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Recruiting NCT06277297

Prognotic Role of CMR in Takotsubo Syndrome

— Observational Takotsubo Cardiomyopathy Machine Learning Magnetic Resonance Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Takotsubo Cardiomyopathy, Machine Learning, Magnetic Resonance Imaging. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed description

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

Primary outcome measures

  • All-cause mortality [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • University of Cagliari — Cagliari

Publications

  • Cau R, Muscogiuri G, Pisu F, Gatti M, Velthuis B, Loewe C, Cademartiri F, Pontone G, Montisci R, Guglielmo M, Sironi S, Esposito A, Francone M, Dacher N, Peebles C, Bastarrika G, Salgado R, Saba L. Exploring the EVolution in PrognOstic CapabiLity of MUltisequence Cardiac MagneTIc ResOnance in PatieNts Affected by Takotsubo Cardiomyopathy Based on Machine Learning Analysis: Design and Rationale of PMID 37015834
  • Cau R, Arcari L, Pontone G, Muscogiuri G, Gatti M, Montisci R, Luetkens J, Normant S, Catapano F, D'Angelo T, Faletti R, Bischoff L, Esposito A, Meloni A, Ciolina F, Negri F, Lisi C, Imazio M, Palmisano A, Marchetti MF, Galea N, Volpe A, Blandino A, Pambianchi G, Clemente A, Dacher JN, Saba L; EVOLUTION group. Right Ventricular Impairment Prevalence in Takotsubo Syndrome and Associated Clinical Ch PMID 41989283

Identifiers

NCT: NCT06277297 · NP/2022/4583

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