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The GErman Italian Spanish Takotsubo (GEIST) Registry (GEIST)

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ClinicalTrials.gov Identifier: NCT04361994
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
University of Foggia
Information provided by (Responsible Party):
Prof. Dr. med. Ingo Eitel, University of Luebeck

Study Description
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Brief 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.

Condition or disease
Takotsubo Syndrome

Detailed 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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: The GErman Italian Spanish Takotsubo (GEIST) Registry
Actual Study Start Date : April 2015
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Day 0 ]
    All-cause mortality (in-hospital, short-term, long-term)

  2. All-cause mortality [ Time Frame: 3 Month ]
    All-cause mortality (in-hospital, short-term, long-term)

  3. All-cause mortality [ Time Frame: 6 Month ]
    All-cause mortality (in-hospital, short-term, long-term)


Secondary Outcome Measures :
  1. In-Hospital complications [ Time Frame: Day 0 ]
    Cardiogenic shock, pulmonary edema, death, life-threatening arrhythmias, ventricular thrombus formation, right ventricular involvement


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed according to the current diagnostic recommendations at the time of clinical presentation
Criteria

Inclusion Criteria:

  • Patients with Takotsubo syndrome

Exclusion Criteria:

  • Non
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361994


Contacts
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Contact: Ingo Eitel, Prof. Dr. 004945150044501 ingo.eitel@uksh.de
Contact: Thomas Stiermaier, Dr.

Locations
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Germany
Universität zu Lübeck Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Ingo Eitel, Prof. Dr. med.         
Contact: Thomas Stiermaier, Dr.med         
Italy
University of Foggia Recruiting
Foggia, Italy
Contact: Franceso Santoro, Dr.         
Contact: Daniele Brunetti, Prof. Dr.         
Sponsors and Collaborators
Prof. Dr. med. Ingo Eitel
University of Foggia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. med. Ingo Eitel, Director, University of Luebeck
ClinicalTrials.gov Identifier: NCT04361994    
Other Study ID Numbers: 00
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Takotsubo Cardiomyopathy
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases