Coronary Artery DiseaseOE-MRINCT05163327
Oxygen-enhanced Magnetic Resonance Imaging (OE-MRI) of the Heart: A Feasibility Study
An observational study of Coronary Artery Disease, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This exploratory pilot study aims to set up cardiac oxygen enhanced magnetic resonance imaging (OE-MRI). It will involve 10 healthy volunteers and 10 patients with known coronary artery disease (CAD) having a MRI scan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Oxygen-enhanced Cardiac MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Ten healthy volunteers and 10 patients with CAD
Who may be able to join
- 10 healthy volunteers and 10 patients with known significant (defined as > 70% stenosis) single or 2 vessel CAD
- Male or female > 18 years of age
- Females will be non-pregnant and non-lactating
Who cannot join
- Contraindication to MRI (including claustrophobia)
- History of any significant lung disease including asthma and COPD
- History of type II respiratory failure
- Second degree and higher atrio-ventricular conduction delay
- Patients taking Dipyridamole, or theophylline-based medication
- Significant left main stem coronary artery disease
Show all 10Show fewer
- Recent myocardial infarction (within 2 months)
- Unstable angina
- Abnormal heart rhythm e.g. atrial fibrillation, atrial flutter, atrial or ventricular bigeminy
- Pregnancy/breast-feeding. Women of childbearing potential (not >2 years post- menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M23 9LT
About this study
This exploratory pilot study aims to set up cardiac oxygen enhanced magnetic resonance imaging (OE-MRI). It will involve 10 healthy volunteers and 10 patients with known coronary artery disease (CAD) having a MRI scan.
If positive, this data would be used to power an appropriately sized study assessing the utility of cardiac OE-MRI in CAD and other cardiac pathologies.
Read the detailed description
Determining the presence and severity of myocardial ischaemia is a key goal in the effective management of coronary artery disease (CAD). Untreated ischaemia is an important determinant of adverse outcome, and the benefits of ischemia-driven revascularization are well recognized.1
Anatomic appearances of coronary artery disease are poorly predictive of myocardial ischemia.1 2 Therefore, concurrent assessment of the functional severity of coronary stenosis is used to guide revascularization.3 In the clinical setting, a number of imaging methods are available, including nuclear techniques, echocardiography, and cardiovascular magnetic resonance (CMR). Such modalities assess flow heterogeneity and contractile abnormalities, but these serve as surrogates of myocardial ischemia: ischemia per se is not measured. Furthermore, these functional imaging modalities rely on the use of exogenous contrast agents, which, albeit small, carry additional risks and can be contraindicated in certain populations.
Blood oxygen level dependent (BOLD) imaging exploits the inherent paramagnetic properties of haemoglobin.4 The transition from diamagnetic oxyhaemoglobin to paramagnetic deoxyhaemoglobin induces magnetic susceptibility differences, resulting in a change in magnetic resonance signal intensity and thereby generating oxygen dependent contrast. Thus BOLD imaging provides insight into myocardial tissue oxygenation. Since hypoxia is the initiator of the ischaemic cascade, assessment of regional myocardial oxygenation with BOLD imaging has been hypothesised to reflect more directly the imbalance between oxygen supply and demand and be sensitive for detecting CAD. Indeed initial evaluation of BOLD imaging for detecting CAD has produced promising results.5-7 Furthermore, BOLD has provided pathological insight into other myocardial pathologies. Myocardial perfusion (blood flow) can be dissociated from oxygenation i.e. hypoperfusion is not necessarily commensurate with tissue hypoxia. For example, myocardial oxygen demand may be down-regulated in hibernating myocardium, and may be upregulated in hypertrophic cardiomyopathy (HCM) due to the increased cost of energy metabolism. In HCM mutation carriers without left ventricular hypertrophy, Karamitsos et al demonstrated normal myocardial perfusion reserve, but abnormal myocardial oxygenation during stress, possibly explained by the fact that sarcomere gene mutations increase the energy cost of contraction before the onset of hypertrophy.8
However, BOLD imaging is associated with a number of disadvantages. First, since the BOLD signal reflects deoxyhaemoglobin which is confined to blood vessels, it doesn't truly reflect tissue oxygen status.9 Second, the BOLD signal is also dependent on vessel geometry, changes in blood flow and blood volume, which thus can confound the signal.9 Finally, the CMR techniques used to measure the BOLD signal (T2* of T2) are not quantitative since a change in T2* or T2 cannot be related to a change in the partial pressure of oxygen (PO2). Instead, semi-quantitative measurements are made using signal intensity and are assumed to reflect oxygenation.
