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

A prospective cohort study evaluating the occurrence of short and long-term cardiovascular complications in patients hospitalized with COVID-19 - CAPACITY 2

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52303

Enrollment

500

Registered

2021-03-29

Start date

2021-06-02

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac abnormalities cardiac complications

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >=18 and 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

Exclusion criteria

Exclusion criteria: Anticipated) in-hospital stay 48h after first admission • Recent (

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
• 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 (PROMs) up to five years after hospitalization for COVID-19. • To establish whether PROMs 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	—

Measure

Time frame

• 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

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Countries

Netherlands

Outcome results