NonST Elevation Myocardial Infarction Clinical Trial
Official title:
Fractional Flow Reserve Versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary Syndromes - A 3.0 Tesla Stress Perfusion MRI Sub-Study (FAMOUS-NSTEMI MRI)
| Verified date | June 2017 |
| Source | NHS National Waiting Times Centre Board |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
BACKGROUND: Non-ST-segment elevation myocardial infarction (NSTEMI) is the commonest type of
acute coronary syndrome (ACS) and has a poor long-term prognosis. Guidewire-based coronary
pressure measurement of the myocardial fractional flow reserve (FFR) is validated for
measuring the severity of a coronary lesion narrowing in patients with stable angina. FFR
measurement in patients with a recent ACS has theoretical limitations and is not fully
validated.
AIM: To prospectively assess heart muscle blood flow and injury with guide-wire based
methods at the time of the clinically-indicated angiogram and compare these results with
those from a stress perfusion MRI scan in medically-stabilised NSTEMI..
HYPOTHESIS: 1) FFR measured invasively will correspond closely with findings from stress
perfusion MRI, 2) MRI will provide clinically-relevant information on heart muscle injury,
function and salvage, 3) Guidewire-derived measurements of coronary microvascular function
will be associated with the MRI findings.
DESIGN: The MRI study will be performed in patients who give informed consent in the
FAMOUS-NSTEMI clinical trial (NCT registration 01764334). All of the clinical data for these
participants will be available to link with the MRI results.
| Status | Completed |
| Enrollment | 106 |
| Est. completion date | December 10, 2016 |
| Est. primary completion date | June 10, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - (1) Participation in the FAMOUS NSTEMI clinical trial (NCT registration 01764334); (2) age >18 years; (3) written informed consent. Exclusion Criteria: - 1) Contra-indications to MRI including metallic devices and severe kidney disease (i.e. an estimated glomerular filtration rate <30 ml/min/1.73 m2). |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | BHF Glasgow Cardiovascular Research Centre | Glasgow | Strathclyde |
| Lead Sponsor | Collaborator |
|---|---|
| NHS National Waiting Times Centre Board | British Heart Foundation, NHS Greater Glasgow and Clyde, NHS Lanarkshire, University of Glasgow |
United Kingdom,
Berry C, Layland J, Sood A, Curzen NP, Balachandran KP, Das R, Junejo S, Henderson RA, Briggs AH, Ford I, Oldroyd KG. Fractional flow reserve versus angiography in guiding management to optimize outcomes in non-ST-elevation myocardial infarction (FAMOUS-NSTEMI): rationale and design of a randomized controlled clinical trial. Am Heart J. 2013 Oct;166(4):662-668.e3. doi: 10.1016/j.ahj.2013.07.011. Epub 2013 Aug 27. — View Citation
Layland J, Rauhalammi S, Lee MM, Ahmed N, Carberry J, Teng Yue May V, Watkins S, McComb C, Mangion K, McClure JD, Carrick D, O'Donnell A, Sood A, McEntegart M, Oldroyd KG, Radjenovic A, Berry C. Diagnostic Accuracy of 3.0-T Magnetic Resonance T1 and T2 Ma — View Citation
Layland J, Rauhalammi S, Watkins S, Ahmed N, McClure J, Lee MM, Carrick D, O'Donnell A, Sood A, Petrie MC, May VT, Eteiba H, Lindsay M, McEntegart M, Oldroyd KG, Radjenovic A, Berry C. Assessment of Fractional Flow Reserve in Patients With Recent Non-ST-S — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correspondence between FFR and myocardial perfusion revealed by adenosine stress perfusion MRI. | FFR is a guidewire based measurement of lesion-level flow limitation during hyperaemia. An MRI perfusion defect is classified as significant according to the presence of ischaemia in 2 segments of a 32 segment model i.e: > 60 degrees in either the basal or the mid-ventricular slices or > 90 degrees in the apical slice or any transmural defect or two adjacent slices. FFR and MRI will be correlated in corresponding coronary artery territories based on coronary anatomy. The analysis is for diagnostic accuracy of FFR vs. myocardial perfusion as assessed by MRI in temporally associated assessments at baseline. | MRI at baseline | |
