Clinical trial NCT04412369: Multi-modality Imaging & Immunophenotyping of COVID-19 Related Myocardial Injury
Official title: Multi-modality Imaging & Immunophenotyping of COVID-19 Related Myocardial Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID19
Cardiovascular Diseases
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
name: British Heart Foundation
name: Wellcome Trust
First posted: 2020-06-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a history of COVID-19 and cardiovascular involvement

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.

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

Primary outcomes:
measure: Diagnosis
timeFrame: Baseline
Secondary outcomes:
measure: Immune markers
timeFrame: Baseline
measure: Coagulation markers
timeFrame: Baseline
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge Univeristy Hospitals NHS Foundation Trust
Study officials:
affiliation: University of Cambridge
name: Jason M Tarkin, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: