NCT04412369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

2.4 years

First QC Date

May 27, 2020

Last Update Submit

July 18, 2024

Conditions

COVID19Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Immune markers

    Baseline

  • Coagulation markers

    Baseline

Study Arms (1)

Study group

Patients with COVID-19 and cardiac Troponin elevation

Diagnostic Test: Non-invasive cardiac imaging

Interventions

Non-invasive cardiac imagingDIAGNOSTIC_TEST

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

Study group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a history of COVID-19 and cardiovascular involvement

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge Univeristy Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (1)

  • Corovic A, Zhao X, Huang Y, Newland SR, Gopalan D, Harrison J, Giakomidi D, Chen S, Yarkoni NS, Wall C, Peverelli M, Sriranjan R, Gallo A, Graves MJ, Sage A, Lyons PA, Sithole N, Bennett MR, Rudd JHF, Mallat Z, Zhao TX, Nus M, Tarkin JM. Coronavirus disease 2019-related myocardial injury is associated with immune dysregulation in symptomatic patients with cardiac magnetic resonance imaging abnormalities. Cardiovasc Res. 2024 Nov 25;120(14):1752-1767. doi: 10.1093/cvr/cvae159.

    PMID: 39073768DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

COVID-19Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jason M Tarkin, MBBS, PhD

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wellcome Clinical Research Career Development Fellow

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 2, 2020

Study Start

July 1, 2020

Primary Completion

December 1, 2022

Study Completion

August 1, 2023

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations

GB(1)