Takotsubo CardiomyopathyEVOLUTIONNCT06277297
Prognotic Role of CMR in Takotsubo Syndrome
An observational study of Takotsubo Cardiomyopathy and Machine Learning, run by University of Cagliari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takotsubo Cardiomyopathy, Machine Learning, Magnetic Resonance Imaging
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 9 Nov 2022to Nov 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Takotsubo syndrome patients
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Cagliari
Cagliari, Italy, 09100
Riccardo Cau, +393393493317, riccardo.cau@unica.it
Luca Saba
About this study
Official title: 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:
Read more
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
Read the 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
- Medical subject headings
- Takotsubo Cardiomyopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start9 Nov 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Takotsubo CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Riccardo Cau, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277297
- Sponsor's protocol ID
- NP/2022/4583
- Acronym
- EVOLUTION
- Status last verified
- Mar 2025
- First submitted
- 9 Feb 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Nov 1;38(6):391-398. doi: 10.1097/RTI.0000000000000709. Epub 2023 Apr 4.
PubMed 37015834Cau 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.
PubMed 41989283
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the eVolution in prognOstic capabiLity of mUlti-sequence Cardiac magneTIc resOnance in patieNts Affected by Takotsubo Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06277297
- Acronym / sponsor ID
- EVOLUTION / NP/2022/4583
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- 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
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Takotsubo syndrome patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- <18 y old
- Lack of transthoracic echocardiography and cardiovascular magnetic resonance examinations
- Preexisting cardiomyopathies
- Previous myocardial infarction
- Suspected or known prior irreversible myocardial damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Results publication: PubMed 37015834Cau 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.
- Derived from this study: PubMed 41989283Cau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takotsubo Cardiomyopathy and Machine Learning, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Cau, MD (+3393493317, riccardo.cau@unica.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06277297, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.