| Secondary | Myocardial Infarction | Presence and extent (% left ventricular volume) of infarction, as revealed by late gadolinium contrast enhancement. | Baseline MRI scan | |
| Secondary | Myocardial area-at-risk | The myocardial ischaemic area-at-risk revealed by non-contrast MRI methods (T1 mapping, T2 mapping, T2-weighted MRI). | Baseline MRI scan | |
| Secondary | Myocardial salvage | Myocardial salvage is estimated by subtraction of infarct size from the initial area-at-risk. Salvage may be estimated at baseline with initial infarct size or at follow-up (final infarct size). | Baseline and follow-up MRI (average 12 months) | |
| Secondary | Myocardial salvage index | Myocardial salvage index is estimated by indexing infarct size to the initial area-at-risk. Salvage may be estimated at baseline with initial infarct size or at follow-up with final infarct size. | Baseline and follow-up MRI (average 12 months) | |
| Secondary | Left ventricular ejection fraction | Left ventricular ejection fraction (LVEF) is an index of left ventricular systolic function, and a surrogate outcome measure of treatment efficacy and patient outcome. | Baseline and follow-up MRI (average 12 months) | |
| Secondary | Culprit artery assignment | Magnetic resonance imaging of myocardial ischaemic injury with non-contrast MRI methods should theoretically identify the culprit artery in patients with a recent non-ST elevation myocardial infarction. The MRI methods to be used in this study include T1 mapping (MOLLI, Siemens Healthcare), T2 mapping (bSSFP, Siemens Healthcare) and T2-STIR (dark blood oedema MRI). The diagnostic accuracy of these three methods will be compared using a combination of clinical parameters (ECG, coronary angiogram, invasive adjunctive diagnostic methods, contrast enhanced MRI) which together represent the reference dataset for culprit artery assignment in individual patients. | Baseline MRI scan | |
| Secondary | Microvascular obstruction | Microvascular obstruction revealed by MRI is due to a failure of gadolinium contrast to diffuse into the infarct zone because of extrinsic compression (e.g. oedema) and intrinsic obstruction (e.g. microvascular thrombosis). | Baseline MRI scan | |
| Secondary | Myocardial haemorrhage | Myocardial haemorrhage is a consequence of vascular damage and is related to the duration of ischaemia, infarct severity and coronary reperfusion. Transverse (T2) and T2* magnetisation are destroyed by the paramagnetic effects of deoxyhaemoglobin. Signal loss in T2*-weighted images have high positive predictive accuracy for myocardial haemorrhage. T2 and T2* mapping methods, and STIR (dark blood MRI) will be used to assess the incidence of haemorrhage. | Baseline MRI | |
| Secondary | Regional myocardial strain | Myocardial strain is an intrinsic property of myocardial contractility. Left ventricular (LV) thickening and inward LV motion (which is how LVEF is calculated) are passive phenomena secondary to active circumferential shortening and sources of artefact (such as through plane motion) can misrepresent actual LV contractility. Strain-encoded cardiac MRI with DENSE will be used to assess regional strain in the left ventricle, segmented according to the American Heart Association model. The mid-ventricular level will be a particular region of interest. | Baseline and follow-up MRI (average 12 months) | |
| Secondary | Adenosine response | FFR and perfusion MRI require systemic vasodilatation. In this study, systemic hyperaemia is induced by administration of intravenous adenosine (140 ug/kg/min - 210 ug/kg/min). The patient response (symptoms, haemodynamics, MRI) will be assessed prospectively. | Baseline |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01764334 -
Fractional Flow Reserve Versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary Syndromes
|
Phase 4 |