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Manganese-Enhanced Magnetic Resonance Imaging of MyOcardial injuRY in COVID 19 (COVID-19) (MEMORY-COVID)

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ClinicalTrials.gov Identifier: NCT04625075
Recruitment Status : Active, not recruiting
First Posted : November 12, 2020
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:

Our understanding of the clinical manifestations of COVID-19 is growing on a daily basis and there is evidence that increased age, cardiovascular risk factors and cardiac comorbidity are strongly associated with poor outcomes. Furthermore, myocardial injury occurs and is associated with a much worse outcome and rapid increase in mortality. There have been several reports of myocarditis and heart failure following infection. The mechanisms of myocardial injury and its consequences are not well understood.

In an ongoing peer-reviewed and funded study, the investigators are evaluating the use of magnetic resonance imaging (MRI) to characterise and to understand the mechanisms of heart failure and myocarditis. Following strong encouragement by the British Heart Foundation, the investigators now propose to extend this investigation to patients who have recovered from COVID-19 infection to understand the mechanisms of myocardial injury that they have experienced. Using gadolinium and manganese-enhanced MRI combined with Computed tomography coronary angiography (CTCA), the investigators will assess the mechanisms and direct impact of myocardial injury in patients who have recovered from COVID-19 infection. This will help the investigators understand how best to manage individuals who demonstrate evidence of myocardial injury and potentially provide insights that could lead to novel treatment interventions to reduce such injury and improve patient outcomes.


Condition or disease Intervention/treatment
Covid19 Diagnostic Test: Cardiac MRI Diagnostic Test: Cardiac CT Diagnostic Test: Electrocardiogram (ECG) Diagnostic Test: Blood samples

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Manganese-Enhanced Magnetic Resonance Imaging of MyOcardial injuRY in COVID 19 (MEMORY- COVID)
Actual Study Start Date : June 10, 2020
Actual Primary Completion Date : June 10, 2021
Estimated Study Completion Date : June 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans Memory
Drug Information available for: Manganese

Group/Cohort Intervention/treatment
Healthy Volunteer
Age and sex matched healthy volunteer
Diagnostic Test: Cardiac MRI
Cardiac MRI with gadolinium and manganese contrast

Diagnostic Test: Electrocardiogram (ECG)
ECG to assess rhythm

Diagnostic Test: Blood samples
renal function liver function full blood count, hematocrit glucose

COVID-19 with myocardial injury
Patients hospitalised with severe COVID-19 infection and evidence of myocardial. Involvement: elevation of plasma cardiac troponin concentration (>99th centile of the upper reference limit), abnormalities on electrocardiography or abnormal echocardiography. Some patients will have suspected myocarditis or takotsubo cardiomyopathy. We will identify subgroups of interest who have left/right ventricular systolic dysfunction ± regional wall motion abnormalities, on echocardiography.
Diagnostic Test: Cardiac MRI
Cardiac MRI with gadolinium and manganese contrast

Diagnostic Test: Cardiac CT
Cardiac CT to assess coronaries

Diagnostic Test: Electrocardiogram (ECG)
ECG to assess rhythm

Diagnostic Test: Blood samples
renal function liver function full blood count, hematocrit glucose

COVID-19 without myocardial injury
Patients hospitalised with severe COVID-19 infection but without known elevation of plasma cardiac troponin concentration, clinically significant ECG abnormalities or an abnormal echocardiogram.
Diagnostic Test: Cardiac MRI
Cardiac MRI with gadolinium and manganese contrast

Diagnostic Test: Cardiac CT
Cardiac CT to assess coronaries

Diagnostic Test: Electrocardiogram (ECG)
ECG to assess rhythm

Diagnostic Test: Blood samples
renal function liver function full blood count, hematocrit glucose




Primary Outcome Measures :
  1. MRI with gadolinium [ Time Frame: 2 years ]
    Measure late gadolinium enhancement

  2. Extra-cellular volume (ECV) [ Time Frame: 2 years ]
    Measure T1 values to calculate ECV (%)

  3. Manganese MRI [ Time Frame: 2 years ]
    Measure manganese uptake

  4. CTCA [ Time Frame: 2 years ]
    Measure degree of coronary disease


Secondary Outcome Measures :
  1. Cardiac biomarkers [ Time Frame: 2 years ]
    measure troponin profile in patients

  2. Electrocardiogram [ Time Frame: 2 years ]
    ECG Rhythm

  3. Electrocardiogram [ Time Frame: 2 years ]
    ECG ST segment

  4. Electrocardiogram [ Time Frame: 2 years ]
    ECG Rate

  5. Electrocardiogram [ Time Frame: 2 years ]
    ECG T wave morphology

  6. Electrocardiogram [ Time Frame: 2 years ]
    ECG QT interval



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patient cohort:

Patients admitted to hospital with COVID-19 with and without myocardial injury

Healthy volunteer:

Age and sex matched healthy control with no evidence/symptoms of COVID-19

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 postmenopausal or surgically sterile
    • provide written informed consent after having received oral and written information about the study

Exclusion Criteria:

have a positive pregnancy test

  • women who are breast feeding
  • have a history of ongoing drug abuse or alcoholism
  • have a history of torsades or prolonged QT/QT corrected interval
  • high degree atrioventricular block (AVB, second or third degree)
  • atrial fibrillation or flutter
  • have New York Heart Failure Association (NYHA) Grade IV heart failure
  • have abnormal liver function tests (> x3 ULN) or a history of liver disease
  • have a baseline estimated glomerular filtration rate (eGFR) (of <30 mL/min/1.73 m2)
  • have uncontrolled hypertension (systolic blood pressure >200 mmHg)
  • have any contraindications to MRI, including implanted devices/pacemakers
  • be maintained on either a calcium channel blocker or digoxin
  • known diagnosis of pheochromocytoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625075


Locations
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United Kingdom
University of Edinburgh
Edinburgh, Scotland, United Kingdom, EH146SB
Sponsors and Collaborators
University of Edinburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT04625075    
Other Study ID Numbers: 20/NW/0249
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be directly shared with other researchers. Anonymised MRI data will be shared with Leeds university for a central MRI database of all COVID-19 patients.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases