Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06070662
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-03-25
Brief Title:
Non-invasive Diagnosis of Coronary Microvascular Disease Pilot Study
Sponsor:
University of Leicester
Organization:
University of Leicester
Study Overview
Official Title:
Non-invasive Diagnosis of Coronary Microvascular Disease Using Novel CMR and CT Techniques a Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-09
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:
40 of patients presenting with stable chest pain angina have no significant blockage of the main heart arteries Identifying why these patients have symptoms will mean better treatment options can be developed
About 60 of these patients have evidence of coronary microvascular disease CMD In this condition there is a problem with the hearts microvessels very small blood vessels that branch from the main heart arteries Due to problems with these vessels there is a mismatch between the blood supply to the heart and its oxygen consumption causing chest pain and this can also lead to major heart events
At present to diagnose this condition specialised techniques during an invasive test called a coronary angiogram are required As this is an invasive test it can be lead to complications and cause discomfort
Non-invasive ways of diagnosing CMD are required to improve the diagnosis and management of this condition
This study aims to provide initial data on whether novel imaging techniques using CT and MRI scans which are much less invasive could identify CMD
To do this patients with suspected angina referred for angiography and who are already participants in the main research study CMR versus CT-FFR in CAD study will be recruited
These will be patients with suspected CMD and also those with blockage of the main heart arteries triple vessel disease to compare against
Participants in this pilot study will have additional tests used to diagnose CMD during their invasive angiography procedure Participants will then have an MRI scan involving novel techniques and exercise MRI where individuals exercise use a cycle or stepping machine during the MRI scan Further analysis will also be undertaken of CT images acquired as part of the main study
These tests will be compared against invasive test results to see which show potential in being able to diagnose CMD
About 60 of these patients have evidence of coronary microvascular disease CMD In this condition there is a problem with the hearts microvessels very small blood vessels that branch from the main heart arteries Due to problems with these vessels there is a mismatch between the blood supply to the heart and its oxygen consumption causing chest pain and this can also lead to major heart events
At present to diagnose this condition specialised techniques during an invasive test called a coronary angiogram are required As this is an invasive test it can be lead to complications and cause discomfort
Non-invasive ways of diagnosing CMD are required to improve the diagnosis and management of this condition
This study aims to provide initial data on whether novel imaging techniques using CT and MRI scans which are much less invasive could identify CMD
To do this patients with suspected angina referred for angiography and who are already participants in the main research study CMR versus CT-FFR in CAD study will be recruited
These will be patients with suspected CMD and also those with blockage of the main heart arteries triple vessel disease to compare against
Participants in this pilot study will have additional tests used to diagnose CMD during their invasive angiography procedure Participants will then have an MRI scan involving novel techniques and exercise MRI where individuals exercise use a cycle or stepping machine during the MRI scan Further analysis will also be undertaken of CT images acquired as part of the main study
These tests will be compared against invasive test results to see which show potential in being able to diagnose CMD
Detailed Description:
Coronary artery disease CAD is the leading cause of morbidity and mortality in the United Kingdom Approximately 40 of patients presenting with angina however have no evidence of significant obstructive CAD
About 60 of these patients have evidence of coronary microvascular disease CMD where there is dysfunction of the coronary microvessels leading to a mismatch between the blood supply to the myocardium and oxygen consumption This may be due to a number of structural and functional changes including vascular remodelling perivascular fibrosis endothelial dysfunction and vascular smooth muscle dysfunction Although previously thought of as a benign entity recent studies suggest that CMD is associated with major adverse events
Symptoms caused by CMD and obstructive CAD cannot be distinguished sufficiently to guide diagnosis and management plans and conventional cardiac risk factors are poor discriminators of the two conditions therefore clinicians are reliant on further investigations to diagnose CMD
Growing evidence supports invasive coronary physiological testing for this and methods to measure coronary vascular function during angiography have been developed Once significant epicardial CAD has been excluded CMD can be identified by impaired coronary flow reserve CFR and the index of microvascular resistance IMR
Despite the ability of invasive testing to detect CMD these methods come with attendant risks as well as cost implications Additionally there is limited expertise and uptake amongst interventional cardiologists in intracoronary physiological assessment limiting its widespread use Hence non-invasive surrogates are required to improve diagnosis and management of CMD However currently available non-invasive tests including exercise ECG stress echocardiography and nuclear imaging lack the sensitivity and specificity to diagnose CMD
