FAMOUS-NSTEMI MRI Sub-Study
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)
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.
연구 개요
상세 설명
BACKGROUND: Non-ST 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 a prognostically-validated invasive method for measuring coronary lesion severity in patients with stable coronary artery disease. FFR measurement in patients with unstable coronary disease has theoretical limitations and is not fully validated in NSTEMI.
AIM: To prospectively evaluate ischaemia and infarction with adenosine stress perfusion cardiac MRI in medically-stabilised NSTEMI patients in whom FFR has been measured.
METHODS: In the FAMOUS-NSTEMI clinical trial (NCT registration 01764334), medically-stabilised patients with recent NSTEMI will have lesion-level ischaemia measured with FFR in all coronary artery stenoses amenable to revascularisation, as clinically appropriate.
Consecutive study participants will be invited to have an adenosine (140 µg/kg/min) stress 3.0 Tesla cardiac MRI scan to assess myocardial perfusion on up to three occasions: 1) before coronary angiography, 2) within 10 days post coronary angiography and finally, 3) 6 months after hospital admission. MRI will also assess myocardial pathophysiology including ischaemia, oedema, haemorrhage and infarct scar. MRI will provide the reference dataset. Guidewire-derived parameters were obtained and assessed blind to the MRI results.
The primary outcome is the correspondence between the presence or absence of an inducible-myocardial perfusion defect and FFR ≤ or > 0.80 in the MRI scans at baseline or post-angiography. Secondary outcomes include the correlation between measures of infarct severity as revealed by MRI (infarct size, myocardial salvage, microvascular obstruction, myocardial haemorrhage, myocardial strain) and invasive measures of coronary function (1) coronary collateral supply (fractional coronary collateral supply), (2) microcirculatory resistance (index of microvascular resistance), and (3) vasodilator capacity (resistive reserve ratio).
The project was funded by the British Heart Foundation and Chief Scientist Office. The pressure wires were provided through a restricted grant from St Jude Medical. The funders of the study have no involvement in the study design, analysis, interpretation, or presentation of the results.
VALUE: This study will provide clinically important information on the relationships between coronary artery and microcirculatory function measured invasively and ischaemia and MI pathologies, as revealed by non-invasively by MRI.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Strathclyde
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Glasgow, Strathclyde, 영국, G12 8TA
- BHF Glasgow Cardiovascular Research Centre
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Non-ST elevation myocardial infarction
Natural history study of non-ST elevation myocardial infarction and coronary physiology
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Guidewire-based index of coronary artery stenosis severity measured when coronary microvascular resistance is minimised by administration of a vasodilator drug.
다른 이름들:
Cardiac magnetic resonance imaging at 3.0 Tesla, including perfusion MRI at rest and during pharmacological stress with intravenous adenosine (140-210 ug/kg/min).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correspondence between FFR and myocardial perfusion revealed by adenosine stress perfusion MRI.
기간: MRI at baseline
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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.
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MRI at baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Myocardial Infarction
기간: Baseline MRI scan
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Presence and extent (% left ventricular volume) of infarction, as revealed by late gadolinium contrast enhancement.
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Baseline MRI scan
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Myocardial area-at-risk
기간: Baseline MRI scan
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The myocardial ischaemic area-at-risk revealed by non-contrast MRI methods (T1 mapping, T2 mapping, T2-weighted MRI).
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Baseline MRI scan
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Myocardial salvage
기간: Baseline and follow-up MRI (average 12 months)
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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).
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Baseline and follow-up MRI (average 12 months)
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Myocardial salvage index
기간: Baseline and follow-up MRI (average 12 months)
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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.
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Baseline and follow-up MRI (average 12 months)
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Left ventricular ejection fraction
기간: Baseline and follow-up MRI (average 12 months)
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Left ventricular ejection fraction (LVEF) is an index of left ventricular systolic function, and a surrogate outcome measure of treatment efficacy and patient outcome.
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Baseline and follow-up MRI (average 12 months)
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Culprit artery assignment
기간: Baseline MRI scan
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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.
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Baseline MRI scan
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Microvascular obstruction
기간: Baseline MRI scan
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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).
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Baseline MRI scan
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Myocardial haemorrhage
기간: Baseline MRI
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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.
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Baseline MRI
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Regional myocardial strain
기간: Baseline and follow-up MRI (average 12 months)
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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.
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Baseline and follow-up MRI (average 12 months)
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Adenosine response
기간: Baseline
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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.
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Baseline
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공동 작업자 및 조사자
수사관
- 수석 연구원: Colin Berry, MB ChB BSc FRCP FACC, University of Glasgow
간행물 및 유용한 링크
일반 간행물
- 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.
- 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-Segment-Elevation Myocardial Infarction: Comparative Study With 3-T Stress Perfusion Cardiac Magnetic Resonance Imaging. Circ Cardiovasc Interv. 2015 Aug;8(8):e002207. doi: 10.1161/CIRCINTERVENTIONS.114.002207.
- 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 Mapping and T2-Weighted Dark-Blood Imaging for the Infarct-Related Coronary Artery in Non-ST-Segment Elevation Myocardial Infarction. J Am Heart Assoc. 2017 Mar 31;6(4):e004759. doi: 10.1161/JAHA.116.004759.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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Fractional flow reserve에 대한 임상 시험
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National Heart Centre Singapore알려지지 않은
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HeartFlow, Inc.Case Western Reserve University완전한
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Assistance Publique - Hôpitaux de Paris모병