Cardiac complicAtions in Patients With SARS Corona vIrus 2 (COVID-19) regisTrY

COVID-19; Cardiovascular Diseases Clinical Trial

— CAPACITY-COVID  

Official title:

Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04325412
• Other study ID #: 20-161/C
• Status: Recruiting
• Start date: March 23, 2020
• Est. completion date: June 23, 2021

Study information

• Verified date: November 2020
• Source: UMC Utrecht
• Contact: Folkert W. Asselbergs, MD, PhD
• Phone: +31 (0) 88 755 5555
• Email: f.w.asselbergs[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

CAPACITY (www.capacity-covid.eu) is a registry of patients with COVID-19 across Europe and has been established to answer questions on the role of cardiovascular disease in this pandemic. It is an extension of the Case Record Form (CRF) that was released by the ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) and WHO (World Health Organisation) in response to the emerging outbreak of COVID-19.

Description:

The aim of CAPACITY is to collect data regarding the cardiovascular history, diagnostic information and occurrence of cardiovascular complications in COVID-19 patients. By collecting this information in a standardized manner, CAPACITY can aid in providing more insight in (1) the incidence of cardiovascular complications in patients with COVID-19, and (2) the vulnerability and clinical course of COVID-19 in patients with an underlying cardiovascular disease.

The CAPACITY extension to the ISARIC-WHO CRF consists of additional data collection instruments for:

• cardiac history and cardiovascular risk factors

• prior use of cardiac medication or NSAIDs

• electrocardiography (ECG)

• echocardiography

• cardiac MRI

• invasive cardiac procedures

• cardiac complications

• cardiac biomarkers

• cardiac outcome during admission

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 23, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Highly suspected/confirmed infection with SARS-CoV-2

Exclusion Criteria:

• Patients that opt-out

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronavirus Infections
• COVID-19; Cardiovascular Diseases

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of cardiovascular complications in patients with COVID-19		30 days

External Links

•   All study documents can be found on this website.