Ignite Creation Date:
2024-05-06 @ 2:35 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02073422
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2014-02-19
Brief Title:
FAMOUS-NSTEMI MRI Sub-Study
Sponsor:
NHS National Waiting Times Centre Board
Organization:
NHS National Waiting Times Centre Board
Study Overview
Official Title:
Fractional Flow Reserve Versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary Syndromes - A 30 Tesla Stress Perfusion MRI Sub-Study FAMOUS-NSTEMI MRI
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 µgkgmin stress 30 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 080 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
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 µgkgmin stress 30 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 080 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PG115528999 | OTHER_GRANT | British Heart Foundation PG115528999 | None |