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)
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|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
|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.
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|