In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? (RIPCORD 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02892903|
Recruitment Status : Unknown
Verified August 2019 by University Hospital Southampton NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : September 8, 2016
Last Update Posted : August 12, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain Stable Angina Acute Coronary Syndrome Non ST Segment Elevation Acute Coronary Syndrome||Device: Routine Measurement of FFR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease.|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
No Intervention: Conventional angiography
Routine angiography will be performed according to local best practice
Experimental: Routine Measurement of FFR
Additional investigation with the measurement of FFR in all major vessels
Device: Routine Measurement of FFR
FFR measurement will be performed in all major vessels with normal (TIMI 3) flow. Occluded vessels and vessels with TIMI flow <3 will not be examined but will be 'awarded' an FFR value of 0.5
Other Name: Pressure wire assessment
- Primary Economic Outcome Measure [ Time Frame: One year ]Resource utilisation as determined by hospital care costs at one year; All hospital admissions will be tracked using national hospital episode statistics; the cost of each episode will be derived from a cost model using standard UK tariffs. This analysis will compare the mean (or median) of the total hospital costs recorded for each patient over the 12 month follow-up period.
- Primary Quality of Life Outcome Measure [ Time Frame: One year ]Patient reported quality of life at one year using the EQ-5D health questionnaire.
- Management strategy information [ Time Frame: Reported once: Single declaration at index procedure after randomisation ]· Proportion of vessels deemed to demonstrate flow-limiting disease and targeted for revascularisation in the declared initial management strategy.
- Management strategy information [ Time Frame: Reported once: Single declaration at index procedure after randomisation ]· Proportion of patients scheduled for management with medical therapy, percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in the declared initial management strategy.
- Angina symptoms [ Time Frame: One year ]• Angina symptoms as reported by the research team after the 12 month contact, described by Canadian Cardiovascular Society Grade.
- Angina symptoms [ Time Frame: One year ]• Angina symptoms as reported by the patient with private completion of a screening form at 12 months, described by Canadian Cardiovascular Society Grade.
- All-cause mortality [ Time Frame: One year ]
- Number of hospitalisation events [ Time Frame: One year ]
- Total hospital days [ Time Frame: One year ]
- Hospitalisation events [ Time Frame: One year ]Hospitalisation events coded as cerebro-vascular accident (CVA).
- Hospitalisation events [ Time Frame: One year ]Hospitalisation events coded as myocardial infarction.
- Hospitalisation events [ Time Frame: One year ]
Hospitalisation events coded as Coronary revascularisation. This analysis will involve a pre-specified subgroup analysis of:
- Planned revascularisation - if declared as the index strategy.
- All additional revascularisation events.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
· Inclusion criteria
o Outline Initial Inclusion Criteria (before entry to cath lab):
Patient scheduled for coronary angiography for the:
- Elective investigation of known or suspected coronary artery disease OR
Urgent investigation of a recent but stabilised, non-ST elevation acute coronary syndrome event
o Outline Angiographic Inclusion Criterion (after angiography):
- Presence of significant coronary disease defined as:
Any stenosis >30% reduction in luminal diameter, by visual estimate, in at least one vessel (main or branch) of sufficient calibre to permit the potential performance of PCI - approximately 2.25 mm diameter.
Key Exclusion Criteria
Screening phase exclusion criteria:
- ≤ 18 years of age
- Previous enrolment in this trial
- Currently enrolled into another study unless co-enrolment approved by Chief Investigator (CI) and the clinical trials unit (CTU)
- Inability to provide informed consent
- Residence outside the United Kingdom (UK) or other issues limiting the ability to secure clinical follow-up data to one year
- Non-cardiac pathology that may limit survival in the next year
- Clear contraindication to potential future management with CABG or PCI (patients should be a potential candidate for medical therapy or revascularisation with either PCI or surgery)
- Heart valve disease of sufficient import to consider valve replacement or other intervention as part of an index management strategy
- Hypertrophic cardiomyopathy
- Previous coronary artery surgery of any type
- Known chronic renal impairment with a current estimated glomerular filtration rate (eGFR) of < 45
- Anaemia with a current measured haemoglobin of < 100
- Angiography performed in the context of an ST elevation myocardial infarction event
- Any patient who at the time of planned angiography manifests haemodynamic instability, or recurrent sustained ventricular arrhythmia, or Mobitz type II or complete heart block
- Any patient who at the time of planned angiography manifests unstable chest pain symptoms at rest or has required the continuing use of intravenous nitrates or regular opioid analgesia to control symptoms
- Continuing use of intravenous glycoprotein 2b/3a (GP2b3a) agents before entry to the catheterisation laboratory
- Known intolerance, hypersensitivity or contraindication to adenosine - including significant reversible airways disease
- Additional investigations planned (or deemed likely to be required) for the assessment of myocardial ischaemia or viability. Examples of proposed tests that would constitute an exclusion criterion would include, but are not limited to, exercise tolerance testing, stress echocardiography, cardiac MRI viability or perfusion scanning or nuclear myocardial perfusion scanning.
- Active bleeding at the time of planned index angiography
- Pregnant women
Angiographic phase exclusion criteria:
- Single vessel occlusive coronary disease (TIMI flow <3) as sole disease
Patient not suitable for the immediate performance of a pressure wire assessment of all major vessels for any reason, for example:
- Patient discomfort
- Change in the clinical condition or complication of angiography requiring termination of the procedure or immediate intervention
- Significant use of radiographic contrast or X-Ray exposure during the initial angiography
- Inadequate angiographic images or failure to intubate any of the coronary vessels
- Aorto-ostial disease that would preclude accurate assessment of FFR
- Insufficient laboratory time
- Uncertain availability of key clinical and trial staff
- PW use in coronaries declared unsafe (e.g. tight or long disease)
- PW use in coronaries declared unsuitable (e.g. distal disease or complete cross-filling)
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): NCT02892903
|Principal Investigator:||Nicholas Curzen, BM PhD FRCP||University Hospital Southampton NHS Foundation Trust|
|Principal Investigator:||Rod H Stables, MA, DM, BM BCH, FRCP||Liverpool Heart and Chest Hospital NHS Foundation Trust|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||University Hospital Southampton NHS Foundation Trust|
|Other Study ID Numbers:||
|First Posted:||September 8, 2016 Key Record Dates|
|Last Update Posted:||August 12, 2019|
|Last Verified:||August 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Fractional flow reserve (FFR)
Pressure wire (PW)
Coronary Artery Disease
Acute Coronary Syndrome
Arterial Occlusive Diseases