NCT06277297|Recruiting
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
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EVOLUTION
Exploring the eVolution in prognOstic capabiLity of mUlti-sequence Cardiac magneTIc resOnance in patieNts Affected by Takotsubo Cardiomyopathy
Sponsor study identifier
observational
350
1 country
1
Study Start
November 9, 2022
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 9, 2022
Actual (reported)February 9, 2024
Actual (reported)February 26, 2024
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Takotsubo syndrome patients
University of Cagliari
Cagliari, Italy, 09100, Italy
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.
Cau R, Arcari L, Pontone G, Muscogiuri G, Gatti M, Montisci R, Luetkens J, Normant S, Catapano F, D'Angelo T, Faletti R, Bischoff L, Esposito A, Meloni A, Ciolina F, Negri F, Lisi C, Imazio M, Palmisano A, Marchetti MF, Galea N, Volpe A, Blandino A, Pambianchi G, Clemente A, Dacher JN, Saba L; EVOLUTION group. Right Ventricular Impairment Prevalence in Takotsubo Syndrome and Associated Clinical Characteristics and Outcomes: EVOLUTION Registry Results. Radiol Cardiothorac Imaging. 2026 Apr;8(2):e250494. doi: 10.1148/ryct.250494.
First Submitted
February 9, 2024
First Posted
February 26, 2024
Study Start
November 9, 2022
Actual (reported)Primary Completion
November 2026
EstimatedAutonomic Modulation in Takotsubo Syndrome
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 8, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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