University of Cagliari
Cagliari, Italy, 09100
Location status: Recruiting
Location contact
Luca Saba
PRINCIPAL_INVESTIGATOR
Riccardo Cau
CONTACT
Riccardo Cau
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06277297
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Cagliari, Italy, 09100
Location status: Recruiting
Luca Saba
PRINCIPAL_INVESTIGATOR
Riccardo Cau
CONTACT
Riccardo Cau
PRINCIPAL_INVESTIGATOR
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
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.
Contact information is provided by the study sponsor or research team.
University of Cagliari
Other
Exploring the eVolution in prognOstic capabiLity of mUlti-sequence Cardiac magneTIc resOnance in patieNts Affected by Takotsubo Cardiomyopathy
Acronym: EVOLUTION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06332859
Acute Coronary Syndrome, Cardiomyopathies
Bad Tatzmannsdorf, Burgenland, Austria
View Trial DetailsNCT05977049
Cardiomyopathies, Cardiovascular Diseases
New York, United States
View Trial DetailsNCT05946772
Cardiomyopathies, Cardiovascular Diseases
Bad Nauheim, Germany
View Trial DetailsNCT04513054
Cardiomyopathies, Cardiovascular Diseases
Aberdeen, Aberdeenshire, United Kingdom
View Trial Details