Cardiac complicAtions in Patients With SARS Corona vIrus... | NCT04325412

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

NCT04325412

Sponsor

UMC Utrecht

Status

Unknown status

Last Update Posted

Nov 10, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

COVID-19; Cardiovascular Diseases

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2020Actual

Primary Completion Date

Mar 23, 2021Estimated

Completion Date

Jun 23, 2021Estimated

First Submitted Date

Mar 25, 2020

First Submission Date that Met QC Criteria

Mar 25, 2020

First Posted Date

Mar 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2020

Last Update Posted Date

Nov 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Highly suspected/confirmed infection with SARS-CoV-2

Exclusion Criteria:

- Patients that opt-out

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Folkert W. Asselbergs, MD, PhD	Contact	+31 (0) 88 755 5555		f.w.asselbergs@umcutrecht.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Utrecht	Recruiting	Utrecht		3584 CX	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35247983	Derived	Henkens MTHM, Raafs AG, Verdonschot JAJ, Linschoten M, van Smeden M, Wang P, van der Hooft BHM, Tieleman R, Janssen MLF, Ter Bekke RMA, Hazebroek MR, van der Horst ICC, Asselbergs FW, Magdelijns FJH, Heymans SRB; CAPACITY-COVID collaborative consortium. Age is the main determinant of COVID-19 related in-hospital mortality with minimal impact of pre-existing comorbidities, a retrospective cohort study. BMC Geriatr. 2022 Mar 5;22(1):184. doi: 10.1186/s12877-021-02673-1.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D000086382	COVID-19
D002318	Cardiovascular Diseases