Heart Diseases, IschemicNCT03618303
PET-MR Imaging of Coronary Atherothrombosis
A study testing PET-MRI scan in people with Heart Diseases, Ischemic, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Heart attacks remain a common cause of death throughout the world. The most common initiating event is the formation of a blood clot within the coronary arteries occluding blood supply to the heart. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Diseases, Ischemic
- What is being tested?
- PET-MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jul 2018to 24 Mar 2020
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously diagnosed coronary artery disease undergoing elective invasive angiography OR
- Admitted with acute coronary syndrome diagnosed by two of the following criteria 1) Elevation of cardiac biomarkers (High sensitivity cardiac troponin I greater than 34 ng/l in men and 16ng/l in women) 2) Symptoms of myocardial ischaemia 3) ECG changes indicative of acute ischaemia
Who cannot join
- Contraindication or inability to undergo MRI scanning
- Renal failure (estimated glomerular filtration rate less than 30mL/min
- Undergoing Primary PCI
- Ongoing myocardial ischaemia or dynamic ECG changes
- Inability to provide informed consent
- Known allergy to gadolinium based contrast
- Women who are pregnant, breastfeeding or of child-bearing potential
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's Medical Research Institute
Edinburgh, Scotland, EH16 4SB
About this study
Official title: Combined Positron Emission Tomography and Magnetic Resonance Imaging of Coronary Atherothrombosis
Heart attacks remain a common cause of death throughout the world. The most common initiating event is the formation of a blood clot within the coronary arteries occluding blood supply to the heart. However, we know that thrombus often occurs within the coronary arteries without causing any symptoms, and may be found in patients with stable angina. We wish to investigate whether blood clots within the coronary arteries can be detected in patients who have had a heart attack and in patients with stable angina using combined positron emission tomography and magnetic resonance (PET-MR) imaging. If possible, this may provide a safe and noninvasive means of identifying patients at higher risk of heart attacks.
The study will be conducted in Edinburgh Heart Centre and a total of 40 participants will be recruited from the cardiology wards, outpatient clinics and day case unit. Participants will be asked to undergo a single PET-MRI scan in addition to invasive angiography as part of standard care (non-research procedure). During the invasive angiogram procedure, an additional imaging test may be performed called Optical Coherence Tomography to provide images from within the heart blood vessels.
- Conditions
- Heart Diseases, Ischemic
- Being tested
- PET-MRI scan
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRI scanDiagnostic test
Also called Optical Coherence Tomography
Patients will undergo combined Positron Emission Tomography and Magnetic Resonance Imaging prior to a planned invasive angiogram (performed as standard of care). During the angiogram procedure, an additional imaging test (optical coherence tomography) will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | All patients will undergo the same intervention of having a PET-MRI scan and optical coherence tomography. Receives: Diagnostic Test: PET-MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque-to-myocardial ratio of culprit plaques on T1-weighted imaging
The identification of high risk plaques on T1-weighted MRI to determine whether coronary atherothrombosis can accurately be detected using non-invasive PET-MR imaging.
Measured: Baseline
Secondary outcomes (2)
The correlation between high risk plaques on PET-MR and culprit plaques on invasive angiography in patients with coronary artery disease.
The relationship between positive plaques identified on PET-MR by both T1-weighted MRI and 18F-NaF PET and culprit plaques on invasive angiography
Measured: Baseline
The correlation between coronary plaque thrombosis (MRI), high-risk plaque (PET) and the presence of myocardial infarction on MRI (late enhancement).
The relationship between high risk plaque features on MRI and PET with evidence of myocardial infarction on MRI.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start16 Jul 2018
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Diseases, IschemicStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mhairi K Doris, MBChB, Principal investigator, University of EdinburghDavid E Newby, PhD DM DSc, Study chair, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618303
- Sponsor's protocol ID
- AC17091
- Status last verified
- May 2024
- First submitted
- 31 Jul 2018
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xie Y, Kim YJ, Pang J, Kim JS, Yang Q, Wei J, Nguyen CT, Deng Z, Choi BW, Fan Z, Bairey Merz CN, Shah PK, Berman DS, Chang HJ, Li D. Coronary Atherosclerosis T1-Weighed Characterization With Integrated Anatomical Reference: Comparison With High-Risk Plaque Features Detected by Invasive Coronary Imaging. JACC Cardiovasc Imaging. 2017 Jun;10(6):637-648. doi: 10.1016/j.jcmg.2016.06.014. Epub 2016 Oct 12.
PubMed 27743950Noguchi T, Kawasaki T, Tanaka A, Yasuda S, Goto Y, Ishihara M, Nishimura K, Miyamoto Y, Node K, Koga N. High-intensity signals in coronary plaques on noncontrast T1-weighted magnetic resonance imaging as a novel determinant of coronary events. J Am Coll Cardiol. 2014 Mar 18;63(10):989-99. doi: 10.1016/j.jacc.2013.11.034. Epub 2013 Dec 15.
PubMed 24345595Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11.
