Chest PainRIPCORD 2NCT02892903

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?

A study testing Routine Measurement of FFR in people with Chest Pain and Stable Angina, run by University Hospital Southampton NHS Foundation Trust at 17 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

A randomised controlled trial to compare two strategies for the investigation of coronary artery disease at the time of angiography. Patients will be randomised to conventional angiography or additional, routine pressure wire assessment - measuring fractional flow reserve (FFR) - in all main vessels judged as being of… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chest Pain, Stable Angina, Acute Coronary Syndrome
What is being tested?: Routine Measurement of FFR
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,100 participants
Where: 17 sitesUnited Kingdom
Study dates: Sep 2016to Mar 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Show all 33Show fewer

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)

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United Kingdom17 sites

Queen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH
Royal Blackburn Teaching Hospital - East Lancashire Hospitals NHS Trust
Blackburn, Lancashire, BB2 3HH
Royal Bournemouth Hospital - The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, Dorset, BH7 7DW
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, BN2 5BE
Bristol Heart Institute - University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8HW
Golden Jubilee National Hospital
Glasgow, Scotland, G81 4DY
Castle Hill Hospital - Hull and East Yorkshire Hospitals NHS Trust
Hull, Yorkshire, HU16 5JQ
Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, LS1 3EX
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, Merseyside, L14 3PE
King's Mill Hospital - Sherwood Forest Hospitals NHS Foundation Trust
Mansfield, Nottinghamshire, NG17 4JL
Freeman Hospital - Newcastle Hospitals
Newcastle upon Tyne, Northumberland, NE7 7DN
City Hospital - Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG5 1PB
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY
Northern General Hospital - Sheffield Teaching Hospitals
Sheffield, South Yorkshire, S5 7AU
Southampton General Hospital - University Hospitals Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
Royal Stoke University Hospital - University Hospitals of North Midlands
Stoke-on-Trent, Staffordshire, ST4 6QG
Pinderfields Hospital - The Mid Yorkshire Hospitals NHS Trust
Wakefield, West Yorkshire, WF1 4DG

Other trials in United Kingdom

About this study

Official title: A Randomised Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease.

Read the detailed description

The study will recruit patients undergoing angiography for the investigation of stable angina or for the assessment of a recent, but stabilised, non-ST elevation acute coronary syndrome event. Eligible patients who provide written informed consent will be randomised to conventional angiography or additional, routine pressure wire assessment - measuring fractional flow reserve (FFR) - in all main vessels judged as being of sufficient vessel calibre to allow percutaneous coronary intervention (PCI) (experimental arm). The study pragmatic design allows investigators to conduct all diagnostic and therapeutic management in accordance with prevailing best practice patterns. Study outcome measures will examine resource utilisation, patient reported quality of life and clinical events at 1 year.

Conditions: Chest Pain, Stable Angina, Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Being tested: Routine Measurement of FFR
Keywords: Fractional flow reserve (FFR), Pressure wire (PW), Coronary angiography
Medical subject headings: Chest Pain, Angina, Stable, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Routine Measurement of FFRDevice
Also called Pressure wire assessment
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

Study groups in NCT02892903
Study group	Role	What they receive
Conventional angiography	No intervention	Routine angiography will be performed according to local best practice
Routine Measurement of FFR	Experimental	Additional investigation with the measurement of FFR in all major vessels Receives: Device: Routine Measurement of FFR

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Economic Outcome Measure
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.
Measured: One year
Primary Quality of Life Outcome Measure
Patient reported quality of life at one year using the EQ-5D health questionnaire.
Measured: One year

Secondary outcomes (10)

Management strategy information
- Proportion of vessels deemed to demonstrate flow-limiting disease and targeted for revascularisation in the declared initial management strategy.
Measured: Reported once: Single declaration at index procedure after randomisation
Management strategy information
- 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.
Measured: Reported once: Single declaration at index procedure after randomisation
Angina symptoms
- Angina symptoms as reported by the research team after the 12 month contact, described by Canadian Cardiovascular Society Grade.
Measured: One year
Angina symptoms
- Angina symptoms as reported by the patient with private completion of a screening form at 12 months, described by Canadian Cardiovascular Society Grade.
Measured: One year
All-cause mortality
Measured: One year
Number of hospitalisation events
Measured: One year
Total hospital days
Measured: One year
Hospitalisation events
Hospitalisation events coded as cerebro-vascular accident (CVA).
Measured: One year
Hospitalisation events
Hospitalisation events coded as myocardial infarction.
Measured: One year
Hospitalisation events
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.
Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Mar 2020

