Ischemic CardiomyopathyNCT03607669
Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium
An observational study of Ischemic Cardiomyopathy and Dilated Cardiomyopathy, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Scanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function. MRI can give more detailed information about the heart by using a contrast 'dye' that is injected into a vein during the scan. This can highlight abnormal areas within the heart. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy
- What is being tested?
- Mangafodipir trisodium
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2018to 1 Feb 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attending the Edinburgh Heart Centre will be invited to participate. Inpatients and outpatients are eligible. Healthy volunteers will be invited to participate by local recruitment.
Who may be able to join
- All subjects to be entered must:
- ≥ 18 years of age
- if female, be non-pregnant as evidenced by a urine pregnancy test or post-menopausal or surgically sterile
- provide written informed consent after having received oral and written information about the study
- Additionally, cohort-specific inclusion criteria as follows:
- Healthy Volunteers
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- Healthy adult with no known pre-existing medical conditions
- Ischaemic Cardiomyopathy
- Ischaemic cardiomyopathy as diagnosed by reduced LV ejection fraction (≤40%) secondary to one or more ischaemic events
- Angiographically demonstrated LMS, LAD disease, or ≥2 vessel disease
- NHYA class I-III heart failure, with stable symptoms not requiring change to diuretic therapy in the preceding month
- Dilated Cardiomyopathy
- Dilated cardiomyopathy characterised with echocardiography by reduced left ventricular systolic function with impaired systolic function (ejection fraction <40%).
- NHYA class I-III heart failure, with stable symptoms not requiring change to diuretic therapy in the preceding month
- Hypertrophic Cardiomyopathy
- Established diagnosis of hypertrophic cardiomyopathy
- Left ventricular wall thickness ≥15mm in any segment
- Repolarisation abnormalities on 12-lead electrocardiogram NHYA class I-III heart failure, with stable symptoms not requiring change to diuretic therapy in the preceding month
Who cannot join
- have a positive pregnancy test
- women who are breast feeding
- received an investigational drug or device within 30 days prior to administration of Mangafodipir
- have known hypersensitivity to ondansetron or other selective serotonin 5-HT3 receptor blockers
- have a history of ongoing drug abuse or alcoholism
- have a history of torsades or prolonged QT/QTc interval
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- atrioventricular block (1st, 2nd or 3rd degree)
- atrial fibrillation or flutter
- have NYHA Grade IV heart failure
- have abnormal liver function tests or a history of liver disease
- have a baseline eGFR (estimated glomerular filtration rate) of <30 mL/min)
- have uncontrolled hypertension
- have any contraindications to MRI, including implanted devices/pacemakers
- be maintained on either a calcium channel blocker or digoxin
- known diagnosis of phaeochromocytoma
- Additionally, cohort-specific exclusion criteria as follows:
- Hypertrophic Cardiomyopathy
- Coronary artery stenosis >50% any vessel
- Previous myocardial infarction
- Previous alcohol septal ablation
- Moderate or severe aortic stenosis (mean gradient >25 mmHg, mean AVA ≤1.5 cm2 or peak velocity ≥3 m/sec),
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's Medical Research Institute, University of Edinburgh
Edinburgh, Midlothian, EH16 4TJ
About this study
Official title: Manganese-Enhanced Magnetic Resonance Imaging: Applications in Cardiomyopathy
Scanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function. MRI can give more detailed information about the heart by using a contrast 'dye' that is injected into a vein during the scan. This can highlight abnormal areas within the heart. Current contrast dyes help identify scarring within the heart, which is useful in people who have had heart attacks. The investigators plan to test new contrast dye containing manganese, which works differently to current agents. They believe it will provide unique insight into how the heart works.
There are many different causes of heart problems and the investigators plan to use this new contrast agent to scan three patient groups; (i) heart disease caused by heart attacks, (ii) heart disease with abnormal thickening of the heart muscle, and (iii) heart disease where the heart becomes stretched and enlarged. Healthy volunteers will be scanned for comparison.
Read more
The study will be carried out at the Royal Infirmary of Edinburgh. Adults between 18 and 65 with stable heart failure can be considered. Women who may be pregnant are unable to participate, as is anyone who has some types of metal in their body, as these people can't have an MRI scan safely. All participants will have 2 MRI scans lasting about an hour each, at least 2 days apart. Some participants will be have 4 MRI scans, over a longer time period. The investigators will also take some blood samples and record a tracing of the heart rhythm and will ensure there are no abnormal side-effects by telephone follow up.
The investigators believe this new agent has potential to better measure disease in the heart, improve the ability to establish the cause of heart disease and help monitor the disease over time as well as guide future treatment for individual patients.
- Being tested
- Mangafodipir trisodium
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mangafodipir trisodiumOther
Manganese-based MRI contrast agent
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy volunteers of similar age and gender Receives: Other: Mangafodipir trisodium | |
| Ischaemic Cardiomyopathy | Patients with ischaemic cardiomyopathy and NYHA II-III heart failure Receives: Other: Mangafodipir trisodium | |
| Hypertrophic Cardiomyopathy | Patients with hypertrophic cardiomyopathy and NYHA II-III heart failure Receives: Other: Mangafodipir trisodium | |
| Dilated Cardiomyopathy | Patients with dilated cardiomyopathy and NYHA II-III heart failure Receives: Other: Mangafodipir trisodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial calcium-handling
Quantification of myocardial calcium handling by T1 mapping, in healthy controls, and patient groups.
