Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06669962

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Tako Tsubo Cardiomyopathy Cardiomyopathies Cardiovascular Diseases Heart Diseases Takotsubo Cardiomyopathy Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Città della Salute e della Scienza

Turin, 10126, Italy

Location status: Recruiting

Location contact

Ovidio De Filippo

CONTACT

[email protected]

+390116336023

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Incidence of coronary microcirculation dysfunction

    Time frame: 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 outcomes

  1. Incidence of in-hospital mortality

    Time frame: up to thirty days

    all-cause death

  2. Correlation between the levels of biomarkers analysed and microvascular dysfunction

    Time frame: 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

  3. Perceived quality of life

    Time frame: 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).

  4. Severity of angina

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ovidio De Filippo, MD

CONTACT

[email protected]

+390116336023

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: TAKO-PROVE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.