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

May 8, 2020 updated by: Prof. Dr. med. Ingo Eitel
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

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

Study Contact Backup

  • Name: Thomas Stiermaier, Dr.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universität zu Lübeck
        • Contact:
          • Ingo Eitel, Prof. Dr. med.
        • Contact:
          • Thomas Stiermaier, Dr.med
  • Italy
      • Foggia, Italy
        • Recruiting
        • University of Foggia
        • Contact:
          • Franceso Santoro, Dr.
        • Contact:
          • Daniele Brunetti, Prof. Dr.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diagnosed according to the current diagnostic recommendations at the time of clinical presentation

Description

Inclusion Criteria:

  • Patients with Takotsubo syndrome

Exclusion Criteria:

  • Non

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Day 0
All-cause mortality (in-hospital, short-term, long-term)
Day 0
All-cause mortality
Time Frame: 3 Month
All-cause mortality (in-hospital, short-term, long-term)
3 Month
All-cause mortality
Time Frame: 6 Month
All-cause mortality (in-hospital, short-term, long-term)
6 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-Hospital complications
Time Frame: Day 0
Cardiogenic shock, pulmonary edema, death, life-threatening arrhythmias, ventricular thrombus formation, right ventricular involvement
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. med. Ingo Eitel

Collaborators

University of Foggia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2015

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 8, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Takotsubo Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe