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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

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
 (submitted: March 25, 2020)
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
 (submitted: March 25, 2020)
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 No
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