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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04361994
Other study ID # 00
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2015
Est. completion date January 2025

Study information

Verified date May 2024
Source University of Luebeck
Contact Ingo Eitel, Prof. Dr.
Phone 004945150044501
Email ingo.eitel@uksh.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

GEIST is a multicenter, international observational registry of patients with Takotsubo syndrome. Data regarding the clinical profile (demographic characteristics, clinical presentation, laboratory measures, electrocardiography /echocardiography / coronary angiography parameters, treatment and medication), in-hospital course and complications and short-/long-term outcome are collected prospectively and retrospectively to increase the understanding of the disease.


Description:

The open-ended, multicenter, international GEIST registry collects data from patients with Takotsubo syndrome during the index hospitalization and follow-up. Furthermore, long-term outcome data are acquired with structured telephone interviews, in case patients do not undergo regular outpatient visits in the participating study centers. The GEIST registry retrospectively includes data, which have already been collected, and prospectively continues to enroll patients with newly diagnosed Takotsubo syndrome.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with Takotsubo syndrome Exclusion Criteria: - Non

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Universität zu Lübeck Lübeck Schleswig-Holstein
Italy University of Foggia Foggia

Sponsors (2)

Lead Sponsor Collaborator
Prof. Dr. med. Ingo Eitel University of Foggia

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality All-cause mortality (in-hospital, short-term, long-term) Day 0
Primary All-cause mortality All-cause mortality (in-hospital, short-term, long-term) 3 Month
Primary All-cause mortality All-cause mortality (in-hospital, short-term, long-term) 6 Month
Secondary In-Hospital complications Cardiogenic shock, pulmonary edema, death, life-threatening arrhythmias, ventricular thrombus formation, right ventricular involvement Day 0
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