PubMed 24224999Matsumoto K, Ehara S, Hasegawa T, Sakaguchi M, Otsuka K, Yoshikawa J, Shimada K. Localization of Coronary High-Intensity Signals on T1-Weighted MR Imaging: Relation to Plaque Morphology and Clinical Severity of Angina Pectoris. JACC Cardiovasc Imaging. 2015 Oct;8(10):1143-1152. doi: 10.1016/j.jcmg.2015.06.013. Epub 2015 Sep 9.
PubMed 26363839
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Positron Emission Tomography and Magnetic Resonance Imaging of Coronary Atherothrombosis
- ClinicalTrials.gov ID
- NCT03618303
- Acronym / sponsor ID
- AC17091
- Conditions
- Heart Diseases, Ischemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 7 Aug 2018 (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.
Heart attacks remain a common cause of death throughout the world. The most common initiating event is the formation of a blood clot within the coronary arteries occluding blood supply to the heart. However, we know that thrombus often occurs within the coronary arteries without causing any symptoms, and may be found in patients with stable angina. We wish to investigate whether blood clots within the coronary arteries can be detected in patients who have had a heart attack and in patients with stable angina using combined positron emission tomography and magnetic resonance (PET-MR) imaging. If possible, this may provide a safe and noninvasive means of identifying patients at higher risk of heart attacks.
The study will be conducted in Edinburgh Heart Centre and a total of 40 participants will be recruited from the cardiology wards, outpatient clinics and day case unit. Participants will be asked to undergo a single PET-MRI scan in addition to invasive angiography as part of standard care (non-research procedure). During the invasive angiogram procedure, an additional imaging test may be performed called Optical Coherence Tomography to provide images from within the heart blood vessels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Diagnostic Test: PET-MRI scanAll patients will undergo the same intervention of having a PET-MRI scan and optical coherence tomography. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previously diagnosed coronary artery disease undergoing elective invasive angiography OR
- Admitted with acute coronary syndrome diagnosed by two of the following criteria 1) Elevation of cardiac biomarkers (High sensitivity cardiac troponin I greater than 34 ng/l in men and 16ng/l in women) 2) Symptoms of myocardial ischaemia 3) ECG changes indicative of acute ischaemia
Key exclusion criteria (7 listed)
- Contraindication or inability to undergo MRI scanning
- Renal failure (estimated glomerular filtration rate less than 30mL/min
- Undergoing Primary PCI
- Ongoing myocardial ischaemia or dynamic ECG changes
- Inability to provide informed consent
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 |
|---|---|---|
| PET-MRI scanAlso: Optical Coherence TomographyPatients will undergo combined Positron Emission Tomography and Magnetic Resonance Imaging prior to a planned invasive angiogram (performed as standard of care). During the angiogram procedure, an additional imaging test (optical coherence tomography) will be performed. | Diagnostic test | Interventional |
Primary outcome
Plaque-to-myocardial ratio of culprit plaques on T1-weighted imaging
Time frame: Baseline
The identification of high risk plaques on T1-weighted MRI to determine whether coronary atherothrombosis can accurately be detected using non-invasive PET-MR imaging.
2 secondary outcomes
The correlation between high risk plaques on PET-MR and culprit plaques on invasive angiography in patients with coronary artery disease.
Time frame: Baseline
The correlation between coronary plaque thrombosis (MRI), high-risk plaque (PET) and the presence of myocardial infarction on MRI (late enhancement).
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 27743950Xie Y, Kim YJ, Pang J, Kim JS, Yang Q, Wei J, Nguyen CT, Deng Z, Choi BW, Fan Z, Bairey Merz CN, Shah PK, Berman DS, Chang HJ, Li D. Coronary Atherosclerosis T1-Weighed Characterization With Integrated Anatomical Reference: Comparison With High-Risk Plaque Features Detected by Invasive Coronary Imaging. JACC Cardiovasc Imaging. 2017 Jun;10(6):637-648. doi: 10.1016/j.jcmg.2016.06.014. Epub 2016 Oct 12.
- Background: PubMed 24345595Noguchi T, Kawasaki T, Tanaka A, Yasuda S, Goto Y, Ishihara M, Nishimura K, Miyamoto Y, Node K, Koga N. High-intensity signals in coronary plaques on noncontrast T1-weighted magnetic resonance imaging as a novel determinant of coronary events. J Am Coll Cardiol. 2014 Mar 18;63(10):989-99. doi: 10.1016/j.jacc.2013.11.034. Epub 2013 Dec 15.
- Background: PubMed 24224999Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11.
- Background: PubMed 26363839Matsumoto K, Ehara S, Hasegawa T, Sakaguchi M, Otsuka K, Yoshikawa J, Shimada K. Localization of Coronary High-Intensity Signals on T1-Weighted MR Imaging: Relation to Plaque Morphology and Clinical Severity of Angina Pectoris. JACC Cardiovasc Imaging. 2015 Oct;8(10):1143-1152. doi: 10.1016/j.jcmg.2015.06.013. Epub 2015 Sep 9.
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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.
Mhairi K Doris, MBChB principal investigator
University of Edinburgh
David E Newby, PhD DM DSc study chair
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MRI scan in people with Heart Diseases, Ischemic, run by University of Edinburgh 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 21 May 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plaque-to-myocardial ratio of culprit plaques on T1-weighted imaging (time frame: Baseline). 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 NCT03618303, which also lists 4 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 21 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.