Manganese-Enhanced Magnetic Resonance Imaging (MEMRI) in Ischaemic, Inflammatory and Takotsubo Ca… (NCT04623788) | Clinical Trial Compass
CompletedNot Applicable
Manganese-Enhanced Magnetic Resonance Imaging (MEMRI) in Ischaemic, Inflammatory and Takotsubo Cardiomyopathy (MEMORY)
United Kingdom51 participantsStarted 2020-02-20
Plain-language summary
Manganese is a calcium analogue which actively enters viable cells with intact calcium-handling mechanisms and its uptake is evident by an increase in MRI-detectable T1 relaxivity of tissues. Mangafodipir is a novel manganese-based magnetic resonance imaging (MRI) contrast medium with unique biophysical properties that are ideal for application to cardiac imaging. Recent studies in man have demonstrated the utility of manganese-enhanced MRI (MEMRI) in assessing infarct size more accurately than with standard cardiac MRI protocols using gadolinium enhancement and have shown reduced myocardial manganese uptake in patients with cardiomyopathies suggesting abnormal calcium handling.
Understanding the potential for myocardial recovery is key in guiding revascularisation therapies in ischaemic cardiomyopathy, in addition to novel therapies used in heart failure. Being able to monitor calcium handling and therefore myocardial function in different types of cardiomyopathies has the potential to guide management in these patients. The investigators here propose an investigational observational study of MEMRI to assess myocardial calcium handling in reversible causes of cardiomyopathy, namely ischaemic cardiomyopathy, myocarditis and takotsubo cardiomyopathy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
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:
Cohort 1
• Healthy adult with no known pre-existing medical conditions
Cohort 2
* Positive stress- akinesia/hypokinesis on pharmacological stress
* Negative stress- no inducible regional wall motion abnormalities on pharmacological stress
Cohort 3
* New left/right ventricular dysfunction; including regional wall motion abnormalities (RWMA's)
* New abnormal ECG findings (conduction, atrio-ventricular block, ST/T wave changes)
* Raised biomarkers (troponin, TnI)
* Tissue characteristics on MRI (myocardial oedema and typical late gadolinium enhancement pattern)
Cohort 4
* Normal/ Non-obstructive coronaries on angiography
* Typical RWMA's based on echocardiography, MRI or left ventriculography
Exclusion Criteria:
* The following apply to all participants:
* 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 a history of ongoing drug abuse or alcoholism
* have a history of torsades or prolonged QT/QT corrected interval
* high degree atrioventricular block (second or third degree)
* atrial fibrillati…
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.