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

November 6, 2020 updated by: Prof. Dr. F.W. Asselbergs, UMC Utrecht

Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Patients that opt-out

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2020

Primary Completion (ANTICIPATED)

March 23, 2021

Study Completion (ANTICIPATED)

June 23, 2021

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (ACTUAL)

March 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-161/C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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