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Sponsor study identifier
observational
90
1 country
1
Study Start
June 1, 2018
Actual (reported)Primary Completion
February 1, 2020
Actual (reported)Study Completion
February 1, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2018
Actual (reported)July 20, 2018
Actual (reported)July 31, 2018
Actual (reported)February 1, 2020
Actual (reported)February 1, 2020
Actual (reported)Myocardial calcium-handling
Quantification of myocardial calcium handling by T1 mapping, in healthy controls, and patient groups.
1 year
Myocardial infarction quantification
1 year
Healthy volunteers of similar age and gender
Patients with ischaemic cardiomyopathy and NYHA II-III heart failure
Patients with hypertrophic cardiomyopathy and NYHA II-III heart failure
Patients with dilated cardiomyopathy and NYHA II-III heart failure
Manganese-based MRI contrast agent
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Queen's Medical Research Institute, University of Edinburgh
Edinburgh, Midlothian, EH16 4TJ, United Kingdom
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.
David E Newby, MD PhD
University of Edinburgh
90 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2018
First Posted
July 31, 2018
Study Start
June 1, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 1, 2020
Actual (reported)Study Completion
February 1, 2020
Actual (reported)Last Updated
May 17, 2024
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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