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Characterisation of the Biochemical Profile and Physiology of the Coronary Circulation in Takotsubo Syndrome (TAKO-PROVE)

A

A.O.U. Città della Salute e della Scienza

Status

Enrolling

Conditions

Tako Tsubo Cardiomyopathy

Treatments

Diagnostic Test: Study of coronary microcirculation and biomarkers of microvascular dysfunction

Study type

Observational

Funder types

Other

Identifiers

NCT06669962
AOUCitta

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years;
  • Diagnosis of Takotsubo syndrome
  • Signing of informed consent

Exclusion criteria

  • Age <18 years;
  • Refusal to sign written informed consent.

Trial contacts and locations

1

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Central trial contact

Ovidio De Filippo, MD

Data sourced from clinicaltrials.gov

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