NCT06669962

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: A.O.U. Città della Salute e della Scienza · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tako Tsubo Cardiomyopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-10
• Primary completion: 2026-06-27
• Completion: 2027-06-27
• First posted: 2024-11-01
• Last updated: 2024-11-01

Locations

1 site across 1 country: Italy