Prognotic Role of CMR in Takotsubo Syndrome

NCT06277297 | Recruiting

• 1 other identifier: NP/2022/4583
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

Conditions

Takotsubo Cardiomyopathy; Machine Learning; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Takotsubo syndrome patients

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

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

Study Sites (1)

University of Cagliari

Cagliari, Italy, 09100, Italy

RECRUITING

Related Publications (1)

• 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 Nov 1;38(6):391-398. doi: 10.1097/RTI.0000000000000709. Epub 2023 Apr 4.

  PMID: 37015834 BACKGROUND

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Central Study Contacts

Riccardo Cau, MD

CONTACT

+3393493317; riccardo.cau@unica.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 26, 2024
• Study Start: November 9, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2032
• Last Updated: June 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)