- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04634487
Polish Registry of Takotsubo Syndrome (Pol-Tako)
November 12, 2020 updated by: Monika Budnik, Medical University of Warsaw
Polish registry of takotsubo syndrome
Study Overview
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Monika Budnik, PhD
- Phone Number: +48225991958
- Email: mbudnik@wum.edu.pl
Study Locations
-
-
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Warsaw, Poland
- Recruiting
- Medical University of Warsaw
-
Contact:
- Monika Budnik
-
Sub-Investigator:
- Radosław Piątkowski, PhD
-
Principal Investigator:
- Grzegorz Opolski, Prof
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients hospitalised with takotsubo syndrome in Poland
Description
Inclusion Criteria:
all patients with takotsubo syndrome
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with complications with echocardiography
Time Frame: through study completion, an average of 1 year
|
Complications include: severe mitral regurgitation, fluid in the pericardium, right ventricle disfunction, ventricular septum rupture
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
January 1, 2030
Study Registration Dates
First Submitted
October 9, 2020
First Submitted That Met QC Criteria
November 12, 2020
First Posted (Actual)
November 18, 2020
Study Record Updates
Last Update Posted (Actual)
November 18, 2020
Last Update Submitted That Met QC Criteria
November 12, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pol-Tako
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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