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

Recruiting

• Conditions: Tako Tsubo Cardiomyopathy

• Registration Number: NCT06669962
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-04
• Study Start: 2024-07-10
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Primary Completion: 2026-06-27
• Study Completion: 2027-06-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of coronary microcirculation dysfunction	one year	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

Secondary Outcome Measures

Name	Time	Method
Incidence of in-hospital mortality	up to thirty days	all-cause death
Correlation between the levels of biomarkers analysed and microvascular dysfunction	at discharge (assessed up to 5 days)	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
Perceived quality of life	one year	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).
Severity of angina	one year	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

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza; 🇮🇹 Turin, Italy