First posted8 Sep 2016 (estimated)
Study startSep 2016
Primary completionDec 2019 (estimated)
Study completionMar 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Chest PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02892903
Sponsor's protocol ID: RHM CAR0498
Acronym: RIPCORD 2
Status last verified: Aug 2019
First submitted: 6 Jul 2016
Last updated: 12 Aug 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Zir LM, Miller SW, Dinsmore RE, Gilbert JP, Harthorne JW. Interobserver variability in coronary angiography. Circulation. 1976 Apr;53(4):627-32. doi: 10.1161/01.cir.53.4.627.
PubMed 1253383
White CW, Wright CB, Doty DB, Hiratza LF, Eastham CL, Harrison DG, Marcus ML. Does visual interpretation of the coronary arteriogram predict the physiologic importance of a coronary stenosis? N Engl J Med. 1984 Mar 29;310(13):819-24. doi: 10.1056/NEJM198403293101304.
PubMed 6700670
De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22. doi: 10.1161/01.cir.89.3.1013.
PubMed 8124786
Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
PubMed 8637515
Berger A, Botman KJ, MacCarthy PA, Wijns W, Bartunek J, Heyndrickx GR, Pijls NH, De Bruyne B. Long-term clinical outcome after fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. J Am Coll Cardiol. 2005 Aug 2;46(3):438-42. doi: 10.1016/j.jacc.2005.04.041.
PubMed 16053955
Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
PubMed 19144937
Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.
PubMed 17531660
Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
PubMed 20537493
De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
PubMed 22924638
Longman K, Curzen N. Should ischemia be the main target in selecting a percutaneous coronary intervention strategy? Expert Rev Cardiovasc Ther. 2013 Aug;11(8):1051-9. doi: 10.1586/14779072.2013.814856.
PubMed 23984928
Toth G, Hamilos M, Pyxaras S, Mangiacapra F, Nelis O, De Vroey F, Di Serafino L, Muller O, Van Mieghem C, Wyffels E, Heyndrickx GR, Bartunek J, Vanderheyden M, Barbato E, Wijns W, De Bruyne B. Evolving concepts of angiogram: fractional flow reserve discordances in 4000 coronary stenoses. Eur Heart J. 2014 Oct 21;35(40):2831-8. doi: 10.1093/eurheartj/ehu094. Epub 2014 Mar 18.
PubMed 24644308
Curzen N, Rana O, Nicholas Z, Golledge P, Zaman A, Oldroyd K, Hanratty C, Banning A, Wheatcroft S, Hobson A, Chitkara K, Hildick-Smith D, McKenzie D, Calver A, Dimitrov BD, Corbett S. Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain?: the RIPCORD study. Circ Cardiovasc Interv. 2014 Apr;7(2):248-55. doi: 10.1161/CIRCINTERVENTIONS.113.000978. Epub 2014 Mar 18.
PubMed 24642999
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction. Glob Heart. 2012 Dec;7(4):275-95. doi: 10.1016/j.gheart.2012.08.001. Epub 2012 Sep 26. No abstract available.
PubMed 25689940
Weintraub WS, Mahoney EM, Zhang Z, Chu H, Hutton J, Buxton M, Booth J, Nugara F, Stables RH, Dooley P, Collinson J, Stuteville M, Delahunty N, Wright A, Flather MD, De Cock E. One year comparison of costs of coronary surgery versus percutaneous coronary intervention in the stent or surgery trial. Heart. 2004 Jul;90(7):782-8. doi: 10.1136/hrt.2003.015057.
PubMed 15201249
Zhang Z, Mahoney EM, Stables RH, Booth J, Nugara F, Spertus JA, Weintraub WS. Disease-specific health status after stent-assisted percutaneous coronary intervention and coronary artery bypass surgery: one-year results from the Stent or Surgery trial. Circulation. 2003 Oct 7;108(14):1694-700. doi: 10.1161/01.CIR.0000087600.83707.FD. Epub 2003 Sep 15.
PubMed 12975252

