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

Cardiovascular Diseases Clinical Trial

— MIIC-MI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04412369
• Other study ID #: A09565
• Status: Active, not recruiting
• Start date: July 1, 2020
• Est. completion date: August 2023

Study information

• Verified date: March 2023
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• COVID-19
• COVID19

Intervention

Diagnostic Test:
• Non-invasive cardiac imaging
Cardiac MRI ± CT coronary angiography ± Cardiac PET/MRI (68Ga-DOTATATE or 18F-FDG)

Locations

Country	Name	City	State
United Kingdom	Cambridge Univeristy Hospitals NHS Foundation Trust	Cambridge

Sponsors (4)

Lead Sponsor	Collaborator
University of Cambridge	British Heart Foundation, Cambridge University Hospitals NHS Foundation Trust, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis	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.	Baseline
Secondary	Immune markers	Comparison of a panel of inflammatory cytokines and immune cell profiles in patients stratified by cardiac diagnosis/imaging findings	Baseline
Secondary	Coagulation markers	Comparison of a panel of blood coagulation markers in patients stratified by cardiac diagnosis/imaging findings	Baseline