Takotsubo SyndromePol-TakoNCT04634487
Polish Registry of Takotsubo Syndrome
An observational study of Takotsubo Syndrome, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Polish registry of takotsubo syndrome Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Takotsubo Syndrome
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2020to Jan 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients hospitalised with takotsubo syndrome in Poland
Who may be able to join
- all patients with takotsubo syndrome
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw
Monika Budnik
Radosław Piątkowski, PhD
About this study
Polish registry of takotsubo syndrome
- Conditions
- Takotsubo Syndrome
- Being tested
- No intervention
- Medical subject headings
- Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with in-hospital complications and mortality
In hospital complications include atrial fibrillation, ventricular tachycardia, ventricular fibrillation, atrioventricular block, cardiogenic shock, cardiac arrest
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Number of participants with complications with echocardiography
Complications include: severe mitral regurgitation, fluid in the pericardium, right ventricle disfunction, ventricular septum rupture
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Oct 2020
- Primary completionOct 2021 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takotsubo SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Budnik, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634487
- Sponsor's protocol ID
- Pol-Tako
- Acronym
- Pol-Tako
- Status last verified
- Nov 2020
- First submitted
- 9 Oct 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Registry of Takotsubo Syndrome
- ClinicalTrials.gov ID
- NCT04634487
- Acronym / sponsor ID
- Pol-Tako / Pol-Tako
- Conditions
- Takotsubo Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 18 Nov 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.
Polish registry of takotsubo syndrome
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalised with takotsubo syndrome in Poland
Key inclusion criteria (1 listed)
- all patients with takotsubo syndrome
Key exclusion criteria (1 listed)
- -
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 | Other | – |
Primary outcome
Number of participants with in-hospital complications and mortality
Time frame: through study completion, an average of 1 year
In hospital complications include atrial fibrillation, ventricular tachycardia, ventricular fibrillation, atrioventricular block, cardiogenic shock, cardiac arrest
1 secondary outcome
Number of participants with complications with echocardiography
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Takotsubo Syndrome, run by Medical University of Warsaw at 1 site in Poland.
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: looking for participants now, as of the sponsor's last update on 18 Nov 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monika Budnik, PhD (+48225991958, mbudnik@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with in-hospital complications and mortality (time frame: through study completion, an average of 1 year). 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 18 Nov 2020.