Takotsubo SyndromeTINNCT06643949
Italian Multicenter Observational Registry on Takostubo Syndrome
An observational study of Takotsubo Syndrome, run by University of Molise.
Trial summary
Takotsubo syndrome (TTS) has recently been described as an acquired form of cardiomyopathy whose pathophysiology is not yet well understood and mainly affects postmenopausal women. TTS or "broken heart" syndrome was first described in Japan in 1991. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takotsubo Syndrome
- What is being tested?
- Echocardiography
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2037
- How long will I take part?
- 5 Years
- 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: Patients diagnosed with takotsubo syndrome.
Who may be able to join
- Patients diagnosed with TTS in accordance with the InterTAK Diagnostic Criteria.
Who cannot join
- Age less than 18 years
- Myocarditis
- Acute coronary syndrome
- Myocardial infarction with non obstructive coronary arteries (MINOCA)
About this study
Official title: Takotsubo Italian Network: Italian Multicenter Observational Registry on Takostubo Syndrome
Takotsubo syndrome (TTS) has recently been described as an acquired form of cardiomyopathy whose pathophysiology is not yet well understood and mainly affects postmenopausal women. TTS or "broken heart" syndrome was first described in Japan in 1991. The Japanese term "tako-tsubo" means "polyp vessel" and describes the morphology of the left ventricular apex during systole in patients with this condition. The onset usually follows physical or emotional stress and mimics that of acute coronary syndrome (ACS) with a parade of symptoms, including chest pain, dyspnea, syncope, and nausea. Objective examination is often normal or otherwise nonspecific. ECG may document ST-T changes while echocardiogram shows areas of altered ventricular kinetics. Serum cardiac biomarkers may be increased. Currently, the gold standard method for the diagnosis of TTS is coronarography, which documents epicardial coronary arteries that are normal or free of critical lesions.
It is estimated that more than 2.5% of patients with a suspected diagnosis of ACS have TTS, and this number is probably underestimated. Although the prognosis of TTS is generally considered favorable, during the acute phase these patients can develop potentially fatal complications such as ventricular arrhythmias, cardiogenic shock, and heart rupture. Moreover, emerging scientific evidence sheds light on the need to adopt a dedicated diagnostic-therapeutic pathway for this type of patients.
The exact pathophysiology of TTS is still unknown and no large population studies or registries are currently available. Therefore, the purpose of the study is to better characterize the profile of this disease through the creation of a large registry.
- Conditions
- Takotsubo Syndrome
- Being tested
- Echocardiography
- Keywords
- takotsubo, cardiomyopathy, cardiogenic shock, LVOTO, mitral regurgitation, heart failure
- Medical subject headings
- Takotsubo Cardiomyopathy, Cardiomyopathies, Shock, Cardiogenic, Mitral Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
The registry will focus on the diagnostic and prognostic value of of echocardiographic features of patients with takotsubo syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Composite of acute heart failure, takotsubo recurrence and mortality.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jan 2008
- Primary completion31 Dec 2008
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takotsubo SyndromeStudies 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
- Prospective
- Enrolment
- 1,500 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolfo Citro, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643949
- Sponsor's protocol ID
- 141024
- Acronym
- TIN
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Takotsubo Italian Network: Italian Multicenter Observational Registry on Takostubo Syndrome
- ClinicalTrials.gov ID
- NCT06643949
- Acronym / sponsor ID
- TIN / 141024
- Conditions
- Takotsubo Syndrome
- Keywords
- takotsubo, cardiomyopathy, cardiogenic shock, LVOTO, mitral regurgitation, heart failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 16 Oct 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.
Takotsubo syndrome (TTS) has recently been described as an acquired form of cardiomyopathy whose pathophysiology is not yet well understood and mainly affects postmenopausal women. TTS or "broken heart" syndrome was first described in Japan in 1991. The Japanese term "tako-tsubo" means "polyp vessel" and describes the morphology of the left ventricular apex during systole in patients with this condition. The onset usually follows physical or emotional stress and mimics that of acute coronary syndrome (ACS) with a parade of symptoms, including chest pain, dyspnea, syncope, and nausea. Objective examination is often normal or otherwise nonspecific. ECG may document ST-T changes while echocardiogram shows areas of altered ventricular kinetics. Serum cardiac biomarkers may be increased. Currently, the gold standard method for the diagnosis of TTS is coronarography, which documents epicardial coronary arteries that are normal or free of critical lesions.
It is estimated that more than 2.5% of patients with a suspected diagnosis of ACS have TTS, and this number is probably underestimated. Although the prognosis of TTS is generally considered favorable, during the acute phase these patients can develop potentially fatal complications such as ventricular arrhythmias, cardiogenic shock, and heart rupture. Moreover, emerging scientific evidence sheds light on the need to adopt a dedicated diagnostic-therapeutic pathway for this type of patients.
The exact pathophysiology of TTS is still unknown and no large population studies or registries are currently available. Therefore, the purpose of the study is to better characterize the profile of this disease through the creation of a large registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with takotsubo syndrome.
Key inclusion criteria (1 listed)
- Patients diagnosed with TTS in accordance with the InterTAK Diagnostic Criteria.
Key exclusion criteria (4 listed)
- Age less than 18 years
- Myocarditis
- Acute coronary syndrome
- Myocardial infarction with non obstructive coronary arteries (MINOCA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyThe registry will focus on the diagnostic and prognostic value of of echocardiographic features of patients with takotsubo syndrome | Diagnostic test | – |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 1 year
Composite of acute heart failure, takotsubo recurrence and mortality.
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 16 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Takotsubo Syndrome
Active, not recruitingObservational study
The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Recruiting
Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy
Takotsubo Cardiomyopathy
RecruitingObservational study
Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital
Chronic Obstructive Pulmonary Disease, Takotsubo Cardiomyopathy
RecruitingObservational study
Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland
Takotsubo Cardiomyopathy, Myocardial Infarction
RecruitingObservational study
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Takotsubo Syndrome, run by University of Molise.
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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2024.