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

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ClinicalTrials.gov Identifier: NCT04325412

Recruitment Status : Recruiting

First Posted : March 27, 2020

Last Update Posted : November 10, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Prof. Dr. F.W. Asselbergs, UMC Utrecht

Tracking Information

First Submitted Date

March 25, 2020

First Posted Date

March 27, 2020

Last Update Posted Date

November 10, 2020

Actual Study Start Date

March 23, 2020

Estimated Primary Completion Date

March 23, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

The incidence of cardiovascular complications in patients with COVID-19 [ Time Frame: 30 days ]

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

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

Official Title

Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY

Brief 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.

Detailed 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

Study Type

Observational [Patient Registry]

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

30 Days

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

All patients were admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2.

Condition

COVID-19; Cardiovascular Diseases

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

1000

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

June 23, 2021

Estimated Primary Completion Date

March 23, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Highly suspected/confirmed infection with SARS-CoV-2

Exclusion Criteria:

- Patients that opt-out

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact: Folkert W. Asselbergs, MD, PhD

+31 (0) 88 755 5555

f.w.asselbergs@umcutrecht.nl

Listed Location Countries

Netherlands

Removed Location Countries

Administrative Information

NCT Number

NCT04325412

Other Study ID Numbers

20-161/C

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Prof. Dr. F.W. Asselbergs, UMC Utrecht

Study Sponsor

UMC Utrecht

Collaborators

Not Provided

Investigators

Not Provided

PRS Account

UMC Utrecht

Verification Date

November 2020

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