Primary and Secondary: To assess cardiovascular function and the presence and magnitude of myocardial injury using echocardiography and cardiac magnetic resonance (CMR) imaging, among community-dwelling individuals who recovered from Covid-19…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cardiac MRI parameters
Secondary outcome
Parameters for cardiac structure en function.
Also:
- Blood makers, including lipids (total cholesterol, HDL-cholesterol and
triglycerides), glucose, CRP, Creatinine, Troponin I or T, NT-proBNP)
- Data collected from questionnaires, e.g. covid-related symptoms and fatigue
- Cardiovascular risk factors
Other study parameters:
Sleep and activity:
- Sleep (Total sleep time, Sleep onset latency, Wake after sleep onset, Sleep
efficiency)
- 24-hour activity rhythms (Interdaily stability, Intradaily variability, Onset
lowest hours of activity)
- Mental health
Background summary
Early evidence suggests that Covid-19 infection may have substantial
implications on both short and long-term cardiovascular health. Beyond its
acute impact, Covid-19 infection might carry the potential for persistent
myocardial damage and therefore long-term cardiovascular complications.
Although initial reports suggest that Covid-19 is associated with relatively
high rates of acute cardiovascular complications, the late effects of
SARS-CoV-2 on the cardiovascular system remain largely unknown. Moreover, the
majority of evidence is based on most severe hospitalized and ICU-cases of
Covid-19 infections and knowledge regarding the less severe (self-limiting)
forms of infection (i.e. Covid@home) remains scarce.
Population-based cohort studies with detailed cardiovascular phenotyping data
collected before the Covid-19 pandemic are uniquely-positioned to provide data
on community-based Covid-19, to distinguish the role of Covid-19 infection in
precipitating progression of pre-existing, asymptomatic cardiovascular
dysfunction (i.e. Covid-19 as a stress test for cardiovascular system), and to
assure a unique set for gathering reliable longitudinal follow-up data on
Covid-19 at community level.*
Study objective
Primary and Secondary: To assess cardiovascular function and the presence and
magnitude of myocardial injury using echocardiography and cardiac magnetic
resonance (CMR) imaging, among community-dwelling individuals who recovered
from Covid-19 infection at home (thus not hospitalized; i.e. Covid@home). The
cardiovascular function will further be examined in association with the
severity of Covid-19 infection based on the symptoms gathered through detailed
questionnaires at the time of infection. We will further examine changes in
cardiovascular function using the newly (post-Covid) gathered data and the
already available echocardiography assessments from the previous visits of the
Rotterdam Study. *
Other objectives: To assess sleep, fatigue and mental health among individuals
who recovered from Covid-19 infection at home and to relate these factors (in
particular fatigue) with primary outcomes of cardiovascular function and
injury.
Study design
This project - a (nested) cohort study - will include participants of the
Rotterdam Study who recovered from a Covid-19 infection at home (thus not
hospitalized; i.e. Covid@home). The Rotterdam Study (ERGO) is a prospective,
population-based cohort study, comprising 17,931 persons aged 40 years and
over, residing in the Ommoord district of Rotterdam, who are (re-)examined
every three to four years. The Rotterdam Study has sent extensive Covid-19
questionnaires to the participants from the beginning of pandemic. 100
Covid@home persons from the Rotterdam Study will be invited for two additional
visits. The first visit will be at the Rotterdam Study Research Center, where
several measurements will be performed, including blood collection for lab
measurements (including cardiovascular risk factors, cardiac biomarkers
Troponin I or T and proBNP, and other serum markers of general health), ECG,
echocardiography, pulse wave velocity, heart rate variability and blood
pressure. Moreover, ECG sensor, an actigraphy and several questionnaires
(including questionnaires for sleep, fatigue, depressive symptoms and anxiety)
will be handed out to the participants. *The second visit will be for a CMR
examination at Erasmus MC. Depending on the CMR capacity at Erasmus MC, a group
of the participants will be sent to Radboud UMC for CMR (in collaboration with
Alexander Hirsch).*
Study burden and risks
This study has a scientific purpose. Participants do not benefit directly or
personally from participation in this study. With respect to other exams
carried out within the Rotterdam Study, the policy is followed that a
participant*s treating physician can request the (results of) exams any time,
if these are deemed relevant in a clinical setting. The same policy will be
followed for the current study. *There is a chance that we will detect
incidental or abnormal findings and these will be reported to the participants
and their general physician using a standardized protocol (when given informed
consent). *
CMR examination: The CMR scans will be checked for incidental findings
following the protocol for incidental findings on CMR. This assessment takes
place by trained physician and per protocol devised by an expert Cardiology and
Imaging panel. The risks associated with this study are extremely low. MRI has
no associated health risks. MRI does not require ionizing radiation. The MRI
protocol does include the administration of a gadolinium contrast bolus, but
gadolinium contrast is well tolerated with only very rare cases of gadolinium
allergy reported in the literature. Reported specific side effects include
nausea (0.25%), vomiting (0.05%), urticaria (0.04%), feeling of warmth,
tachycardia, wheals (for each 0.03%), dizziness, itching, vasodilatation, itchy
throat (for each 0.02%) and cough, dyspnea, flushing, hives, generalized
itching, oral dryness, facial redness, sensation of heat, skin disorder and
aggravated nausea (for each, 0.01%).
To exclude the risk of contrast-induced nephrogenic systemic fibrosis,
individuals with glomerular filtration rate < 30 ml/min will not be included.
When patients wish to stop the scanning procedure and get out of the scanner
they can press an *alert button*, which is standard procedure for every MRI.
Patients are also able to talk to the researchers in the control room at any
time during the experiment.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Participants of the Rotterdam Study who recovered from a Covid-19 infection at
home.
Exclusion criteria
Participants with prior known myocardial infarction (based on the information
previously collected within the Rotterdam Study from the GP registries) and/or
eGFR < 30 ml/min (based on the results acquired in previous rounds of the
Rotterdam Study), will be excluded from this study.
Subjects who meets any of the following criteria will be excluded from
undergoing the CMR: *
- Known contra-indications for CMR (e.g.: severe claustrophobia, metal
implants, severe renal failure)
- (e)GFR < 30 ml/min
- Known allergy for contrast
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL77846.078.21 |