To determine the occurrence and natural history of (subclinical) cardiac abnormalities during hospital admission for COVID-19 and the possible cardiovascular complications short-tem (6 months) and long-term (1,2,5,10 years) post-admission.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the incidence of major adverse cardiovascular events (MACE) on the
short (6-months) and long-term (1-, 2-, 5- and 10-years) in patients that have
been hospitalized for COVID-19.
Secondary outcome
• The incidence of all-cause mortality on the short (6-months) and long-term
(1-, 2-, 5- and 10-years).
• To establish the incidence of systolic and diastolic ventricular dysfunction
on echocardiography during hospital admission for COVID-19 and 6-months after
admission in patients with and without a clinical indication to receive
cardiological care during hospital admission according to the NVVC guideline.
• To determine if echocardiographic abnormalities detected during
hospitalization persist or are reversible 6-months post admission.
• To evaluate the efficiency of the healthcare pathway to identify patients
with persisting cardiac abnormalities and MACE during follow-up.
• To determine the prognostic value of myocardial injury and echocardiographic
abnormalities during hospitalization to predict MACE on the short (6-months)
and long-term (1-, 2-, 5- and 10-years).
• To determine how the incidence of MACE in patients hospitalized for COVID-19
relates to the incidence of MACE after hospitalization for seasonal influenza
and other common respiratory tract infections.
• To evaluate whether the incidence of (subclinical) cardiovascular
complications is related to COVID-19 disease severity.
• To evaluate patients reported outcome measures (PROM*s) up to five years
after hospitalization for COVID-19.
• To establish whether PROM*s collected during follow-up predict the occurrence
of systolic- and diastolic dysfunction on echocardiography and MACE.
• To determine the impact of myocardial injury and echocardiographic
abnormalities during hospitalization on PROM*s on the short (6-months) and
long-term (1-, 2-, 5-and 10-year).
• To evaluate the added value of troponin levels and various inflammatory
markers measured <24h of admission for the prediction of in-hospital mortality.
• To evaluate the incidence of (subclinical) cardiac arrhythmias using a
wearable single lead ECG.
• To evaluate whether findings obtained with the wearable biosensor predict the
occurrence of MACE.
• To determine the prevalence, reversibility and prognostic significance of
cardiac abnormalities on Cardiac Magnetic Resonance (CMR) scan after SARS-CoV-2
infection
Background summary
Concerns of cardiovascular complications after a SARS-CoV-2 infection have been
raised after a number of case reports and imaging studies performed after a
COVID-19 infection. This has fueled media headlines and leads to distress among
the public and patients with pre-existing cardiovascular disease. This study
wants to perform a prospective study to overcome limitations of existing
studies to be able to ascertain a causal relationship between SARS-CoV-2
infection and observed (cardiovascular) findings with a long-term follow-up to
assess the occurrence and natural history of cardiac abnormalities.
Study objective
To determine the occurrence and natural history of (subclinical) cardiac
abnormalities during hospital admission for COVID-19 and the possible
cardiovascular complications short-tem (6 months) and long-term (1,2,5,10
years) post-admission.
Study design
This study is designed as a national prospective cohort study and will be
conducted in ~20 larger peripheral and academic hospitals in the Netherlands
with an inclusion of ~25 patients per site. A total of 500 patients will be
included and receive follow-up.
Study burden and risks
According to the recommended standardized health care pathway that will be
implemented, most procedures (medical history, physical examination,
hematology, blood chemistry, cardiac biomarkers, ECG, cardiac MRI) will be part
of the regular recommended care. Echocardiography (2x), physical examination
(1x) and the ECG at 6 month follow-up for the control group and questionnaires
for both groups are study examinations.
If a patient participates in the CMR substudy, a CMR scan will be performed 6
months after the initial admission to the hospital with COVID-19 and will be
repeated after 9 months and possibly 12 months, depending on the findings of
the first CMR scan.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
• Age >=18 and <70 years
• A PCR confirmed infection with SARS-CoV-2 <48h of admission
• Treatment of COVID-19 is the primary reason of hospitalization
• The patient was independent in ADL prior to admission
• The patient or proxy (close relative) is capable of giving informed consent
To be included in the healthcare pathway group, at least two of the following
additional criteria should be met within 48h of admission:
• Troponin levels >4x ULN
• New ECG abnormalities including repolarization abnormalities, arrhythmia,
signs of right ventricular strain, axis deviation, dynamic ECG changes or any
other new abnormalities on ECG deemed clinically relevant by a cardiologist.
NOTE: This criterion is not met in case of any (likely) pre-existent
electrocardiographic abnormalities.
• Suspicion of cardiac disease
To be included in the control group, at least two of the following criteria
should be met within 48h of admission:
•Troponin levels <4x ULN
•No new ECG abnormalities including repolarization abnormalities, arrhythmia,
signs of right ventricular strain, axis deviation, dynamic ECG changes or any
other abnormalities deemed clinically relevant by a cardiologist).
•No suspicion of cardiac disease
Exclusion criteria
Anticipated) in-hospital stay <48h
• First admission for COVID-19 took place in another hospital and the patient
was transferred to the current hospital >48h after first admission
• Recent (<6 months) cardiac pathology prior to hospital admission including:
o Myocardial infarction or unstable angina
o Decompensated heart failure that required hospital admission
o Uncontrolled ventricular arrhythmia
o Percutaneous coronary intervention, CABG, valvular replacement or any other
major cardiac surgery
o Cardiac device implantation
o NOTE: Cardiac pathology secondary to a SARS-CoV-2 infection is not a reason
for exclusion.
• Anatomical deviations (incl. breast implants) anticipated to significantly
hamper the echocardiographic imaging quality
• Clinical signs of severe cerebral dysfunction
• Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol
• (Planned) pregnancy
Design
Recruitment
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 | NL76035.041.21 |