N/A
N=203
Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01070771 ↗Enrolled (actual)
203
Serious AEs
1.5%
Results posted
Nov 2015
Primary outcome: Primary: 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) — 147; 53; 72; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radi pressure wire (pressure wire assessment) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital Southampton NHS Foundation Trust
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
147; 53; 72; 9; 89; 25 | — |
| SECONDARY 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. |
64; 81; 18; 89; 24; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01070771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.