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Prognotic Role of CMR in Takotsubo Syndrome

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06277297
Acronym
EVOLUTION
Enrollment
350
Registered
2024-02-26
Start date
2022-11-09
Completion date
2032-11-30
Last updated
2025-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Machine Learning, Magnetic Resonance Imaging, Takotsubo Cardiomyopathy

Brief summary

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

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality2 yearscardiovascular 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.

Countries

Italy

Contacts

Primary ContactRiccardo Cau, MD
riccardo.cau@unica.it+3393493317

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026