COVID-19COVID-CMRNCT04636320
Prevalence of Myocardial Scars on CMR After COVID-19 Infection
A study testing Contrast-enhanced CMR, Exercise test ECG and Blood sample in people with COVID-19 and Virus Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Virus Disease
- What is being tested?
- Contrast-enhanced CMR, Exercise test ECG and Blood sample
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2020to 4 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman ≥ 18 years old
- Affiliated to a health insurance program
- Providing free, informed, written and signed consent to participate (at the latest on the day of inclusion and before any research procedure is initiated)
- Effective contraception if women in the age to procreate
- 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.
Who cannot join
- age < 18 years old
- History of cardiac disease or acute coronary syndrome associated with troponin rise
- History of allergic reaction to gadolinium-based contrast agents
- History of severe renal failure
- 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
- Claustrophobia or inability to lay on the back for 50 min
Show all 15Show fewer
- Pregnant or breast feeding women
- Inability to express informed consent
- Person deprived of liberty by judicial or administrative decision
- Person under legal protection
- In the healthy volunteer group:
- Symptoms suggestive of COVID-19 infection over the epidemic period (after February 1st 2020)
- Person not willing to be informed of potential incidental CMR findings
- In the patient group:
- Hospitalization for infectious syndrome suggestive of COVID-19.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
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.
Read the detailed description
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.
- Conditions
- COVID-19, Virus Disease
- Being tested
- Contrast-enhanced CMR, Exercise test ECG, Blood sample, Resting 12 lead ECG, 24 hour Holter ECG
- Keywords
- Myocardial Scar, Cardiac Magnetic Resonance, Arrhythmia
- Medical subject headings
- COVID-19, Virus Diseases, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced CMRDevice
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.
Exercise test ECGDiagnostic test
A treadmill exercise test with 12 lead ECG monitoring will be performed at M3 visit.
Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls.
Blood sampleBiological
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.
An other blood sample will be taken at M3 visit for a control COVID-19 serology for 30 healthy volunteers.
Resting 12 lead ECGDiagnostic test
A resting 12 lead ECG will be performed at Day 0 visit.
24 hour Holter ECGDiagnostic test
A 24 hour Holter ECG will be performed at M3 visit. Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls.
| Study group | Role | What they receive |
|---|---|---|
| Patient group COVID-19 | Experimental | 120 patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization Receives: Device: Contrast-enhanced CMR; Diagnostic Test: Exercise test ECG; Biological: Blood sample; Diagnostic Test: Resting 12 lead ECG; Diagnostic Test: 24 hour Holter ECG |
| Healthy volunteer group | Active comparator | 120 healthy volunteers. Age- and sex-matched controls Receives: Device: Contrast-enhanced CMR; Diagnostic Test: Exercise test ECG; Biological: Blood sample; Diagnostic Test: Resting 12 lead ECG; Diagnostic Test: 24 hour Holter ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of myocardial scars
Expressed in percentage of participant, as assessed on late gadolinium-enhanced magnetic resonance acquired at high resolution using a free breathing 3D method.
Measured: Day 0
Secondary outcomes (11)
CMR feature : Location and size of myocardial scars
Measured in mL
Measured: Day 0
CMR feature : native T1 and T2 values
Measured in milliseconds
Measured: Day 0
CMR feature : extracellular volume fraction
Measured in percentage
Measured: Day 0
CMR feature : ventricular volumes
Measured in mL/m2
Measured: Day 0
CMR feature : ejection fraction
Measured in percentage
Measured: Day 0
CMR feature : myocardial strain
Measured in percentage
Measured: Day 0
ECG features
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.
Measured: Baseline and month 3
Biological feature : positivity of COVID-19 serology
Rate of seropositivity in asymptomatic volunteers and rate of seronegativity in patients with a history of symptomatic episodes.
Measured in percentage.
Measured: Baseline and month 3
Biological feature : troponin level
Measured in fg/ml
Measured: Day 0
Biological feature : inflammatory markers level
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.
