MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients
NCT ID: NCT04525404
Last Updated: 2023-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
215 participants
OBSERVATIONAL
2020-11-12
2022-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
MRI (heart, brain, lungs, liver)
MRI (heart, brain, lungs, liver)
Bloodwork
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
Cognitive testing
NIH toolbox Cognitive Measures
Olfaction testing
Brief Smell Identification Test (BSIT)
Spirometry
Spirometry to evaluate forced expiratory volume in 1 second and forced vital capacity
Walk Test
Walk test to record overall distance walked in 6 minutes and time taken to walk the first 25 feet
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.
MRI (heart, brain, lungs, liver)
MRI (heart, brain, lungs, liver)
Bloodwork
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
Cognitive testing
NIH toolbox Cognitive Measures
Olfaction testing
Brief Smell Identification Test (BSIT)
Spirometry
Spirometry to evaluate forced expiratory volume in 1 second and forced vital capacity
Walk Test
Walk test to record overall distance walked in 6 minutes and time taken to walk the first 25 feet
Interventions
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MRI (heart, brain, lungs, liver)
MRI (heart, brain, lungs, liver)
Bloodwork
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
Cognitive testing
NIH toolbox Cognitive Measures
Olfaction testing
Brief Smell Identification Test (BSIT)
Spirometry
Spirometry to evaluate forced expiratory volume in 1 second and forced vital capacity
Walk Test
Walk test to record overall distance walked in 6 minutes and time taken to walk the first 25 feet
Eligibility Criteria
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Inclusion Criteria
2. Willing and able to provide informed consent
3. COVID-19 positive test (within 14 days of positive test date)
4. High-sensitivity Troponin-I \>100ng/L or Troponin T \> 52ng/L
5. Ability to obtain Baseline MRI imaging within 7 days (up to 14 days maximum) of Troponin result
1. 18 years of age or older
2. Willing and able to provide informed consent
3. Previously diagnosed with COVID-19 \> 3 months ago
4. Ability to obtain MRI imaging at minimum 12 weeks from COVID-19 diagnosis
Exclusion Criteria
2. GFR \< 30ml/kg/min/1.73m2
3. Hemodynamic instability requiring inotropic agents
4. Active ventilatory support
1\. Contraindication to MRI or MRI contrast
18 Years
ALL
No
Sponsors
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Canadian VIGOUR Centre
OTHER
University of Alberta
OTHER
Responsible Party
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Principal Investigators
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Ian Paterson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Countries
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References
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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.
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.
Other Identifiers
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Pro00102389
Identifier Type: -
Identifier Source: org_study_id
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