Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04636320
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2020-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Myocardial Scars on CMR After COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'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'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D015716', 'term': 'Electrocardiography, Ambulatory'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-centre case-control study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of myocardial scars', 'timeFrame': 'Day 0', 'description': 'Expressed in percentage of participant, as assessed on late gadolinium-enhanced magnetic resonance acquired at high resolution using a free breathing 3D method.'}], 'secondaryOutcomes': [{'measure': 'CMR feature : Location and size of myocardial scars', 'timeFrame': 'Day 0', 'description': 'Measured in mL'}, {'measure': 'CMR feature : native T1 and T2 values', 'timeFrame': 'Day 0', 'description': 'Measured in milliseconds'}, {'measure': 'CMR feature : extracellular volume fraction', 'timeFrame': 'Day 0', 'description': 'Measured in percentage'}, {'measure': 'CMR feature : ventricular volumes', 'timeFrame': 'Day 0', 'description': 'Measured in mL/m2'}, {'measure': 'CMR feature : ejection fraction', 'timeFrame': 'Day 0', 'description': 'Measured in percentage'}, {'measure': 'CMR feature : myocardial strain', 'timeFrame': 'Day 0', 'description': 'Measured in percentage'}, {'measure': 'ECG features', 'timeFrame': 'Baseline and month 3', 'description': 'Repolarization abnormalities, T wave inversion, ST segment abnormalities, QRS fractionation, atrial arrhythmias, premature ventricular beats or ventricular tachycardia.These will be assessed at the time of CMR study on a resting 12-lead ECG recording and on exercise 12-lead ECG and 24-hour Holter ECG recordings.'}, {'measure': 'Biological feature : positivity of COVID-19 serology', 'timeFrame': 'Baseline and month 3', 'description': 'Rate of seropositivity in asymptomatic volunteers and rate of seronegativity in patients with a history of symptomatic episodes.\n\nMeasured in percentage.'}, {'measure': 'Biological feature : troponin level', 'timeFrame': 'Day 0', 'description': 'Measured in fg/ml'}, {'measure': 'Biological feature : inflammatory markers level', 'timeFrame': 'Day 0', 'description': 'Markers of inflammation and fibrosis will be sought. The Th1/Th2/activation/inflammation/apoptosis markers will be measured in the sera by a Luminex test allowing the detection of 48 analytes.'}, {'measure': 'Genetic profile research', 'timeFrame': 'Day 0', 'description': 'Identified by sequencing genetic variants that could have an impact on the occurrence of a severe form in individuals infected with COVID-19'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial Scar', 'Cardiac Magnetic Resonance', 'Arrhythmia'], 'conditions': ['COVID-19', 'Virus Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the prevalence and arrhythmogenic role of occult myocardial scars on Cardiac Magnetic Resonance (CMR) in a population of patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization, as compared to a population of age- and sex-matched healthy volunteers.', 'detailedDescription': 'Multiple large series conducted in hospitalized patients have reported high rates of myocardial injuries in the acute stage of COVID-19 infection. These findings have raised concerns regarding potential long term consequences of the pandemic on cardiovascular diseases (heart failure and sudden cardiac deaths due to scar-related arrhythmias). However, the prevalence of silent myocardial injuries in the general population who presented a COVID-19 infection managed without hospitalization are unknown. In addition, the propensity of these scars to generate arrhythmias have not been thoroughly studied. COVID CMR will include 120 patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization and 120 age- and sex-matched controls. At day 1, all subjects will undergo a 12-lead electrocardiogram, a contrast-enhanced CMR study including advanced methods to detect silent myocardial scars, and a blood sample to look for markers of inflammation and cardiac injury, and to assess the COVID-19 serological status at the time of the CMR study. The prevalence of myocardial scars on CMR will be compared between the 2 groups. In a second visit at 3 months, patients showing myocardial scar on CMR will be matched to healthy volunteers showing no such scars, and these 2 population subsets will undergo exercise electrocardiogram (ECG) and 24 hour Holter