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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Strathclyde
-
Glasgow、Strathclyde、イギリス、G12 8TA
- BHF Glasgow Cardiovascular Research Centre
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Non-ST elevation myocardial infarction
Natural history study of non-ST elevation myocardial infarction and coronary physiology
|
Guidewire-based index of coronary artery stenosis severity measured when coronary microvascular resistance is minimised by administration of a vasodilator drug.
他の名前：
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).
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Correspondence between FFR and myocardial perfusion revealed by adenosine stress perfusion MRI.
時間枠：MRI at baseline
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Myocardial Infarction
時間枠：Baseline MRI scan
|
Presence and extent (% left ventricular volume) of infarction, as revealed by late gadolinium contrast enhancement.
|
Baseline MRI scan
|
|
Myocardial area-at-risk
時間枠：Baseline MRI scan
|
The myocardial ischaemic area-at-risk revealed by non-contrast MRI methods (T1 mapping, T2 mapping, T2-weighted MRI).
|
Baseline MRI scan
|
|
Myocardial salvage
時間枠：Baseline and follow-up MRI (average 12 months)
|
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)
|
|
Myocardial salvage index
時間枠：Baseline and follow-up MRI (average 12 months)
|
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)
|
|
Left ventricular ejection fraction
時間枠：Baseline and follow-up MRI (average 12 months)
|
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)
|
|
Culprit artery assignment
時間枠：Baseline MRI scan
|
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
|
|
Microvascular obstruction
時間枠：Baseline MRI scan
|
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
|
|
Myocardial haemorrhage
時間枠：Baseline MRI
|
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
|
|
Regional myocardial strain
時間枠：Baseline and follow-up MRI (average 12 months)
|
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)
|
|
Adenosine response
時間枠：Baseline
|
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
|
協力者と研究者
捜査官
- 主任研究者：Colin Berry, MB ChB BSc FRCP FACC、University of Glasgow
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Fractional flow reserveの臨床試験
-
Assistance Publique - Hôpitaux de Paris募集
-
Zekai Tahir Burak Women's Health Research and Education...完了死 | 気管支肺異形成