Pulmonary Edema Cardiac CauseNCT04483843
Cosmic Weather and Cardiogenic Pulmonary Edema
An observational study of Pulmonary Edema Cardiac Cause, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Edema Cardiac Cause
- How many people
- 4,000 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- All patients treated by Emergency Medical Service of the Central Bohemian Region for cardiogenic pulmonary edema between 1.10.2008 and 30.6.2014.
Who cannot join
- Dyspnea from other cause than cardiogenic pulmonary edema.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Emergency Medical Service of the Central Bohemian Region
Beroun, Central Bohemia
About this study
Official title: Impact of Cosmic Weather on Pre-hospital Incidence of Cardiogenic Pulmonary Edema
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.
Read the 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.
- Conditions
- Pulmonary Edema Cardiac Cause
- Being tested
- No intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be performed while it is retrospective observational study.
| Study group | Role | What they receive |
|---|---|---|
| CPE patients | All patients prehospitally treated for cardiogenic pulmonary edema in the pre-hospital emergency setting in the Central Bohemian region, Czech Republic. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant correlation between incidence of CPE and activity of the space weather
Significant correlation between incidence of CPE and activity of the space weather
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Mar 2019
- Primary completion31 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Edema Cardiac CauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem, Institute of Experimental Physics, Slovak Academy of Sciences
- Responsible party
- Principal investigator, Roman Skulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Investigators
- Roman Skulec, MD, PhD, Principal investigator, Emergency Medical Service of the Central Bohemian Region, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483843
- Sponsor's protocol ID
- 2019-03
- Status last verified
- Jul 2020
- First submitted
- 3 Aug 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing anticipated.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cosmic Weather on Pre-hospital Incidence of Cardiogenic Pulmonary Edema
- ClinicalTrials.gov ID
- NCT04483843
- Acronym / sponsor ID
- 2019-03
- Conditions
- Pulmonary Edema Cardiac Cause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem, Institute of Experimental Physics, Slovak Academy of Sciences
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPE patients | – | Other: No interventionAll patients prehospitally treated for cardiogenic pulmonary edema in the pre-hospital emergency setting in the Central Bohemian region, Czech Republic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- All patients treated by Emergency Medical Service of the Central Bohemian Region for cardiogenic pulmonary edema between 1.10.2008 and 30.6.2014.
Key exclusion criteria (1 listed)
- Dyspnea from other cause than cardiogenic pulmonary edema.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention will be performed while it is retrospective observational study. | Other | CPE patients |
Primary outcome
Significant correlation between incidence of CPE and activity of the space weather
Time frame: 4 years
Significant correlation between incidence of CPE and activity of the space weather
Significant correlation between incidence of CPE and the degree of the geomagnetic field disturbance
Time frame: 4 years
Significant correlation between incidence of CPE and the degree of the geomagnetic field disturbance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No. No sharing anticipated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Skulec, MD, PhD principal investigator
Emergency Medical Service of the Central Bohemian Region, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Edema Cardiac Cause, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant correlation between incidence of CPE and activity of the space weather (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.