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease.
ClinicalTrials.gov ID: NCT02892903
Acronym / sponsor ID: RIPCORD 2 / RHM CAR0498
Conditions: Chest Pain, Stable Angina, Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Keywords: Fractional flow reserve (FFR), Pressure wire (PW), Coronary angiography
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,100 participants (actual)
Lead sponsor: University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
Collaborators: Liverpool Heart and Chest Hospital NHS Foundation Trust
Study start: Sep 2016
Primary completion: Dec 2019 (estimated)
Study completion: Mar 2020 (estimated)
First posted: 8 Sep 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Conventional angiography	No intervention	–Routine angiography will be performed according to local best practice
Routine Measurement of FFR	Experimental	Device: Routine Measurement of FFRAdditional investigation with the measurement of FFR in all major vessels

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (33 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Routine Measurement of FFRAlso: Pressure wire assessmentFFR 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	Device	Routine Measurement of FFR

Primary outcome

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.

10 secondary outcomes

Management strategy information
Time frame: Reported once: Single declaration at index procedure after randomisation
Management strategy information
Time frame: Reported once: Single declaration at index procedure after randomisation
Angina symptoms
Time frame: One year
Angina symptoms
Time frame: One year
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
Time frame: One year
Hospitalisation events
Time frame: One year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Background: PubMed 1253383Zir LM, Miller SW, Dinsmore RE, Gilbert JP, Harthorne JW. Interobserver variability in coronary angiography. Circulation. 1976 Apr;53(4):627-32. doi: 10.1161/01.cir.53.4.627.
Background: PubMed 6700670White CW, Wright CB, Doty DB, Hiratza LF, Eastham CL, Harrison DG, Marcus ML. Does visual interpretation of the coronary arteriogram predict the physiologic importance of a coronary stenosis? N Engl J Med. 1984 Mar 29;310(13):819-24. doi: 10.1056/NEJM198403293101304.
Background: PubMed 8124786De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22. doi: 10.1161/01.cir.89.3.1013.
Background: PubMed 8637515Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
Background: PubMed 16053955Berger A, Botman KJ, MacCarthy PA, Wijns W, Bartunek J, Heyndrickx GR, Pijls NH, De Bruyne B. Long-term clinical outcome after fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. J Am Coll Cardiol. 2005 Aug 2;46(3):438-42. doi: 10.1016/j.jacc.2005.04.041.
Background: PubMed 19144937Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
Background: PubMed 17531660Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW, van't Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B. Percutaneous coronary intervention of functionally nonsignificant stenosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol. 2007 May 29;49(21):2105-11. doi: 10.1016/j.jacc.2007.01.087. Epub 2007 May 17.
Background: PubMed 20537493Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
Background: PubMed 22924638De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.
Background: PubMed 23984928Longman K, Curzen N. Should ischemia be the main target in selecting a percutaneous coronary intervention strategy? Expert Rev Cardiovasc Ther. 2013 Aug;11(8):1051-9. doi: 10.1586/14779072.2013.814856.
Background: PubMed 24644308Toth G, Hamilos M, Pyxaras S, Mangiacapra F, Nelis O, De Vroey F, Di Serafino L, Muller O, Van Mieghem C, Wyffels E, Heyndrickx GR, Bartunek J, Vanderheyden M, Barbato E, Wijns W, De Bruyne B. Evolving concepts of angiogram: fractional flow reserve discordances in 4000 coronary stenoses. Eur Heart J. 2014 Oct 21;35(40):2831-8. doi: 10.1093/eurheartj/ehu094. Epub 2014 Mar 18.
Background: PubMed 24642999Curzen N, Rana O, Nicholas Z, Golledge P, Zaman A, Oldroyd K, Hanratty C, Banning A, Wheatcroft S, Hobson A, Chitkara K, Hildick-Smith D, McKenzie D, Calver A, Dimitrov BD, Corbett S. Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain?: the RIPCORD study. Circ Cardiovasc Interv. 2014 Apr;7(2):248-55. doi: 10.1161/CIRCINTERVENTIONS.113.000978. Epub 2014 Mar 18.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicholas Curzen, BM PhD FRCP principal investigator

University Hospital Southampton NHS Foundation Trust

Rod H Stables, MA, DM, BM BCH, FRCP principal investigator

Liverpool Heart and Chest Hospital NHS Foundation Trust

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Routine Measurement of FFR in people with Chest Pain and Stable Angina, run by University Hospital Southampton NHS Foundation Trust at 17 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Economic Outcome Measure (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02892903, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.