Oxygen enhanced magnetic resonance imaging (OE-MRI) potentially overcomes these limitations. Oxygen itself has paramagnetic properties; it increases the proton longitudinal relaxation rate (R1) of water containing dissolved oxygen.10 The measured change in R1 (= 1/T1, where T1 relaxation time is an inherent magnetic property of all tissues) induced by breathing oxygen is directly proportional to the change in PO2. In OE-MRI the change in R1 on breathing elevated concentrations of oxygen is measured. The benefits of OE-MRI over BOLD are therefore that it is sensitive to tissue oxygenation, it is not dependent on changes in blood flow and volume, and it is truly quantitative, since the change in R1 is directly proportional to the change in PO2. Thus it potentially offers a quantitative measure of myocardial oxygenation. OE-MRI has been used to assess lung tissue oxygenation,11 solid tumour oxygenation12 and to assess placental oxygenation in pregnant women13 on conventional clinical MRI scanners with very encouraging results.
OE-MRI has not been applied in the heart. We hypothesise that OE-MRI will allow non-invasive, non-ionising, and quantitative assessment of myocardial tissue oxygenation, that is free from exogenous contrast agent. If this is the case, OE-MRI will offer enormous potential in terms of the diagnosis and management of CAD, and in terms of providing pathophysiological insight into cardiac disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Oxygen-enhanced Cardiac MRI
- Keywords
- MRI, Imaging
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen-enhanced Cardiac MRIProcedure or surgery
The MRI scan will include assessment of cardiac function. Myocardial magnetic properties (T1, T2, T2*) will be measured while patients are breathing room air, oxygen and during an infusion of adenosine. The scan will last for approximately 60 minutes. Prior to the scan patients will have an intravenous cannula (venflon) placed in an arm vein.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | 10 Volunteers (Male or Female), aged18 or over, with no known history of Coronary Artery Disease Receives: Procedure: Oxygen-enhanced Cardiac MRI | |
| Known Coronary Artery Disease | 10 Volunteers (Male orFemale), aged 18 or over,with a known significant (defined as => 70% stenosis) single or 2 vessel Coronary Artery Disease Receives: Procedure: Oxygen-enhanced Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To apply OE-MRI in the heart and compare it to BOLD imaging
To apply OE-MRI in the heart and compare it to BOLD imaging
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study startJan 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Accumulated evidence (including data acquired in parallel studies, in other centres and in published literature) suggest that the technique was unlikely to produce a signal in the heart.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chris Miller, MBChB, MRCP, Principal investigator, Manchester University NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163327
- Sponsor's protocol ID
- Cardiac-OE-MRI-01
- Acronym
- OE-MRI
- Status last verified
- Jan 2023
- First submitted
- 6 Dec 2021
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
PubMed 19144937Uren NG, Melin JA, De Bruyne B, Wijns W, Baudhuin T, Camici PG. Relation between myocardial blood flow and the severity of coronary-artery stenosis. N Engl J Med. 1994 Jun 23;330(25):1782-8. doi: 10.1056/NEJM199406233302503.
