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

NCT ID: NCT06669962

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2027-06-27

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AOU Città della Salute e della Scienza

Turin, Turin, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Ovidio De Filippo, MD

Role: CONTACT

odefilippo@cittadellasalute.to.it

+390116336023

Facility Contacts

Ovidio De Filippo

Role: primary

odefilippo@cittadellasalute.to.it

+390116336023

Other Identifiers

AOUCitta

Identifier Type: -

Identifier Source: org_study_id