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

NCT06669962 | Recruiting

• 1 other identifier: AOUCitta
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  one year

Secondary Outcomes (4)

• Incidence of in-hospital mortality

  up to thirty days

• Correlation between the levels of biomarkers analysed and microvascular dysfunction

  at discharge (assessed up to 5 days)

• Perceived quality of life

  one year

• Severity of angina

  one year

Interventions

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

AOU Città della Salute e della Scienza

Turin, Turin, 10126, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood sample

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Central Study Contacts

Ovidio De Filippo, MD

CONTACT

+390116336023; odefilippo@cittadellasalute.to.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: November 1, 2024
• Study Start: July 10, 2024
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): June 27, 2027
• Last Updated: November 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)