MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients

NCT04525404 | Completed

• 1 other identifier: Pro00102389
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 2

Brief Summary

While many people with COVID-19 suffer from respiratory disease, there is growing evidence that the virus also affects other organs. The purpose of this study is to better understand the effects of COVID-19 on the lungs and other organs. The study investigators have developed new techniques in Magnetic Resonance Imaging (MRI) to scan the lungs, heart, brain and liver. The study investigators hope to learn more about how the virus causes inflammation in these organs and how this inflammation changes over time as people recover from COVID-19 illness. The study aims to enroll 228 people in Alberta. Participants will undergo one or more MRI scans and have blood testing at one or more time points to assess for inflammation, kidney function, liver function and possible heart injury. Participants will also undergo testing to assess sense of smell, cognition (thinking and memory), spirometry (breathing test for lung function) and and exercise tolerance (walk test). The study investigators hope this study will help us learn more about the long-term risks of COVID-19 disease.

Conditions

Covid19; Coronavirus Infection; SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

• Native myocardial T1 relaxation time

  Myocardial T1 is a surrogate marker of myocardial edema and the most sensitive MRI measure of acute myocarditis. We will show that myocardial T1 at baseline is significantly higher than myocardial T1 at 12 weeks follow-up. At 12 weeks, we will also compare native myocardial T1 in patients with baseline elevated troponin to those with baseline normal troponin as well as healthy controls

  12 weeks post COVID-19 diagnosis

Secondary Outcomes (6)

• FLAIR imaging

  12 weeks post COVID-19 diagnosis

• Compare 12-week cognitive testing to the corresponding findings on MRI of brain, heart and lung at baseline

  12 weeks post COVID-19 diagnosis

• Compare 12-week spirometry to the corresponding findings on MRI of brain, heart and lung at baseline

  12 weeks post COVID-19 diagnosis

• Compare 12-week walk test results to the corresponding findings on MRI of brain, heart and lung at baseline

  12 weeks post COVID-19 diagnosis

• Compare 12-week cognitive testing in patients with normal smell and/or normal appearing brainstem on MRI to patients with no or impaired smell and/or injury to brainstem on MRI

  12 weeks post COVID-19 diagnosis

Study Arms (2)

Troponin Substudy

Participants with new COVID-19 infection will undergo high-sensitivity Troponin testing; participants with elevated Troponin will undergo MRI, bloodwork, and olfaction testing at Baseline, then repeat MRI, bloodwork and all functional testing at the Recovered (ie 12weeks post diagnosis) phase. Participants with normal Troponin will undergo only olfaction testing and bloodwork at baseline, then MRI, bloodwork and all functional testing at the Recovered phase.

Diagnostic Test: MRI (heart, brain, lungs, liver); Diagnostic Test: Bloodwork; Other: Cognitive testing; Other: Olfaction testing; Diagnostic Test: Spirometry; Other: Walk Test

Late Cross-Sectional Substudy

Participants with a COVID-19 diagnosis at least 3 months prior to enrollment will undergo MRI, bloodwork and all functional testing at the Recovered phase only.

Diagnostic Test: MRI (heart, brain, lungs, liver); Diagnostic Test: Bloodwork; Other: Cognitive testing; Other: Olfaction testing; Diagnostic Test: Spirometry; Other: Walk Test

Interventions

MRI (heart, brain, lungs, liver) DIAGNOSTIC_TEST

MRI (heart, brain, lungs, liver)

Late Cross-Sectional Substudy; Troponin Substudy

Bloodwork DIAGNOSTIC_TEST

Serum biomarkers to assess systemic inflammation, renal function, cardiac injury, liver injury and steatosis, ACE-2 related peptides, cytokines, Activin A and autoantibodies to cardiac antigens, humoral cell RNA

Late Cross-Sectional Substudy; Troponin Substudy

Cognitive testing OTHER

NIH toolbox Cognitive Measures

Late Cross-Sectional Substudy; Troponin Substudy

Olfaction testing OTHER

Brief Smell Identification Test (BSIT)

Late Cross-Sectional Substudy; Troponin Substudy

Spirometry DIAGNOSTIC_TEST

Spirometry to evaluate forced expiratory volume in 1 second and forced vital capacity

Late Cross-Sectional Substudy; Troponin Substudy

Walk Test OTHER

Walk test to record overall distance walked in 6 minutes and time taken to walk the first 25 feet

Late Cross-Sectional Substudy; Troponin Substudy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with new or recent COVID-19 infection.

You may qualify if:

• years of age or older
• Willing and able to provide informed consent
• COVID-19 positive test (within 14 days of positive test date)
• High-sensitivity Troponin-I \>100ng/L or Troponin T \> 52ng/L
• Ability to obtain Baseline MRI imaging within 7 days (up to 14 days maximum) of Troponin result

You may not qualify if:

• Contraindication to MRI or MRI contrast
• GFR \< 30ml/kg/min/1.73m2
• Hemodynamic instability requiring inotropic agents
• Active ventilatory support
• years of age or older
• Willing and able to provide informed consent
• Previously diagnosed with COVID-19 \> 3 months ago
• Ability to obtain MRI imaging at minimum 12 weeks from COVID-19 diagnosis
• \. Contraindication to MRI or MRI contrast

Sponsors & Collaborators

• University of Alberta: lead
• Canadian VIGOUR Centre: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Related Publications (2)

• Paterson DI, White JA, Beaulieu C, Sherrington R, Prado CM, Tandon P, Halloran K, Smith S, McCombe JA, Ritchie B, Pituskin E, Haykowsky MJ, Coulden R, Emery D, Tsui AK, Wu KY, Oudit GY, Ezekowitz JA, Thompson RB. Rationale and design of the multi organ inflammation with serial testing study: a comprehensive assessment of functional and structural abnormalities in patients with recovered COVID-19. Front Med (Lausanne). 2024 Jul 24;11:1392169. doi: 10.3389/fmed.2024.1392169. eCollection 2024.

  PMID: 39114821 DERIVED

• Crosier R, Kafil TS, Paterson DI. Imaging for Cardiovascular Complications of COVID-19: Cardiac Manifestations in Context. Can J Cardiol. 2023 Jun;39(6):779-792. doi: 10.1016/j.cjca.2023.01.022. Epub 2023 Jan 31.

  PMID: 36731604 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome

Interventions

Magnetic Resonance Imaging; Neuropsychological Tests; Spirometry

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Psychological Tests; Behavioral Disciplines and Activities; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Study Officials

• Ian Paterson, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 25, 2020
• Study Start: November 12, 2020
• Primary Completion: September 22, 2021
• Study Completion: September 30, 2022
• Last Updated: January 26, 2023

Record last verified: 2022-09

Locations

CA (2)