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A developmental clinical study of management guided by coronary angiography combined with fractional flow reserve (FFR) measurement versus management guided by coronary angiography alone (standard care) in patients with Non-ST Elevation Myocardial Infarction
ISRCTN ISRCTN97489534
DOI 10.1186/ISRCTN97489534
ClinicalTrials.gov identifier
EudraCT number
Public title A developmental clinical study of management guided by coronary angiography combined with fractional flow reserve (FFR) measurement versus management guided by coronary angiography alone (standard care) in patients with Non-ST Elevation Myocardial Infarction
Scientific title Fractional flow reserve versus Angiographically guided Management to Optimise outcomes in Unstable coronary Syndromes: a developmental clinical study of management guided by coronary angiography combined with fractional flow reserve (FFR) measurement versus management guided by coronary angiography alone (standard care) in patients with Non-ST Elevation MI
Acronym FAMOUS NSTEMI
Serial number at source 11254
Study hypothesis Do treatment decisions correspond to FFR values in individual coronary arteries in patients with recent non-ST elevation myocardial infarction (NSTEMI)?
More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11254
Lay summary Lay summary under review 3
Ethics approval The West Glasgow Hospital Ethics Committee First MREC approval date 01/03/2011, ref:11/S0703/6
Study design Randomised; Interventional; Design type: Treatment
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Coronary Artery
Participants - inclusion criteria 1. NSTEMI with at least one coronary artery disease (CAD) risk factor (e.g. diabetes, age > 65 years, prior CAD, prior peripheral vascular disease, hypertension, hyperlipidaemia, family history of CAD). These criteria were drawn from a recent clinical trial in NSTEMI (TIMACS, NEJM 2009)
2. Electrocardiogram (ECG) changes consistent with myocardial ischaemia (e.g. T wave
inversion, ST segment depression; new or established)
3. Ischaemic symptoms (e.g. chest pain) for at least 10 minutes
4. Invasive management scheduled within 10 days of admission and ideally performed within 72 h or admission (according to contemporary published guidelines)
Participants - exclusion criteria 1. Ongoing ischaemic symptoms (i.e. chest pain)
2. Cardiogenic shock or haemodynamic instability
3. Angiographic exclusion: reduced coronary flow (ie < TIMI grade III), highly tortuous or calcified arteries, left main stenosis >75% angiographically (ie consistent with severe left main disease
4. Life expectancy of < 1 year
5. Myocardial infarction (MI) with persistent ST elevation
6. Intolerance to antiplatelet drugs
7. Unsuitable for either percuataneous coronary intervention (PCI) or coronary artery bypass graft (CABG) on clinical or angiographic grounds
8. Coronary artery disease < 50% reference vessel diameter
9. Noncoronary cardiac surgery (e.g. concomitant valve repair or replacement)
10. Inability to give informed consent
Anticipated start date 21/10/2011
Anticipated end date 25/12/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned Sample Size: 350; UK Sample Size: 350
Interventions The coronary pressure wire will be passed into each coronary artery that the cardiologist feels to have a stenosis >=50% and would be eligible for revascularisation (PCI or CABG). FFR will be collected during coronary hyperaemia during systemic intravenous infusion of adenosine, according to our standard cath lab NHS protocol (140 mg/kg/min)). FFR results will be made available in the ‘FFR group’ by the Physiologist in the cath lab but not in the ‘usual care’ group.

FFR Group: In this group, doctors will have the FFR result available and can use this result to influence their treatment decisions as appropriate.

Usual care group: Patients in this group will receive current best practice which involves visual assessment of the coronary angiogram with treatment decisions made in the usual way according to standard care.
Primary outcome measure(s) 1. The between-group difference in the proportion of patients allocated to medical management compared to revascularisation. The patients will be followed up every 6 months until the completion of the study (approx 2 years)
2. Assessing the composite of all cause death/myocardial infarction (MI)/coronary artery bypass graft (CABG)/Heart Failure/stroke either in the index admission or through rehospitalisation
Secondary outcome measure(s) 1. The rate of discordance between FFR and visual assessment of coronary stenosis severity.
2. Receiver operating curve (ROC) values for FFR and subsequent adverse events.
3. Health-care costs associated with the index hospitalisation (or subsequent revascularisation)
4. Difference in QoL between each group at 12 months
5. Relationship between FFR results and health outcomes in the longer term
Sources of funding British Heart Foundation (BHF) (UK) (Grant Codes: PG/11/55/28999)
Trial website
Publications
Contact name Ms  Joanne  Kelly
  Address Clinical Governance and Risk Management Development Unit (CGRMDU)
Beardmore Street
  City/town Clydebank
  Zip/Postcode G81 4HX
  Country United Kingdom
  Email Joanne.kelly@gjnh.scot.nhs.uk
Sponsor National Waiting Times Centre Board (UK)
  Address Clinical Governance and Risk Management Development Unit (CGRMDU)
Beardmore Street
  City/town Clydebank
  Zip/Postcode G81 4HX
  Country United Kingdom
Date applied 16/11/2011
Last edited 02/08/2012
Date ISRCTN assigned 13/01/2012
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