Clinical Trial: The TAKO-TSUBO And Cancer Registry
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational [Patient Registry]
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.
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.
Detailed Summary:
The prognosis of patients with TTC is believed to be favorable. This assumption is mainly based on the observations of a rapid recovery of global left ventricular function and low cardiac in-hospital mortality. In fact, the clinical course following TTC events after hospital discharge is largely unknown due to a lack of large prospective long-term follow-up studies and inconsistent and limited findings from available studies to date.
The TTAC registry represents the first attempt to initiate an international registry with special focus on comorbidities, particularly malignancies, in patients with TTC to further elucidate the relationship between these diseases. In addition, the TTAC registry will enable documenting the exact underlying causes of death and long-term prognosis of patients with TTC and to identify possible predictors of short and long-term mortality in these patients.
The first objective of this prospective, multicenter, observational registry is to evaluate the prevalence and incidence of cancer in patients with TTC.
The second objective is to document the underlying causes of death during hospital stay and follow-up and to determine the long-term prognosis of patients with TTC.
The third objective is to identify possible predictors of short and long-term mortality in patients with TTC.
Available information is collected from subjects being treated according to routine clinical practice. In addition, during the index hospitalization, each subject is screened for occult cancer disease. During follow-up, cancer screening will be performed according to appropriate legal preventive examinations.
Subjects will be fol
Sponsor: Deutsches Herzzentrum Muenchen
Current Primary Outcome: prevalence and incidence of cancer in patients with TTC [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: causes of death during hospital stay and during follow-up [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: Deutsches Herzzentrum Muenchen
Dates:
Date Received: September 13, 2013
Date Started: February 2011
Date Completion: February 2016
Last Updated: September 13, 2013
Last Verified: September 2013
