NCT04483843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

6 months

First QC Date

August 3, 2019

Last Update Submit

July 26, 2020

Conditions

Pulmonary Edema Cardiac Cause

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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

No interventionOTHER

No intervention will be performed while it is retrospective observational study.

CPE patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • Dyspnea from other cause than cardiogenic pulmonary edema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Medical Service of the Central Bohemian Region

Beroun, Central Bohemia, Czechia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Roman Skulec, MD, PhD

    Emergency Medical Service of the Central Bohemian Region, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 3, 2019

First Posted

July 23, 2020

Study Start

March 1, 2019

Primary Completion

August 31, 2019

Study Completion

September 30, 2019

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

No sharing anticipated.

Locations

CZ(1)