An observational study in Tako Tsubo Cardiomyopathy, sponsored by A.O.U. Città della Salute e della Scienza. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by A.O.U. Città della Salute e della Scienza · Observational
Consecutive consenting patients over the age of 18 years diagnosed with Takotsubo syndrome according to the position statement of the European Journal of Heart Failure (2016) will be included in the study. The primary endpoint is to evaluate the incidence of coronary microcirculation dysfunction and its correlation with the clinical presentation and the prognosis in patients with TAKO-Tsubo syndrome. Secondary endpoints will be to assess the incidence of in-hospital mortality, the prevalence of cardiogenic shock, the correlation between the levels of biomarkers analyzed, microvascular dysfunction, perceived quality of life, and angina severity during hospitalization and at subsequent follow-ups, and the influence of knowledge of the level of microvascular dysfunction on clinical management and prescribed therapies. Enrolment: 2 years, follow-up: 1 month and 1 year. Total: 3 years.
63 studies on the registry are indexed under Takotsubo Cardiomyopathy; 26 are open to participants now.
This study's planned enrollment of 50 is below the median of 250 across 39 observational studies indexed under Takotsubo Cardiomyopathy.
Browse Takotsubo Cardiomyopathy studies →A.O.U. Città della Salute e della Scienza is the lead sponsor of 65 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive consenting patients over the age of 18 years with a diagnosis of Takotsubo syndrome will be included in the study according to the position statement of the European Journal of Heart Failure (2016).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with tako-tsubo syndrome will undergo to coronary angiography, ventriculography and assessment of physiological indexes of coronary circulation as per clinical practice
Incidence of coronary microcirculation dysfunction
coronary microvascular dysfunztion will be defined as a coronary flow reserve (CFR) \< 2.5 and/or as an index of microvascular resistance (IMR) \> 25 , as assessed with Coroventis syestem
Time frame: one year
Incidence of in-hospital mortality
all-cause death
Time frame: up to thirty days
Correlation between the levels of biomarkers analysed and microvascular dysfunction
Several biomarkers (namely neuropeptide Y, troponin I, nt-pro BNP) will be measured via center-specific labratory essays) and a correlation of their blood levels with coronary microvascular dysfunction ( coronary flow reserve (CFR) and index of microvascular resistance (IMR) assessed with Coroventis system) will be sought
Time frame: at discharge (assessed up to 5 days)
Perceived quality of life
Assessed with Euro Quality of life scale 5D (EQOL-5d): EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort,and anxiety/depression. The answers given to ED-5D permitto find 243 unique health states or can be converted into EQ-5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possiblehealth status).
Time frame: one year
Severity of angina
assessed with the Seattle Angina Questionnaire (SAQ): This SAQ quantifies 5 domains measuring the impact of angina on patients' health status: Physical Limitation (9 items), Angina Stability (1item), Angina Frequency (2 items), Treatment Satisfaction (4 items), and Quality of Life (3 items). Item responses are coded sequentially from worst to best status and range from 1 to 6 for Physical Limitation, Angina Stability, and Angina Frequency items; 1 to 5/6 for Treatment Satisfaction items; and 1 to 5 for Quality of Life items
Time frame: one year
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Jun 2026, 23 months after the start.
Of 25 observational studies under Takotsubo Cardiomyopathy, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 40. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
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A.O.U. Città della Salute e della Scienza