PubMed 8190154Kern MJ, Lerman A, Bech JW, De Bruyne B, Eeckhout E, Fearon WF, Higano ST, Lim MJ, Meuwissen M, Piek JJ, Pijls NH, Siebes M, Spaan JA; American Heart Association Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology. Physiological assessment of coronary artery disease in the cardiac catheterization laboratory: a scientific statement from the American Heart Association Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology. Circulation. 2006 Sep 19;114(12):1321-41. doi: 10.1161/CIRCULATIONAHA.106.177276. Epub 2006 Aug 28.
PubMed 16940193Pauling L, Coryell CD. The Magnetic Properties and Structure of Hemoglobin, Oxyhemoglobin and Carbonmonoxyhemoglobin. Proc Natl Acad Sci U S A. 1936 Apr;22(4):210-6. doi: 10.1073/pnas.22.4.210. No abstract available.
PubMed 16577697Arnold JR, Karamitsos TD, Bhamra-Ariza P, Francis JM, Searle N, Robson MD, Howells RK, Choudhury RP, Rimoldi OE, Camici PG, Banning AP, Neubauer S, Jerosch-Herold M, Selvanayagam JB. Myocardial oxygenation in coronary artery disease: insights from blood oxygen level-dependent magnetic resonance imaging at 3 tesla. J Am Coll Cardiol. 2012 May 29;59(22):1954-64. doi: 10.1016/j.jacc.2012.01.055.
PubMed 22624835Karamitsos TD, Leccisotti L, Arnold JR, Recio-Mayoral A, Bhamra-Ariza P, Howells RK, Searle N, Robson MD, Rimoldi OE, Camici PG, Neubauer S, Selvanayagam JB. Relationship between regional myocardial oxygenation and perfusion in patients with coronary artery disease: insights from cardiovascular magnetic resonance and positron emission tomography. Circ Cardiovasc Imaging. 2010 Jan;3(1):32-40. doi: 10.1161/CIRCIMAGING.109.860148. Epub 2009 Nov 17.
PubMed 19920032Friedrich MG, Niendorf T, Schulz-Menger J, Gross CM, Dietz R. Blood oxygen level-dependent magnetic resonance imaging in patients with stress-induced angina. Circulation. 2003 Nov 4;108(18):2219-23. doi: 10.1161/01.CIR.0000095271.08248.EA. Epub 2003 Oct 13.
PubMed 14557359Karamitsos TD, Dass S, Suttie J, Sever E, Birks J, Holloway CJ, Robson MD, Jerosch-Herold M, Watkins H, Neubauer S. Blunted myocardial oxygenation response during vasodilator stress in patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 2013 Mar 19;61(11):1169-76. doi: 10.1016/j.jacc.2012.12.024.
PubMed 23498131Padhani AR, Krohn KA, Lewis JS, Alber M. Imaging oxygenation of human tumours. Eur Radiol. 2007 Apr;17(4):861-72. doi: 10.1007/s00330-006-0431-y. Epub 2006 Oct 17.
PubMed 17043737Young IR, Clarke GJ, Bailes DR, Pennock JM, Doyle FH, Bydder GM. Enhancement of relaxation rate with paramagnetic contrast agents in NMR imaging. J Comput Tomogr. 1981 Dec;5(6):543-7. doi: 10.1016/0149-936x(81)90089-8.
PubMed 7053127Kershaw LE, Naish JH, McGrath DM, Waterton JC, Parker GJ. Measurement of arterial plasma oxygenation in dynamic oxygen-enhanced MRI. Magn Reson Med. 2010 Dec;64(6):1838-42. doi: 10.1002/mrm.22571.
PubMed 20677232O'Connor JP, Naish JH, Parker GJ, Waterton JC, Watson Y, Jayson GC, Buonaccorsi GA, Cheung S, Buckley DL, McGrath DM, West CM, Davidson SE, Roberts C, Mills SJ, Mitchell CL, Hope L, Ton NC, Jackson A. Preliminary study of oxygen-enhanced longitudinal relaxation in MRI: a potential novel biomarker of oxygenation changes in solid tumors. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1209-15. doi: 10.1016/j.ijrobp.2008.12.040. Epub 2009 Mar 26.
