Cosmic Weather and Cardiogenic Pulmonary Edema | NCT04483843

Studies
Cosmic Weather and Cardiogenic Pulmonary Edema

NCT04483843

Sponsor

Emergency Medical Service of the Central Bohemian Region, Czech Republic

Status

Completed

Last Update Posted

Jul 29, 2020Actual

Enrollment

4,000Actual

Phase

Not provided

Conditions

Pulmonary Edema Cardiac Cause

Interventions

No intervention

Countries

Czechia

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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Aug 31, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Aug 3, 2019

First Submission Date that Met QC Criteria

Jul 20, 2020

First Posted Date

Jul 23, 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

Jul 26, 2020

Last Update Posted Date

Jul 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roman Skulec, Principal investigator, Emergency Medical Service of the Central Bohemian Region, Czech RepublicPrincipal Investigator

Lead Sponsor

Emergency Medical Service of the Central Bohemian Region, Czech RepublicOTHER

Collaborators

Name	Class
Masaryk Hospital Usti nad Labem	OTHER
Institute of Experimental Physics, Slovak Academy of Sciences	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

Retrospective clinical study to evaluate whether there is any correlation between the pre-hospital incidence of cardiogenic pulmonary oedema (CPE) in the selected region and the space weather parameters.

Detailed Description

Emergency Medical Service of the Central Bohemian Region is the exclusive provider of primary pre-hospital emergency care in the Central Bohemian Region, Czech Republic. The region includes both the rural and urban population, in total of 1 315 299 inhabitants on a total area of 11 015 km2. A computer search of patients with dyspnoea between 1.10.2008 and 30.6.2014 will be conducted and all cases of cardiogenic pulmonary oedema will be selected.

Physical parameters of space weather and geomagnetic field disturbances will be obtained from the database of Institute of Experimental Physics, Slovak Academy of Sciences, Slovak Republic. The datasets will be analysed whether there is any correlation between the pre-hospital incidence of CPE in the selected region and the parameters of space weather and geomagnetic field disturbances.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPE patients		All patients prehospitally treated for cardiogenic pulmonary edema in the pre-hospital emergency setting in the Central Bohemian region, Czech Republic.	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention will be performed while it is retrospective observational study.	CPE patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Significant correlation between incidence of CPE and activity of the space weather	Significant correlation between incidence of CPE and activity of the space weather	4 years
Significant correlation between incidence of CPE and the degree of the geomagnetic field disturbance	Significant correlation between incidence of CPE and the degree of the geomagnetic field disturbance	4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients treated by Emergency Medical Service of the Central Bohemian Region for cardiogenic pulmonary edema between 1.10.2008 and 30.6.2014.

Exclusion Criteria:

Dyspnea from other cause than cardiogenic pulmonary edema.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients from the registry of the Emergency Medical Service of the Central Bohemian Region, Czech Republic who were treated prehospitally for cardiogenic pulmonary edema between 1.10.2008 and 30.6.2014.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roman Skulec, MD, PhD	Emergency Medical Service of the Central Bohemian Region, Czech Republic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency Medical Service of the Central Bohemian Region		Beroun	Central Bohemia		Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

No sharing anticipated.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided