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

NCT ID: NCT04525404

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-12

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants with newly or recently diagnosed COVID-19 infection (inpatients and outpatients) will undergo multi-organ MRI (heart, brain, lungs, liver), blood work, and functional testing at one or more time points. Functional testing will include olfaction testing, cognitive testing, spiromety, and a walk test.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 Coronavirus Infection SARS-CoV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Intervention Type DIAGNOSTIC_TEST

MRI (heart, brain, lungs, liver)

Bloodwork

Intervention Type 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

Cognitive testing

Intervention Type OTHER

NIH toolbox Cognitive Measures

Olfaction testing

Intervention Type OTHER

Brief Smell Identification Test (BSIT)

Spirometry

Intervention Type DIAGNOSTIC_TEST

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

Walk Test

Intervention Type OTHER

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)

Intervention Type DIAGNOSTIC_TEST

MRI (heart, brain, lungs, liver)

Bloodwork

Intervention Type 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

Cognitive testing

Intervention Type OTHER

NIH toolbox Cognitive Measures

Olfaction testing

Intervention Type OTHER

Brief Smell Identification Test (BSIT)

Spirometry

Intervention Type DIAGNOSTIC_TEST

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

Walk Test

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI (heart, brain, lungs, liver)

MRI (heart, brain, lungs, liver)

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Cognitive testing

NIH toolbox Cognitive Measures

Intervention Type OTHER

Olfaction testing

Brief Smell Identification Test (BSIT)

Intervention Type OTHER

Spirometry

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

Intervention Type DIAGNOSTIC_TEST

Walk Test

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 18 years of age or older
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

1. Contraindication to MRI or MRI contrast
2. GFR \< 30ml/kg/min/1.73m2
3. Hemodynamic instability requiring inotropic agents
4. Active ventilatory support


1\. Contraindication to MRI or MRI contrast
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canadian VIGOUR Centre

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ian Paterson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Calgary

Calgary, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39114821 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36731604 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00102389

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Accelerated Stress CMR in Coronary Artery Disease
NCT05221762 ACTIVE_NOT_RECRUITING