Measured: Day 0
Genetic profile research
Identified by sequencing genetic variants that could have an impact on the occurrence of a severe form in individuals infected with COVID-19
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start13 Jun 2020
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre case-control study
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Grant Agreement ERC n°715093, University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- Hubert COCHET, MD-PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636320
- Sponsor's protocol ID
- CHUBX 2020/22
- Acronym
- COVID-CMR
- Status last verified
- Mar 2023
- First submitted
- 18 Nov 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Silent Myocardial Scars on Cardiac Magnetic Resonance Following COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04636320
- Acronym / sponsor ID
- COVID-CMR / CHUBX 2020/22
- Conditions
- COVID-19, Virus Disease
- Keywords
- Myocardial Scar, Cardiac Magnetic Resonance, Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Grant Agreement ERC n°715093, University of Bordeaux
- Study start
- 13 Jun 2020 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-centre case-control study
| Arm | Type | Receives |
|---|---|---|
| Patient group COVID-19 | Experimental | Device: Contrast-enhanced CMR, Diagnostic Test: Exercise test ECG, Biological: Blood sample, Diagnostic Test: Resting 12 lead ECG, Diagnostic Test: 24 hour Holter ECG120 patients with history of laboratory-proven symptomatic COVID-19 infection managed without hospitalization |
| Healthy volunteer group | Active comparator | Device: Contrast-enhanced CMR, Diagnostic Test: Exercise test ECG, Biological: Blood sample, Diagnostic Test: Resting 12 lead ECG, Diagnostic Test: 24 hour Holter ECG120 healthy volunteers. Age- and sex-matched controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Man or woman ≥ 18 years old
- Affiliated to a health insurance program
- Providing free, informed, written and signed consent to participate (at the latest on the day of inclusion and before any research procedure is initiated)
- Effective contraception if women in the age to procreate
- 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.
Key exclusion criteria (15 listed)
- age < 18 years old
- History of cardiac disease or acute coronary syndrome associated with troponin rise
- History of allergic reaction to gadolinium-based contrast agents
- History of severe renal failure
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced CMRCardiac 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. | Device | Healthy volunteer group, Patient group COVID-19 |
| Exercise test ECGA treadmill exercise test with 12 lead ECG monitoring will be performed at M3 visit. Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls. | Diagnostic test | Healthy volunteer group, Patient group COVID-19 |
| Blood sampleA 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. An other blood sample will be taken at M3 visit for a control COVID-19 serology for 30 healthy volunteers. | Biological | Healthy volunteer group, Patient group COVID-19 |
| Resting 12 lead ECGA resting 12 lead ECG will be performed at Day 0 visit. | Diagnostic test | Healthy volunteer group, Patient group COVID-19 |
| 24 hour Holter ECGA 24 hour Holter ECG will be performed at M3 visit. Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls. | Diagnostic test | Healthy volunteer group, Patient group COVID-19 |
Primary outcome
Prevalence of myocardial scars
Time frame: Day 0
Expressed in percentage of participant, as assessed on late gadolinium-enhanced magnetic resonance acquired at high resolution using a free breathing 3D method.
11 secondary outcomes
CMR feature : Location and size of myocardial scars
Time frame: Day 0
CMR feature : native T1 and T2 values
Time frame: Day 0
CMR feature : extracellular volume fraction
Time frame: Day 0
CMR feature : ventricular volumes
Time frame: Day 0
CMR feature : ejection fraction
Time frame: Day 0
CMR feature : myocardial strain
Time frame: Day 0
ECG features
Time frame: Baseline and month 3
Biological feature : positivity of COVID-19 serology
Time frame: Baseline and month 3
Biological feature : troponin level
Time frame: Day 0
Biological feature : inflammatory markers level
Time frame: Day 0
Genetic profile research
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert COCHET, MD-PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced CMR, Exercise test ECG and Blood sample in people with COVID-19 and Virus Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of myocardial scars (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.