Microvascular volume analysed using novel imaging methods may provide the diagnostic accuracy required for the non-invasive identification of CMD In CMD patients may exhibit reduced microvascular volume in contrast to epicardial disease where there is microvascular expansion and therefore these methods may be able to differentiate between the two disease processes A number of methods have been proposed for assessment of microvascular volume using computed tomography CT and CMR These methods include coronary luminal volume to myocardial mass VM ratio using computational CT analysis as well as CMR methods such as T1 mapping and Blood oxygen level-dependent CMR Furthermore compared to using pharmacological stress exercise CMR could provide superior diagnostic ability to identify CMD as it allows assessment during more physiological stress
This study aims to provide pilot data on whether these novel CT and MRI and the use of physiological stress exercise CMR could identify CMD in patients presenting with angina It aims to identify which of the proposed imaging methods could prove to be clinically useful for non-invasive identification of CMD providing justification for a larger-scale diagnostic accuracy study
This is a prospective single centre pilot study which will recruit individuals with angina referred for angiography who are participants in the research study CMR versus CT-FFR in CAD
This pilot study will recruit both patients with suspected CMD and controls with multi-vessel CAD to compare against
Participants will be consented to have additional invasive testing at angiography for CMD Those with confirmed CMD at angiography and all control participants will then have an MRI scan compromising of advanced MRI techniques for assessment of microvascular volume at rest and physiological stress exercise In addition previously acquired CT images from the main research study will be transferred to Heartflow for computation of coronary blood volume
This will allow assessment of whether the novel imaging modalities proposed could be clinically useful for non-invasive identification of CMD and distinction from epicardial disease to inform larger future studies of these techniques
About 60 of these patients have evidence of coronary microvascular disease CMD where there is dysfunction of the coronary microvessels leading to a mismatch between the blood supply to the myocardium and oxygen consumption This may be due to a number of structural and functional changes including vascular remodelling perivascular fibrosis endothelial dysfunction and vascular smooth muscle dysfunction Although previously thought of as a benign entity recent studies suggest that CMD is associated with major adverse events
Symptoms caused by CMD and obstructive CAD cannot be distinguished sufficiently to guide diagnosis and management plans and conventional cardiac risk factors are poor discriminators of the two conditions therefore clinicians are reliant on further investigations to diagnose CMD
Growing evidence supports invasive coronary physiological testing for this and methods to measure coronary vascular function during angiography have been developed Once significant epicardial CAD has been excluded CMD can be identified by impaired coronary flow reserve CFR and the index of microvascular resistance IMR
Despite the ability of invasive testing to detect CMD these methods come with attendant risks as well as cost implications Additionally there is limited expertise and uptake amongst interventional cardiologists in intracoronary physiological assessment limiting its widespread use Hence non-invasive surrogates are required to improve diagnosis and management of CMD However currently available non-invasive tests including exercise ECG stress echocardiography and nuclear imaging lack the sensitivity and specificity to diagnose CMD
Microvascular volume analysed using novel imaging methods may provide the diagnostic accuracy required for the non-invasive identification of CMD In CMD patients may exhibit reduced microvascular volume in contrast to epicardial disease where there is microvascular expansion and therefore these methods may be able to differentiate between the two disease processes A number of methods have been proposed for assessment of microvascular volume using computed tomography CT and CMR These methods include coronary luminal volume to myocardial mass VM ratio using computational CT analysis as well as CMR methods such as T1 mapping and Blood oxygen level-dependent CMR Furthermore compared to using pharmacological stress exercise CMR could provide superior diagnostic ability to identify CMD as it allows assessment during more physiological stress
This study aims to provide pilot data on whether these novel CT and MRI and the use of physiological stress exercise CMR could identify CMD in patients presenting with angina It aims to identify which of the proposed imaging methods could prove to be clinically useful for non-invasive identification of CMD providing justification for a larger-scale diagnostic accuracy study
This is a prospective single centre pilot study which will recruit individuals with angina referred for angiography who are participants in the research study CMR versus CT-FFR in CAD
This pilot study will recruit both patients with suspected CMD and controls with multi-vessel CAD to compare against
Participants will be consented to have additional invasive testing at angiography for CMD Those with confirmed CMD at angiography and all control participants will then have an MRI scan compromising of advanced MRI techniques for assessment of microvascular volume at rest and physiological stress exercise In addition previously acquired CT images from the main research study will be transferred to Heartflow for computation of coronary blood volume
This will allow assessment of whether the novel imaging modalities proposed could be clinically useful for non-invasive identification of CMD and distinction from epicardial disease to inform larger future studies of these techniques
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None