Cardiovascular Diseases, COVID19
Conditions
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.
Interventions
DIAGNOSTIC_TESTNon-invasive cardiac imaging
Cardiac MRI ± CT coronary angiography ± Cardiac PET/MRI (68Ga-DOTATATE or 18F-FDG)
Sponsors
Cambridge University Hospitals NHS Foundation Trust
British Heart Foundation
Wellcome Trust
University of Cambridge
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis | 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
| Measure | Time frame | Description |
|---|---|---|
| Immune markers | Baseline | Comparison of a panel of inflammatory cytokines and immune cell profiles in patients stratified by cardiac diagnosis/imaging findings |
| Coagulation markers | Baseline | Comparison of a panel of blood coagulation markers in patients stratified by cardiac diagnosis/imaging findings |
Countries
United Kingdom
Outcome results
None listed