Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium

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Brief Title

Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium

Official Title

Manganese-Enhanced Magnetic Resonance Imaging: Applications in Cardiomyopathy

Brief 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.
    



Study Type

Observational


Primary Outcome

Myocardial calcium-handling

Secondary Outcome

 Myocardial infarction quantification

Condition

Ischemic Cardiomyopathy

Intervention

Mangafodipir trisodium

Study Arms / Comparison Groups

 Healthy Controls
Description:  Healthy volunteers of similar age and gender

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

90

Start Date

June 1, 2018

Completion Date

December 31, 2019

Primary Completion Date

July 31, 2019

Eligibility Criteria

        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 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

          -  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),
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

David E Newby, MD PhD, 0131 242 6515, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03607669

Organization ID

AC16109


Responsible Party

Sponsor

Study Sponsor

University of Edinburgh


Study Sponsor

David E Newby, MD PhD, Study Director, University of Edinburgh


Verification Date

May 2018