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

Sponsor
UMC Utrecht (Other)
Overall Status
Recruiting
CT.gov ID
NCT04325412
Collaborator
(none)
1,000
Enrollment
1
Location
15
Anticipated Duration (Months)
66.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY
    Actual Study Start Date :
    Mar 23, 2020
    Anticipated Primary Completion Date :
    Mar 23, 2021
    Anticipated Study Completion Date :
    Jun 23, 2021

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of cardiovascular complications in patients with COVID-19 [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Highly suspected/confirmed infection with SARS-CoV-2
    Exclusion Criteria:
    • Patients that opt-out

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Utrecht Utrecht Netherlands 3584 CX

    Sponsors and Collaborators

    • UMC Utrecht

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Prof. Dr. F.W. Asselbergs, Prof. Dr. F.W. Asselbergs, UMC Utrecht
    ClinicalTrials.gov Identifier:
    NCT04325412
    Other Study ID Numbers:
    • 20-161/C
    First Posted:
    Mar 27, 2020
    Last Update Posted:
    Nov 10, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Coronavirus Infections
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Nov 10, 2020