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

NCT04625075 | Completed DMC

• 1 other identifier: 20/NW/0249
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

• MRI with gadolinium

  Measure late gadolinium enhancement

  2 years

• Extra-cellular volume (ECV)

  Measure T1 values to calculate ECV (%)

  2 years

• Manganese MRI

  Measure manganese uptake

  2 years

• CTCA

  Measure degree of coronary disease

  2 years

Secondary Outcomes (6)

• Cardiac biomarkers

  2 years

• Electrocardiogram

  2 years

• Electrocardiogram

  2 years

• Electrocardiogram

  2 years

• Electrocardiogram

  2 years

Study Arms (3)

Healthy Volunteer

Age and sex matched healthy volunteer

Diagnostic Test: Cardiac MRI; Diagnostic Test: Electrocardiogram (ECG); Diagnostic Test: Blood samples

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; Diagnostic Test: Cardiac CT; Diagnostic Test: Electrocardiogram (ECG); Diagnostic Test: Blood samples

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; Diagnostic Test: Cardiac CT; Diagnostic Test: Electrocardiogram (ECG); Diagnostic Test: Blood samples

Interventions

Cardiac MRI DIAGNOSTIC_TEST

Cardiac MRI with gadolinium and manganese contrast

COVID-19 with myocardial injury; COVID-19 without myocardial injury; Healthy Volunteer

Cardiac CT DIAGNOSTIC_TEST

Cardiac CT to assess coronaries

COVID-19 with myocardial injury; COVID-19 without myocardial injury

Electrocardiogram (ECG) DIAGNOSTIC_TEST

ECG to assess rhythm

COVID-19 with myocardial injury; COVID-19 without myocardial injury; Healthy Volunteer

Blood samples DIAGNOSTIC_TEST

renal function liver function full blood count, hematocrit glucose

COVID-19 with myocardial injury; COVID-19 without myocardial injury; Healthy Volunteer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, Scotland, EH146SB, United Kingdom

Location

Related Publications (1)

• Singh T, Kite TA, Joshi SS, Spath NB, Kershaw L, Baker A, Jordan H, Gulsin GS, Williams MC, van Beek EJR, Arnold JR, Semple SIK, Moss AJ, Newby DE, Dweck M, McCann GP. MRI and CT coronary angiography in survivors of COVID-19. Heart. 2022 Jan;108(1):46-53. doi: 10.1136/heartjnl-2021-319926. Epub 2021 Oct 6.

  PMID: 34615668 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Electrocardiography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 12, 2020
• Study Start: June 10, 2020
• Primary Completion: June 10, 2021
• Study Completion: February 3, 2022
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)