Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT04525404
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2020-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D013147', 'term': 'Spirometry'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-21', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Native myocardial T1 relaxation time', 'timeFrame': '12 weeks post COVID-19 diagnosis', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'FLAIR imaging', 'timeFrame': '12 weeks post COVID-19 diagnosis', 'description': 'Similar within group and between group comparisons of MRI derived lung water content, liver water content, and the presence of brain inflammation on FLAIR imaging'}, {'measure': 'Compare 12-week cognitive testing to the corresponding findings on MRI of brain, heart and lung at baseline', 'timeFrame': '12 weeks post COVID-19 diagnosis', 'description': 'Compare 12-week cognitive testing (NIH toolbox score) to the corresponding findings on MRI of brain, heart and lung at baseline'}, {'measure': 'Compare 12-week spirometry to the corresponding findings on MRI of brain, heart and lung at baseline', 'timeFrame': '12 weeks post COVID-19 diagnosis', 'description': 'Compare 12-week spirometry (FEV1, FVC and FEV1:FVC) to the corresponding findings on MRI of brain, heart and lung at baseline'}, {'measure': 'Compare 12-week walk test results to the corresponding findings on MRI of brain, heart and lung at baseline', 'timeFrame': '12 weeks post COVID-19 diagnosis', 'description': 'Compare 12-week walk test results (distance and time) to the corresponding findings on MRI of brain, heart and lung at baseline'}, {'measure': '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', 'timeFrame': '12 weeks post COVID-19 diagnosis', 'description': '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'}, {'measure': 'Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic', 'timeFrame': '12-24 weeks post COVID-19 diagnosis', 'description': 'Compare MRI measures of organ dysfunction at 12-24 weeks in survivors according to severity of prior COVID-19 illness: (i) hospitalized, (ii) symptomatic, not hospitalized and (iii) asymptomatic'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Coronavirus Infection', 'SARS-CoV Infection']}, 'referencesModule': {'references': [{'pmid': '39114821', 'type': 'DERIVED', 'citation': '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': '36731604', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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).\n\nThe study investigators hope this study will help us learn more about the long-term risks of COVID-19 disease.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants with new or recent COVID-19 infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Troponin substudy Inclusion Criteria:\n\n1. 18 years of age or older\n2. Willing and able to provide informed consent\n3. COVID-19 positive test (within 14 days of positive test date)\n4. High-sensitivity Troponin-I \\>100ng/L or Troponin T \\> 52ng/L\n5. Ability to obtain Baseline MRI imaging within 7 days (up to 14 days maximum) of Troponin result\n\nTroponin substudy Exclusion Criteria:\n\n1. Contraindication to MRI or MRI contrast\n2. GFR \\< 30ml/kg/min/1.73m2\n3. Hemodynamic instability requiring inotropic agents\n4. Active ventilatory support\n\nLate cross-sectional substudy Inclusion Criteria:\n\n1. 18 years of age or older\n2. Willing and able to provide informed consent\n3. Previously diagnosed with COVID-19 \\> 3 months ago\n4. Ability to obtain MRI imaging at minimum 12 weeks from COVID-19 diagnosis\n\nLate cross-sectional substudy Exclusion Criteria:\n\n1\\. Contraindication to MRI or MRI contrast'}, 'identificationModule': {'nctId': 'NCT04525404', 'acronym': 'MOIST', 'briefTitle': 'MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'MOIST Study: Multi-Organ Imaging With Serial Testing in COVID-19 Infected Patients', 'orgStudyIdInfo': {'id': 'Pro00102389'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Troponin Substudy', 'description': '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.', 'interventionNames': ['Diagnostic Test: MRI (heart, brain, lungs, liver)', 'Diagnostic Test: Bloodwork', 'Other: Cognitive testing', 'Other: Olfaction testing', 'Diagnostic Test: Spirometry', 'Other: Walk Test']}, {'label': 'Late Cross-Sectional Substudy', 'description': '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.', 'interventionNames': ['Diagnostic Test: MRI (heart, brain, lungs, liver)', 'Diagnostic Test: Bloodwork', 'Other: Cognitive testing', 'Other: Olfaction testing', 'Diagnostic Test: Spirometry', 'Other: Walk Test']}], 'interventions': [{'name': 'MRI (heart, brain, lungs, liver)', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI (heart, brain, lungs, liver)', 'armGroupLabels': ['Late Cross-Sectional Substudy', 'Troponin Substudy']}, {'name': 'Bloodwork', 'type': 'DIAGNOSTIC_TEST', 'description': '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', 'armGroupLabels': ['Late Cross-Sectional Substudy', 'Troponin Substudy']}, {'name': 'Cognitive testing', 'type': 'OTHER', 'description': 'NIH toolbox Cognitive Measures', 'armGroupLabels': ['Late Cross-Sectional Substudy', 'Troponin Substudy']}, {'name': 'Olfaction testing', 'type': 'OTHER', 'description': 'Brief Smell Identification Test (BSIT)', 'armGroupLabels': ['Late Cross-Sectional Substudy', 'Troponin Substudy']}, {'name': 'Spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Spirometry to evaluate forced expiratory volume in 1 second and forced vital capacity', 'armGroupLabels': ['Late Cross-Sectional Substudy', 'Troponin Substudy']}, {'name': 'Walk Test', 'type': 'OTHER', 'description': 'Walk test to record overall distance walked in 6 minutes and time taken to walk the first 25 feet', 'armGroupLabels': ['Late Cross-Sectional Substudy', 'Troponin Substudy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Ian Paterson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian VIGOUR Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}