Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium (NCT03607669) | Clinical Trial Compass
CompletedNot Applicable
Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium
United Kingdom90 participantsStarted 2018-06-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
• 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
Exclusion Criteria:
* have a positive pregnancy test
* women who are breast feeding
* received an inve…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.