A prospective cohort study evaluating the occurrence of short and long-term cardiovascular complications in patients hospitalized with COVID-19

Recruiting

• Conditions: cardiac abnormalities; cardiac complications; 10082206; 10014523

• Registration Number: NL-OMON52303
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 500

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the incidence of major adverse cardiovascular events (MACE) on the<br /><br>short (6-months) and long-term (1-, 2-, 5- and 10-years) in patients that have<br /><br>been hospitalized for COVID-19. </p><br>