ECG to characterize the arrhythmogenic role of silent myocardial scars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman ≥ 18 years old\n* Affiliated to a health insurance program\n* Providing free, informed, written and signed consent to participate (at the latest on the day of inclusion and before any research procedure is initiated)\n* Effective contraception if women in the age to procreate\n* In the patient group : history of COVID-19 infection with either a positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test on nasopharyngeal swab or a positive COVID-19 serology in the acute stage. Presence of all following symptoms in the acute stage: fever\\>38°C, asthenia, arthromyalgia, associated with at least 2 of the following: coughing and/or spitting, dyspnea and/or chest discomfort, anosmia and/or ageusia.\n\nExclusion Criteria:\n\n* age \\< 18 years old\n* History of cardiac disease or acute coronary syndrome associated with troponin rise\n* History of allergic reaction to gadolinium-based contrast agents\n* History of severe renal failure\n* Presence of a pacemaker, implantable defibrillator, intra-orbital metallic material, intra-cranial surgical clip, valve prosthesis Star-Edwards pre 6000, neurostimulator or implantable insulin pump\n* Claustrophobia or inability to lay on the back for 50 min\n* Pregnant or breast feeding women\n* Inability to express informed consent\n* Person deprived of liberty by judicial or administrative decision\n* Person under legal protection\n* In the healthy volunteer group:\n\n * Symptoms suggestive of COVID-19 infection over the epidemic period (after February 1st 2020)\n * Person not willing to be informed of potential incidental CMR findings\n* In the patient group:\n\n * Hospitalization for infectious syndrome suggestive of COVID-19.'}, 'identificationModule': {'nctId': 'NCT04636320', 'acronym': 'COVID-CMR', 'briefTitle': 'Prevalence of Myocardial Scars on CMR After COVID-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection', 'orgStudyIdInfo': {'id': 'CHUBX 2020/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient group COVID-19', 'description': '120 patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization', 'interventionNames': ['Device: Contrast-enhanced CMR', 'Diagnostic Test: Exercise test ECG', 'Biological: Blood sample', 'Diagnostic Test: Resting 12 lead ECG', 'Diagnostic Test: 24 hour Holter ECG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy volunteer group', 'description': '120 healthy volunteers. Age- and sex-matched controls', 'interventionNames': ['Device: Contrast-enhanced CMR', 'Diagnostic Test: Exercise test ECG', 'Biological: Blood sample', 'Diagnostic Test: Resting 12 lead ECG', 'Diagnostic Test: 24 hour Holter ECG']}], 'interventions': [{'name': 'Contrast-enhanced CMR', 'type': 'DEVICE', 'description': 'Cardiac Magnetic Resonance Imaging (MRI) examinations will be performed at Day 0 visit on clinical systems 1.5 equipped with specific antennas for cardiac imaging. The imaging protocol will last approximately 50 minutes.', 'armGroupLabels': ['Healthy volunteer group', 'Patient group COVID-19']}, {'name': 'Exercise test ECG', 'type': 'DIAGNOSTIC_TEST', 'description': 'A treadmill exercise test with 12 lead ECG monitoring will be performed at M3 visit.\n\nMaximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls.', 'armGroupLabels': ['Healthy volunteer group', 'Patient group COVID-19']}, {'name': 'Blood sample', 'type': 'BIOLOGICAL', 'description': 'A blood sample will be taken at Day 0 visit for COVID-19 serology, hematocrit measurement, ultra-high sensitive troponin test, low grade markers of inflammation, genetic profiling.\n\nAn other blood sample will be taken at M3 visit for a control COVID-19 serology for 30 healthy volunteers.', 'armGroupLabels': ['Healthy volunteer group', 'Patient group COVID-19']}, {'name': 'Resting 12 lead ECG', 'type': 'DIAGNOSTIC_TEST', 'description': 'A resting 12 lead ECG will be performed at Day 0 visit.', 'armGroupLabels': ['Healthy volunteer group', 'Patient group COVID-19']}, {'name': '24 hour Holter ECG', 'type': 'DIAGNOSTIC_TEST', 'description': 'A 24 hour Holter ECG will be performed at M3 visit. Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls.', 'armGroupLabels': ['Healthy volunteer group', 'Patient group COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'overallOfficials': [{'name': 'Hubert COCHET, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grant Agreement ERC n°715093', 'class': 'UNKNOWN'}, {'name': 'University of Bordeaux', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}