PubMed 19327904Huen I, Morris DM, Wright C, Parker GJ, Sibley CP, Johnstone ED, Naish JH. R1 and R2 * changes in the human placenta in response to maternal oxygen challenge. Magn Reson Med. 2013 Nov;70(5):1427-33. doi: 10.1002/mrm.24581. Epub 2012 Dec 27.
PubMed 23280967
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen-enhanced Magnetic Resonance Imaging (OE-MRI) of the Heart: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05163327
- Acronym / sponsor ID
- OE-MRI / Cardiac-OE-MRI-01
- Conditions
- Coronary Artery Disease
- Keywords
- MRI, Imaging
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Accumulated evidence (including data acquired in parallel studies, in other centres and in published literature) suggest that the technique was unlikely to produce a signal in the heart.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- Jan 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory pilot study aims to set up cardiac oxygen enhanced magnetic resonance imaging (OE-MRI). It will involve 10 healthy volunteers and 10 patients with known coronary artery disease (CAD) having a MRI scan.
If positive, this data would be used to power an appropriately sized study assessing the utility of cardiac OE-MRI in CAD and other cardiac pathologies.
Detailed description
Determining the presence and severity of myocardial ischaemia is a key goal in the effective management of coronary artery disease (CAD). Untreated ischaemia is an important determinant of adverse outcome, and the benefits of ischemia-driven revascularization are well recognized.1
Anatomic appearances of coronary artery disease are poorly predictive of myocardial ischemia.1 2 Therefore, concurrent assessment of the functional severity of coronary stenosis is used to guide revascularization.3 In the clinical setting, a number of imaging methods are available, including nuclear techniques, echocardiography, and cardiovascular magnetic resonance (CMR). Such modalities assess flow heterogeneity and contractile abnormalities, but these serve as surrogates of myocardial ischemia: ischemia per se is not measured. Furthermore, these functional imaging modalities rely on the use of exogenous contrast agents, which, albeit small, carry additional risks and can be contraindicated in certain populations.
Blood oxygen level dependent (BOLD) imaging exploits the inherent paramagnetic properties of haemoglobin.4 The transition from diamagnetic oxyhaemoglobin to paramagnetic deoxyhaemoglobin induces magnetic susceptibility differences, resulting in a change in magnetic resonance signal intensity and thereby generating oxygen dependent contrast. Thus BOLD imaging provides insight into myocardial tissue oxygenation. Since hypoxia is the initiator of the ischaemic cascade, assessment of regional myocardial oxygenation with BOLD imaging has been hypothesised to reflect more directly the imbalance between oxygen supply and demand and be sensitive for detecting CAD. Indeed initial evaluation of BOLD imaging for detecting CAD has produced promising results.5-7 Furthermore, BOLD has provided pathological insight into other myocardial pathologies. Myocardial perfusion (blood flow) can be dissociated from oxygenation i.e. hypoperfusion is not necessarily commensurate with tissue hypoxia. For example, myocardial oxygen demand may be down-regulated in hibernating myocardium, and may be upregulated in hypertrophic cardiomyopathy (HCM) due to the increased cost of energy metabolism. In HCM mutation carriers without left ventricular hypertrophy, Karamitsos et al demonstrated normal myocardial perfusion reserve, but abnormal myocardial oxygenation during stress, possibly explained by the fact that sarcomere gene mutations increase the energy cost of contraction before the onset of hypertrophy.8
However, BOLD imaging is associated with a number of disadvantages. First, since the BOLD signal reflects deoxyhaemoglobin which is confined to blood vessels, it doesn't truly reflect tissue oxygen status.9 Second, the BOLD signal is also dependent on vessel geometry, changes in blood flow and blood volume, which thus can confound the signal.9 Finally, the CMR techniques used to measure the BOLD signal (T2* of T2) are not quantitative since a change in T2* or T2 cannot be related to a change in the partial pressure of oxygen (PO2). Instead, semi-quantitative measurements are made using signal intensity and are assumed to reflect oxygenation.