Measured: 1 year
Secondary outcomes (1)
Myocardial infarction quantification
Quantification of infarct size using manganese, and comparison with Gadolinium enhanced MRI.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Jun 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic CardiomyopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David E Newby, MD PhD, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607669
- Sponsor's protocol ID
- AC16109
- Status last verified
- May 2024
- First submitted
- 20 Jul 2018
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spath NB, Singh T, Papanastasiou G, Baker A, Janiczek RJ, McCann GP, Dweck MR, Kershaw L, Newby DE, Semple S. Assessment of stunned and viable myocardium using manganese-enhanced MRI. Open Heart. 2021 Jun;8(1):e001646. doi: 10.1136/openhrt-2021-001646.
PubMed 34099530
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manganese-Enhanced Magnetic Resonance Imaging: Applications in Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03607669
- Acronym / sponsor ID
- AC16109
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 31 Jul 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.
Scanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function. MRI can give more detailed information about the heart by using a contrast 'dye' that is injected into a vein during the scan. This can highlight abnormal areas within the heart. Current contrast dyes help identify scarring within the heart, which is useful in people who have had heart attacks. The investigators plan to test new contrast dye containing manganese, which works differently to current agents. They believe it will provide unique insight into how the heart works.
There are many different causes of heart problems and the investigators plan to use this new contrast agent to scan three patient groups; (i) heart disease caused by heart attacks, (ii) heart disease with abnormal thickening of the heart muscle, and (iii) heart disease where the heart becomes stretched and enlarged. Healthy volunteers will be scanned for comparison.
The study will be carried out at the Royal Infirmary of Edinburgh. Adults between 18 and 65 with stable heart failure can be considered. Women who may be pregnant are unable to participate, as is anyone who has some types of metal in their body, as these people can't have an MRI scan safely. All participants will have 2 MRI scans lasting about an hour each, at least 2 days apart. Some participants will be have 4 MRI scans, over a longer time period. The investigators will also take some blood samples and record a tracing of the heart rhythm and will ensure there are no abnormal side-effects by telephone follow up.
The investigators believe this new agent has potential to better measure disease in the heart, improve the ability to establish the cause of heart disease and help monitor the disease over time as well as guide future treatment for individual patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Other: Mangafodipir trisodiumHealthy volunteers of similar age and gender |
| Ischaemic Cardiomyopathy | – | Other: Mangafodipir trisodiumPatients with ischaemic cardiomyopathy and NYHA II-III heart failure |
| Hypertrophic Cardiomyopathy | – | Other: Mangafodipir trisodiumPatients with hypertrophic cardiomyopathy and NYHA II-III heart failure |
| Dilated Cardiomyopathy | – | Other: Mangafodipir trisodiumPatients with dilated cardiomyopathy and NYHA II-III heart failure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the Edinburgh Heart Centre will be invited to participate. Inpatients and outpatients are eligible. Healthy volunteers will be invited to participate by local recruitment.
Key inclusion criteria (18 listed)
- ≥ 18 years of age
- if female, be non-pregnant as evidenced by a urine pregnancy test or post-menopausal or surgically sterile
- provide written informed consent after having received oral and written information about the study
- Healthy Volunteers
- Healthy adult with no known pre-existing medical conditions
Key exclusion criteria (21 listed)
- have a positive pregnancy test
- women who are breast feeding
- received an investigational drug or device within 30 days prior to administration of Mangafodipir
- have known hypersensitivity to ondansetron or other selective serotonin 5-HT3 receptor blockers
- have a history of ongoing drug abuse or alcoholism
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 |
|---|---|---|
| Mangafodipir trisodiumManganese-based MRI contrast agent | Other | Dilated Cardiomyopathy, Healthy Controls, Hypertrophic Cardiomyopathy, Ischaemic Cardiomyopathy |
Primary outcome
Myocardial calcium-handling
Time frame: 1 year
Quantification of myocardial calcium handling by T1 mapping, in healthy controls, and patient groups.
1 secondary outcome
Myocardial infarction quantification
Time frame: 1 year
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 17 May 2024.
- Derived from this study: PubMed 34099530Spath NB, Singh T, Papanastasiou G, Baker A, Janiczek RJ, McCann GP, Dweck MR, Kershaw L, Newby DE, Semple S. Assessment of stunned and viable myocardium using manganese-enhanced MRI. Open Heart. 2021 Jun;8(1):e001646. doi: 10.1136/openhrt-2021-001646.
- 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.
David E Newby, MD PhD study director
University of Edinburgh
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 Ischemic Cardiomyopathy and Dilated Cardiomyopathy, 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 18 inclusion and 21 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 17 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?
Myocardial calcium-handling (time frame: 1 year). 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 NCT03607669, which also lists 1 linked publication.
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 17 May 2024.