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

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.

Study Overview

• Status: Recruiting
• Conditions: Tako Tsubo Cardiomyopathy
• Intervention / Treatment: Diagnostic test: Study of coronary microcirculation and biomarkers of microvascular dysfunction

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ovidio De Filippo, MD; Phone Number: +390116336023; Email: odefilippo@cittadellasalute.to.it

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • AOU Città della Salute e della Scienza
    • Contact: Ovidio De Filippo; Phone Number: +390116336023; Email: odefilippo@cittadellasalute.to.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): June 27, 2027

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Left; Cardiomyopathies; Takotsubo Cardiomyopathy
• Other Study ID Numbers: AOUCitta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No