Characterisation of the Biochemical Profile and Physiology of the Coronary Circulation in Takotsubo Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorA.O.U. Città della Salute e della Scienza

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Diagnosis of Takotsubo syndrome

Signing of informed consent

Disqualifiers

Age <18 years;

Refusal to sign written informed consent.

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Study of coronary microcirculation and biomarkers of microvascular dysfunction

    Diagnostic test

    Patients with tako-tsubo syndrome will undergo to coronary angiography, ventriculography and assessment of physiological indexes of coronary circulation as per clinical practice

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Incidence of in-hospital mortality

all-cause death

Time frame
up to thirty days
2

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)
3

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
4

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

Other outcomes

Sponsors and contacts

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