Prognotic Role of CMR in Takotsubo Syndrome (EVOLUTION)

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

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

Study Overview

• Status: Recruiting
• Conditions: Magnetic Resonance Imaging; Machine Learning; Takotsubo Cardiomyopathy

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

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Riccardo Cau, MD; Phone Number: +3393493317; Email: riccardo.cau@unica.it

Study Locations

• Italy
  • Cagliari, Italy, 09100
    • Recruiting
    • University of Cagliari
    • Contact: Riccardo Cau; Phone Number: +393393493317; Email: riccardo.cau@unica.it
    • Principal Investigator: Luca Saba
    • Principal Investigator: Riccardo Cau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Takotsubo syndrome patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	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.	2 years

Collaborators and Investigators

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

Publications and helpful links

General 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 the EVOLUTION Study. J Thorac Imaging. 2023 Apr 4. doi: 10.1097/RTI.0000000000000709. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2032

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Left; Cardiomyopathies; Takotsubo Cardiomyopathy
• Other Study ID Numbers: NP/2022/4583

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No