Clinical trial NCT01944826: The TAKO-TSUBO And Cancer 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tako-Tsubo Cardiomyopathy
Stress-induced Cardiomyopathy
Acute Coronary Syndrome
Keywords: Dyspnea
Angina pectoris
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data will be collected on approximately 800 subjects with TTC.

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 description: 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 followed at 6 months and annually after the index event for up to 5 years by phone call, office visit, or by contacts with primary physicians or referring cardiologists, according to each investigator's preference.

As regulated by data protection and privacy laws and in accordance with local ethics committee requirements, subjects will be informed and requested to grant their approval after the index procedure (= cardiac catheterization for suspected acute coronary syndrome) to review their medical records and collect and analyze personal medical information. The confidentiality of the records will be maintained at all times. Subjects will be asked to agree to perform a cancer screening during index hospitalization and will also be asked to agree to be contacted during the 5-year follow-up period.

Patients in whom TTC was diagnosed will be informed and requested to grant their approval to review their medical records, to collect and analyze personal medical information, while maintaining the confidentiality of the records at all times. Subjects will be asked to agree to perform a cancer screening during index hospitalization and will also be asked to agree to be contacted during the 5-year follow-up period. Informed consent will be requested after the index procedure (= cardiac catheterization for suspected acute coronary syndrome proving presence of TTC) and the informed consent form (ICF) has to be signed prior to entering subject's data in the database or prior to any follow-up contact, whichever occurs first.

The investigator and/or designee must clearly document the process of obtaining informed consent in the subject's source documents. The voluntary process of obtaining informed consent confirms the subject's willingness to participate in the registry. It is the investigator's responsibility to ensure that the informed consent process is performed in accordance with Good Epidemiological Practice (GEP) - IEA Guidelines for proper conduct of epidemiological research and where applicable country regulations.

Subjects will be followed at 6 months and annually after the index event for up to 5 years by phone calls, office visits, or by contacts with general practitioners or referring cardiologists, according to each investigator's preference.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* myocardial infarction/ heart attack

Primary outcomes:
measure: prevalence and incidence of cancer in patients with TTC
timeFrame: 5 years
Secondary outcomes:
measure: causes of death during hospital stay and during follow-up
timeFrame: 5 years
Other outcomes:
measure: possible predictors of short and long-term mortality in patients with TTC
timeFrame: 5 years
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum München
name: Christof Burgdorf, Dr.
role: PRINCIPAL_INVESTIGATOR
References: