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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
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. F.W. Asselbergs, UMC Utrecht

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
COVID-19; Cardiovascular Diseases

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY
Actual Study Start Date : March 23, 2020
Estimated Primary Completion Date : March 23, 2021
Estimated Study Completion Date : June 23, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The incidence of cardiovascular complications in patients with COVID-19 [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Patients that opt-out


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325412


Contacts
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Contact: Folkert W. Asselbergs, MD, PhD +31 (0) 88 755 5555 f.w.asselbergs@umcutrecht.nl

Locations
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Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Marijke Linschoten, MD    +31 (0)88 755 5555    m.p.m.linschoten@umcutrecht.nl   
Sponsors and Collaborators
UMC Utrecht
Additional Information:
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Responsible Party: Prof. Dr. F.W. Asselbergs, UMC Utrecht
ClinicalTrials.gov Identifier: NCT04325412    
Other Study ID Numbers: 20-161/C
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Cardiovascular Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases