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NCT Number: NCT06277297

Prognotic Role of CMR in Takotsubo Syndrome

The primary objective of this observational registry is to develop a comprehensive clinical and imaging score (incorporating echocardiography and cardiac magnetic resonance data) that enhances risk stratification for patients with Takotsubo syndrome.

The secondary objectives of this registry are as follows:

Investigate the diagnostic value of cardiac magnetic resonance parameters in predicting in-hospital and long-term outcomes in patients with Takotsubo syndrome.

Compare the proposed risk stratification score for patients with Takotsubo syndrome with previously existing scores.

Investigate the contribution of machine learning models in predicting in-hospital and long-term outcomes compared to standard clinical scores.

The design and rationale of this registry are available at 10.1097/RTI.0000000000000709

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cagliari

Cagliari, Italy, 09100

Location status: Recruiting

Location contact

Luca Saba

PRINCIPAL_INVESTIGATOR

Riccardo Cau

CONTACT

[email protected]

+393393493317

Riccardo Cau

PRINCIPAL_INVESTIGATOR

About this study

The prognosis of Takotsubo syndrome patients remains contentious, necessitating improved risk stratification for better management. While various clinical characteristics and parameters from transthoracic echocardiography have been associated with outcomes, none of the existing predictive scores incorporate cardiac magnetic resonance imaging (CMR) data, despite its ability to noninvasively assess tissue characterization. CMR offers a comprehensive evaluation of functional and structural changes, including an accurate assessment of right ventricular function. While CMR has been extensively studied for diagnostic purposes in Takotsubo syndrome, its role in prognosis is still debated. Emerging technologies like computed tomography show promise in myocardial characterization but lack robust investigation in prognostic roles. The EVOLUTION registry aims to address this gap by incorporating CMR parameters into a risk stratification score alongside clinical and transthoracic echocardiography data, with machine learning models also explored for enhanced outcome prediction. This initiative seeks to provide a more reliable predictive tool for the optimized management of Takotsubo syndrome patients. The main objective of this study is to enhance risk assessment in Takotsubo syndrome patients by incorporating CMR data alongside demographic, clinical, and transthoracic echocardiography parameters. Specifically, the aim is to analyze CMR data and their association with both short-term and long-term patient outcomes. Additionally, the effectiveness of the proposed risk stratification score for Takotsubo syndrome patients will be evaluated in comparison to existing scoring systems. Moreover, all available CMR, transthoracic echocardiography, and clinical variables will be utilized to develop machine learning models for predictive analysis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Takotsubo syndrome diagnosis (according to Position Statement of the European Society of Cardiology Heart Failure Association)
  • Adult patients ( > 18y old)
  • Availability at baseline of clinical variables, standard transthoracic echocardiography, and cardiovascular magnetic resonance acquisition

Exclusion criteria

  • <18 y old
  • Lack of transthoracic echocardiography and cardiovascular magnetic resonance examinations
  • Preexisting cardiomyopathies
  • Previous myocardial infarction
  • Suspected or known prior irreversible myocardial damage
  • Valvular heart disease

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 2 years

    cardiovascular death, pulmonary edema, arrhythmias, heart failure, sudden car- diac death, and major adverse cardiac and cerebrovascular events (MACCE) defined as a composite endpoint of death from any cause, myocardial infarction, recurrence of Takotsubo syndrome, transient ischemic attack, and stroke.

Study contacts

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

Riccardo Cau, MD

CONTACT

[email protected]

+3393493317

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Collaborators

  • A.O.U. Città della Salute e della Scienza - Molinette Hospital
  • Centro Cardiologico Monzino
  • Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
  • IRCCS San Raffaele
  • University Hospital, Bonn
  • University Hospital, Rouen
  • University of Messina
  • University of Roma La Sapienza
  • University of Udine
  • Vannini Hospital Rome

Registry information

Official study title

Exploring the eVolution in prognOstic capabiLity of mUlti-sequence Cardiac magneTIc resOnance in patieNts Affected by Takotsubo Cardiomyopathy

Acronym: EVOLUTION

Important dates

Study start
2022
Primary completion
2026
Study completion
2032
First posted
Feb 26, 2024
Registry last updated
Jun 8, 2025

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.

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