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 | https://doi.org/10.1186/ISRCTN97489534 |
| ClinicalTrials.gov number | NCT01764334 |
| Secondary identifying numbers | 11254 |
- Submission date
- 16/11/2011
- Registration date
- 13/01/2012
- Last edited
- 04/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Heart artery fractional flow reserve (FFR) is the pressure drop across a narrowed coronary artery. FFR is measured with a coronary 'pressure wire'. The pressure wire is approved and routinely used in angina patients but it is not used routinely in patients with recent heart attack because of a lack of evidence. We think that use of the pressure wire in patients with recent heart attack could alter and improve treatment decisions. To demonstrate whether this could be the case a large study would be needed. However, before such a study could be done, a 'developmental' study is needed first in order to gather 'pilot' information about whether or not the pressure wire might be useful.
Who can participate?
Heart attack patients having coronary angiography/angioplasty.
What does the study involve?
Following informed consent and angiography, participants will be randomly assigned to either the FFR-guided group or the angiography-guided (usual care) group. The pressure wire will be used to give an FFR measurement across all coronary narrowings at least 30% narrow, as clinically appropriate. The pressure wire will be used in all patients. The FFR value will be disclosed in the FFR group but not in the usual care group. Doctors in the FFR group will therefore have an FFR result which they may or may not choose to guide decision-making, while clinical decisions will be made in the normal way in the usual care patients. Follow-up will be for at least 6 months.
What are the possible benefits and risks of participating?
Participants will not benefit directly from taking part but we will obtain useful information on whether or not FFR measurement is useful and appropriate in heart attack patients. Participants will be supporting research to find new ways to assess and manage patients with coronary artery disease. Adenosine is used for FFR measurement. Adenosine can cause a feeling of chest tightness but this feeling only lasts during the time the adenosine is being given. Otherwise, adenosine is well tolerated. Pressure measurement usually means some extra angiogram pictures in order to position the coronary wire. This means you would receive a small additional amount of radiation which should not be harmful to you. The extra dose will be generally equivalent to a couple of x-rays of your lower back for each artery to be assessed. The actual dose is equivalent to 15 months background radiation and represents an additional risk of lifetime cancer of 1 in 7400.
Where is the study run from?
Participants will be recruited from the following sites:
1. West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, UK
2. Wessex Cardiothoracic Centre, Southampton University Hospital, Southampton, UK
3. Hairmyres Hospital, East Kilbride, UK
4. Royal Blackburn Hospital, Blackburn, UK
5. Freeman Hospital, Newcastle, UK
6. City Hospitals Sunderland NHS Foundation, Sunderland, UK
When is study starting and how long is it expected to run for?
The study ran from October 2011 to December 2012.
Who is funding the study?
British Heart Foundation (BHF) (UK).
Who is the main contact?
Ms Joanne Kelly
Joanne.kelly@gjnh.scot.nhs.uk
Contact information
Scientific
Clinical Governance and Risk Management Development Unit (CGRMDU)
Beardmore Street
Clydebank
G81 4HX
United Kingdom
| Joanne.kelly@gjnh.scot.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | FAMOUS NSTEMI |
| Study objectives | Current hypothesis as of 06/05/2014: 1. Routine FFR measurement increases the proportion of NSTEMI patients that will be managed medically 2. Routine FFR measurement in NSTEMI patients is feasible and has additive diagnostic, clinical and health economic utility compared to standard care based on visual assessment of the angiogram Previous hypothesis: Do treatment decisions correspond to FFR values in individual coronary arteries in patients with recent non-ST elevation myocardial infarction (NSTEMI)? |
| Ethics approval(s) | The West Glasgow Hospital Ethics Committee First MREC approval date 01/03/2011, ref:11/S0703/6 |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Coronary Artery |
| Intervention | 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. Added 06/05/2014: Clinicians and patients will be blinded to the FFR results in the angiography-guided group (double blind). |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 06/05/2014: 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) Previous primary outcome measures: 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 measures | Current secondary outcome measures as of 06/05/2014: 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 EQ-5D QoL between each group at 12 months 5. Relationship between FFR results and health outcomes in the longer term 6. The composite of cardiovascular death/non-fatal myocardial infarction (MI)/unplanned hospitalisation for transient ischaemic attack or stroke 7. Cardiac death, or unplanned hospitalisation for myocardial infarction or heart failure 8. MI is defined according to the criteria specified in the Third Universal Definition of Myocardial Infarction (including Type 4 MI for PCI and Type 5 for CABG) Previous secondary outcome measures: 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 |
| Overall study start date | 21/10/2011 |
| Completion date | 01/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 350; UK Sample Size: 350 |
| Key inclusion criteria | Current inclusion criteria as of 06/05/2014: 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 3 days of admission or a history of recurrent ischaemic symptoms within 5 days (according to contemporary published guidelines) Previous 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) |
| Key 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 |
| Date of first enrolment | 21/10/2011 |
| Date of final enrolment | 01/05/2014 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
G81 4HX
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Governance and Risk Management Development Unit (CGRMDU)
Beardmore Street
Clydebank
G81 4HX
Scotland
United Kingdom
"ROR" |
https://ror.org/0103jbm17 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2013 | Yes | No | |
| Results article | results | 07/01/2015 | Yes | No | |
| Results article | cost-effectiveness results | 14/11/2015 | Yes | No |
Editorial Notes
04/10/2018: Publication references added.
06/05/2014: The overall trial end date was changed from 25/12/2012 to 01/05/2014.
