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Completed

NCT Number: NCT04412369

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cambridge Univeristy Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive cardiac imaging

Diagnostic Test

Cardiac MRI ± CT coronary angiography ± Cardiac PET/MRI (68Ga-DOTATATE or 18F-FDG)

Primary outcomes

  1. 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

  1. Immune markers

    Time frame: Baseline

    Comparison of a panel of inflammatory cytokines and immune cell profiles in patients stratified by cardiac diagnosis/imaging findings

  2. Coagulation markers

    Time frame: Baseline

    Comparison of a panel of blood coagulation markers in patients stratified by cardiac diagnosis/imaging findings

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Collaborators

  • British Heart Foundation
  • Cambridge University Hospitals NHS Foundation Trust
  • Wellcome Trust

Registry information

Acronym: MIIC-MI

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 2, 2020
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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