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The TAKO-TSUBO And Cancer Registry (TTAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01944826
Recruitment Status : Unknown
Verified September 2013 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
First Posted : September 18, 2013
Last Update Posted : September 18, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Prospective, multicenter, observational registry collecting data from subjects with Tako-Tsubo (stress-induced) cardiomyopathy (TTC). Uniform, complete, and accurate data will be collected on the subject's medical history, during index hospitalization for TTC, and during follow-up.

The objectives are to evaluate the prevalence and incidence of cancer in patients with TTC, to document the underlying causes of death during hospital stay and during follow-up, to determine the long-term prognosis, and to identify possible predictors of short and long-term mortality.


Condition or disease Intervention/treatment
Tako-Tsubo Cardiomyopathy Stress-induced Cardiomyopathy Acute Coronary Syndrome Other: Registry of patients with Tako-Tsubo cardiomyopathy

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective, Multicenter, Observational Registry to Evaluate the Prevalence and Incidence of Cancer and Long-term Prognosis in Patients With Tako-Tsubo (Stress-induced) Cardiomyopathy.
Study Start Date : February 2011
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Tako-Tsubo And Cancer Registry Other: Registry of patients with Tako-Tsubo cardiomyopathy


Outcome Measures

Primary Outcome Measures :
  1. prevalence and incidence of cancer in patients with TTC [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. causes of death during hospital stay and during follow-up [ Time Frame: 5 years ]

Other Outcome Measures:
  1. possible predictors of short and long-term mortality in patients with TTC [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA

Laboratory parameters and biomarkers:

  • Faecal occult blood test
  • Complete blood count including erythrocyte sedimentation rate
  • Serum protein electrophoresis
  • Prostate-specific antigen (PSA) testing in men

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Data will be collected on approximately 800 subjects with TTC.
Criteria

Inclusion Criteria:

  • Tako-Tsubo (stress-induced) cardiomyopathy (TTC)

Exclusion Criteria:

  • myocardial infarction/ heart attack
Contacts and Locations

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): NCT01944826


Contacts
Contact: Christof Burgdorf, Dr. +49-89-1218-4027 burgdorf@dhm.mhn.de

Locations
Germany
Deutsches Herzzentrum München Recruiting
Munich, Bavaria, Germany, 80636
Principal Investigator: Christof Burgdorf, Dr.         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Christof Burgdorf, Dr. Deutsches Herzzentrum München
More Information

Additional Information:
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01944826     History of Changes
Other Study ID Numbers: TTAC
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by Deutsches Herzzentrum Muenchen:
Dyspnea
Angina pectoris

Additional relevant MeSH terms:
Acute Coronary Syndrome
Cardiomyopathies
Takotsubo Cardiomyopathy
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction