Characterisation of the Biochemical Profile and Physiology of the Coronary Circulation in Takotsubo Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Study of coronary microcirculation and biomarkers of microvascular dysfunction.
- Who it may be relevant to
- Registry conditions: Tako Tsubo Cardiomyopathy. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Study of coronary microcirculation and biomarkers of microvascular dysfunction
Patients with tako-tsubo syndrome will undergo to coronary angiography, ventriculography and assessment of physiological indexes of coronary circulation as per clinical practice
Primary outcome measures
- Incidence of coronary microcirculation dysfunction [Time frame: one year]
Secondary outcome measures (4)
- Incidence of in-hospital mortality [Time frame: up to thirty days]
- Correlation between the levels of biomarkers analysed and microvascular dysfunction [Time frame: at discharge (assessed up to 5 days)]
- Perceived quality of life [Time frame: one year]
- Severity of angina [Time frame: one year]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years;
- Diagnosis of Takotsubo syndrome
- Signing of informed consent
Exclusion criteria
- Age <18 years;
- Refusal to sign written informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- AOU Città della Salute e della Scienza — Turin
Identifiers
NCT: NCT06669962 · AOUCitta