The TAKO-TSUBO And Cancer Registry

NCT01944826 | Unknown

• 1 other identifier: TTAC
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Tako-Tsubo Cardiomyopathy; Stress-induced Cardiomyopathy; Acute Coronary Syndrome

Keywords

Dyspnea; Angina pectoris

Outcome Measures

Primary Outcomes (1)

• prevalence and incidence of cancer in patients with TTC

  5 years

Secondary Outcomes (1)

• causes of death during hospital stay and during follow-up

  5 years

Other Outcomes (1)

• possible predictors of short and long-term mortality in patients with TTC

  5 years

Study Arms (1)

Tako-Tsubo And Cancer Registry

Other: Registry of patients with Tako-Tsubo cardiomyopathy

Interventions

Registry of patients with Tako-Tsubo cardiomyopathy OTHER

Tako-Tsubo And Cancer Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data will be collected on approximately 800 subjects with TTC.

You may qualify if:

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

You may not qualify if:

• myocardial infarction/ heart attack

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (1)

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

RECRUITING

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

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Acute Coronary Syndrome; Dyspnea; Angina Pectoris

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Myocardial Ischemia; Vascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chest Pain; Pain; Neurologic Manifestations

Study Officials

• Christof Burgdorf, Dr.

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christof Burgdorf, Dr.

CONTACT

+49-89-1218-4027; burgdorf@dhm.mhn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 18, 2013
• Study Start: February 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

DE (1)