Oxygen enhanced magnetic resonance imaging (OE-MRI) potentially overcomes these limitations. Oxygen itself has paramagnetic properties; it increases the proton longitudinal relaxation rate (R1) of water containing dissolved oxygen.10 The measured change in R1 (= 1/T1, where T1 relaxation time is an inherent magnetic property of all tissues) induced by breathing oxygen is directly proportional to the change in PO2. In OE-MRI the change in R1 on breathing elevated concentrations of oxygen is measured. The benefits of OE-MRI over BOLD are therefore that it is sensitive to tissue oxygenation, it is not dependent on changes in blood flow and volume, and it is truly quantitative, since the change in R1 is directly proportional to the change in PO2. Thus it potentially offers a quantitative measure of myocardial oxygenation. OE-MRI has been used to assess lung tissue oxygenation,11 solid tumour oxygenation12 and to assess placental oxygenation in pregnant women13 on conventional clinical MRI scanners with very encouraging results.
OE-MRI has not been applied in the heart. We hypothesise that OE-MRI will allow non-invasive, non-ionising, and quantitative assessment of myocardial tissue oxygenation, that is free from exogenous contrast agent. If this is the case, OE-MRI will offer enormous potential in terms of the diagnosis and management of CAD, and in terms of providing pathophysiological insight into cardiac disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Procedure: Oxygen-enhanced Cardiac MRI10 Volunteers (Male or Female), aged18 or over, with no known history of Coronary Artery Disease |
| Known Coronary Artery Disease | – | Procedure: Oxygen-enhanced Cardiac MRI10 Volunteers (Male orFemale), aged 18 or over,with a known significant (defined as => 70% stenosis) single or 2 vessel Coronary Artery Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Ten healthy volunteers and 10 patients with CAD
Key inclusion criteria (3 listed)
- 10 healthy volunteers and 10 patients with known significant (defined as > 70% stenosis) single or 2 vessel CAD
- Male or female > 18 years of age
- Females will be non-pregnant and non-lactating
Key exclusion criteria (10 listed)
- Contraindication to MRI (including claustrophobia)
- History of any significant lung disease including asthma and COPD
- History of type II respiratory failure
- Second degree and higher atrio-ventricular conduction delay
- Patients taking Dipyridamole, or theophylline-based medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen-enhanced Cardiac MRIThe MRI scan will include assessment of cardiac function. Myocardial magnetic properties (T1, T2, T2*) will be measured while patients are breathing room air, oxygen and during an infusion of adenosine. The scan will last for approximately 60 minutes. Prior to the scan patients will have an intravenous cannula (venflon) placed in an arm vein. | Procedure or surgery | Healthy Volunteer, Known Coronary Artery Disease |
Primary outcome
To apply OE-MRI in the heart and compare it to BOLD imaging
Time frame: 24 Months
To apply OE-MRI in the heart and compare it to BOLD imaging
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 19144937Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
- Background: PubMed 8190154Uren NG, Melin JA, De Bruyne B, Wijns W, Baudhuin T, Camici PG. Relation between myocardial blood flow and the severity of coronary-artery stenosis. N Engl J Med. 1994 Jun 23;330(25):1782-8. doi: 10.1056/NEJM199406233302503.
- Background: PubMed 16940193Kern MJ, Lerman A, Bech JW, De Bruyne B, Eeckhout E, Fearon WF, Higano ST, Lim MJ, Meuwissen M, Piek JJ, Pijls NH, Siebes M, Spaan JA; American Heart Association Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology. Physiological assessment of coronary artery disease in the cardiac catheterization laboratory: a scientific statement from the American Heart Association Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology. Circulation. 2006 Sep 19;114(12):1321-41. doi: 10.1161/CIRCULATIONAHA.106.177276. Epub 2006 Aug 28.
