if the study hypothesis is proven.... not least in terms of potential patient benefit. The current widely held practice of diagnostic test followed by either (i) referral for revascularisation or, (ii) in the case of equivocal angiographic results, referral for stress imaging to look for objective evidence of ischaemia followed by referral for revascularisation where positive could be rendered obsolete by diagnostic angiography performed by interventional cardiologists with FFR availability and the ability to perform PCI at the same sitting where appropriate. The study may generate the hypothesis that such routine FFR measurement will not only be of benefit to patients but also be cost-effective if there would have been fewer interventions overall (ie less CABG + PCI) or fewer expensive interventions (i.e. less CABG versus PCI)? |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Coronary Artery Disease | |||
Intervention ICMJE | Device: Radi pressure wire (pressure wire assessment)
Intracoronary insertion of pressure wire at the time of diagnostic angiography.
Other Name: Radi pressure wire.
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Study Arms ICMJE | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
203 | |||
Original Estimated Enrollment ICMJE |
200 | |||
Actual Study Completion Date ICMJE | August 2012 | |||
Actual Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Ireland, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01070771 | |||
Other Study ID Numbers ICMJE | Version 3 dated 01/10/2009 5327 ( Registry Identifier: UK Clinical Research Network Portfolio ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | University Hospital Southampton NHS Foundation Trust | |||
Original Responsible Party | Dr Nicholas Curzen, Consultant Cardiologist BM(Hons) PhD FRCP, Southampton University Hospitals NHS Trust | |||
Current Study Sponsor ICMJE | University Hospital Southampton NHS Foundation Trust | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University Hospital Southampton NHS Foundation Trust | |||
Verification Date | October 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |