Skip to main content
Clinical Trials/NCT04412369
NCT04412369
Completed
Not Applicable

Multi-modality Imaging & Immunophenotyping of COVID-19 Related Myocardial Injury

University of Cambridge1 site in 1 country21 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID19
Sponsor
University of Cambridge
Enrollment
21
Locations
1
Primary Endpoint
Diagnosis
Status
Completed
Last Updated
last year

Overview

Brief Summary

Cardiovascular involvement in coronavirus disease-2019 (COVID-19) encompasses a wide range of vascular and myocardial pathologies, including both acute and long-term sequelae. The MIIC-MI study aims to investigate mechanisms of cardiac injury in COVID-19 using multi-modality imaging and immunophenotyping to better understand the link with adverse patient outcomes.

Detailed Description

Cardiovascular involvement in coronavirus disease-2019 (COVID-19) encompasses a wide range of vascular and myocardial pathologies, including both acute and long-term sequelae. Cardiac Troponin elevation, a marker of acute myocardial injury, has been identified in up to 28% of hospitalized patients with coronavirus disease 2019 (COVID-19) and is associated with an increased mortality risk. However, the predominant aetiology of myocardial injury relating to COVID-19 remains unclear. The Troponin leak could either signify direct cardiac involvement in COVID-19 or serve as a non-specific marker of a severe systemic insult. There have been numerous reports of acute myocarditis in patients with COVID-19. Other contributory mechanisms of cardiac Troponin elevation in patients with COVID-19 that are also driven by a proinflammatory state include acute myocardial infarction due to atherosclerotic plaque rupture (type 1) or demand ischemia (type 2), endothelial and microvascular dysfunction, immune-mediated activation of coagulation and fibrinolytic systems, and stress cardiomyopathy. Longer-term effects of COVID-19 on the cardiovascular system are also unknown. Many individuals with post-acute sequalae of SARS-CoV-2 infection (or 'long COVID') have unexplained cardiac symptoms. Patients may also present with new-onset heart failure after COVID-19, which is not attributed to another cause. We aim to identify patterns of myocardial injury in COVID-19 using non-invasive multi-modality cardiac imaging, paired with cytokine/chemokine testing, immunophenotyping of peripheral blood cells and coagulation profiles. A better understanding of the mechanisms underlying the excess mortality risk attributable to myocardial injury in COVID-19 is needed and may help to improve patient care.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
August 1, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jason Tarkin

Wellcome Clinical Research Career Development Fellow

University of Cambridge

Eligibility Criteria

Inclusion Criteria

  • Patients \>18 years old
  • Confirmed COVID-19 infection AND Troponin I elevation \>99th percentile of upper reference limit OR new-onset heart failure OR unexplained cardiac symptoms
  • Able to give written, informed consent

Exclusion Criteria

  • Women of child-bearing potential not using adequate contraception
  • Contra-indication to MRI scanning
  • Contrast allergy or contrast-nephropathy
  • Chronic kidney disease (eGFR \<30 mL/min/1.73 m2)
  • Previous myocardial infarction
  • Uncontrolled atrial fibrillation
  • Uncontrolled chronic inflammatory disease
  • Severe lymphopenia (\<0.2 x109/L)
  • Treatment with immunomodulatory therapies within the last month (excluding inhaled or topical steroid therapy)
  • Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study

Outcomes

Primary Outcomes

Diagnosis

Time Frame: Baseline

Number of participants with a diagnosis of COVID-19 related myocarditis, Type 1 or 2 myocardial infarction and/or other mechanism of cardiac injury confirmed by multi-modality imaging.

Secondary Outcomes

  • Coagulation markers(Baseline)
  • Immune markers(Baseline)

Study Sites (1)

Loading locations...

Similar Trials