- Background: PubMed 16577697Pauling L, Coryell CD. The Magnetic Properties and Structure of Hemoglobin, Oxyhemoglobin and Carbonmonoxyhemoglobin. Proc Natl Acad Sci U S A. 1936 Apr;22(4):210-6. doi: 10.1073/pnas.22.4.210. No abstract available.
- Background: PubMed 22624835Arnold JR, Karamitsos TD, Bhamra-Ariza P, Francis JM, Searle N, Robson MD, Howells RK, Choudhury RP, Rimoldi OE, Camici PG, Banning AP, Neubauer S, Jerosch-Herold M, Selvanayagam JB. Myocardial oxygenation in coronary artery disease: insights from blood oxygen level-dependent magnetic resonance imaging at 3 tesla. J Am Coll Cardiol. 2012 May 29;59(22):1954-64. doi: 10.1016/j.jacc.2012.01.055.
- Background: PubMed 19920032Karamitsos TD, Leccisotti L, Arnold JR, Recio-Mayoral A, Bhamra-Ariza P, Howells RK, Searle N, Robson MD, Rimoldi OE, Camici PG, Neubauer S, Selvanayagam JB. Relationship between regional myocardial oxygenation and perfusion in patients with coronary artery disease: insights from cardiovascular magnetic resonance and positron emission tomography. Circ Cardiovasc Imaging. 2010 Jan;3(1):32-40. doi: 10.1161/CIRCIMAGING.109.860148. Epub 2009 Nov 17.
- Background: PubMed 14557359Friedrich MG, Niendorf T, Schulz-Menger J, Gross CM, Dietz R. Blood oxygen level-dependent magnetic resonance imaging in patients with stress-induced angina. Circulation. 2003 Nov 4;108(18):2219-23. doi: 10.1161/01.CIR.0000095271.08248.EA. Epub 2003 Oct 13.
- Background: PubMed 23498131Karamitsos TD, Dass S, Suttie J, Sever E, Birks J, Holloway CJ, Robson MD, Jerosch-Herold M, Watkins H, Neubauer S. Blunted myocardial oxygenation response during vasodilator stress in patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 2013 Mar 19;61(11):1169-76. doi: 10.1016/j.jacc.2012.12.024.
- Background: PubMed 17043737Padhani AR, Krohn KA, Lewis JS, Alber M. Imaging oxygenation of human tumours. Eur Radiol. 2007 Apr;17(4):861-72. doi: 10.1007/s00330-006-0431-y. Epub 2006 Oct 17.
- Background: PubMed 7053127Young IR, Clarke GJ, Bailes DR, Pennock JM, Doyle FH, Bydder GM. Enhancement of relaxation rate with paramagnetic contrast agents in NMR imaging. J Comput Tomogr. 1981 Dec;5(6):543-7. doi: 10.1016/0149-936x(81)90089-8.
- Background: PubMed 20677232Kershaw LE, Naish JH, McGrath DM, Waterton JC, Parker GJ. Measurement of arterial plasma oxygenation in dynamic oxygen-enhanced MRI. Magn Reson Med. 2010 Dec;64(6):1838-42. doi: 10.1002/mrm.22571.
- Background: PubMed 19327904O'Connor JP, Naish JH, Parker GJ, Waterton JC, Watson Y, Jayson GC, Buonaccorsi GA, Cheung S, Buckley DL, McGrath DM, West CM, Davidson SE, Roberts C, Mills SJ, Mitchell CL, Hope L, Ton NC, Jackson A. Preliminary study of oxygen-enhanced longitudinal relaxation in MRI: a potential novel biomarker of oxygenation changes in solid tumors. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1209-15. doi: 10.1016/j.ijrobp.2008.12.040. Epub 2009 Mar 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Miller, MBChB, MRCP principal investigator
Manchester University NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To apply OE-MRI in the heart and compare it to BOLD imaging (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05163327, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.