The TAKO-TSUBO And Cancer Registry (TTAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01944826
First received: September 13, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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 Intervention
Tako-Tsubo Cardiomyopathy
Stress-induced Cardiomyopathy
Acute Coronary Syndrome
Other: Registry of patients with Tako-Tsubo cardiomyopathy

Study Type: Observational [Patient Registry]
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • prevalence and incidence of cancer in patients with TTC [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • causes of death during hospital stay and during follow-up [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • possible predictors of short and long-term mortality in patients with TTC [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 800
Study Start Date: February 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tako-Tsubo And Cancer Registry Other: Registry of patients with Tako-Tsubo cardiomyopathy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01944826     History of Changes
Other Study ID Numbers: TTAC
Study First Received: September 13, 2013
Last Updated: September 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
Dyspnea
Angina pectoris

Additional relevant MeSH terms:
Takotsubo Cardiomyopathy
Acute Coronary Syndrome
Cardiomyopathies
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Ventricular Dysfunction
Ventricular Dysfunction, Left

ClinicalTrials.gov processed this record on October 21, 2014