Clinical Trial

Prognotic Role of CMR in Takotsubo Syndrome

Study acronym: EVOLUTION
Recruiting
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-02-21; most recent amendment 2025-06-04.
Trial Details
NCT Number NCT06277297
Lead Sponsor University of Cagliari
Collaborators: Centro Cardiologico Monzino, IRCCS San Raffaele, University of Roma La Sapienza, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, University of Messina, University of Udine, Vannini Hospital Rome, A.O.U. Città della Salute e della Scienza - Molinette Hospital, University Hospital, Bonn, University Hospital, Rouen
Conditions Takotsubo Cardiomyopathy, Machine Learning, Magnetic Resonance Imaging
Enrollment 350 participants
Start Date 2022-11-09
Primary Completion 2026-11 (estimated)
Study Completion 2032-11 (estimated)
Updated on ClinicalTrials.gov 2025-06-08