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Italian Multicenter Observational Registry on Takostubo Syndrome

Takotsubo Italian Network: Italian Multicenter Observational Registry on Takostubo Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06643949
Acronym
TIN
Enrollment
1500
Registered
2024-10-16
Start date
2008-01-01
Completion date
2037-12-31
Last updated
2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takotsubo Syndrome

Keywords

takotsubo, cardiomyopathy, cardiogenic shock, LVOTO, mitral regurgitation, heart failure

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTEchocardiography

The registry will focus on the diagnostic and prognostic value of of echocardiographic features of patients with takotsubo syndrome

Sponsors

University of Molise
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients diagnosed with TTS in accordance with the InterTAK Diagnostic Criteria.

Exclusion criteria

* Age less than 18 years * Myocarditis * Acute coronary syndrome * Myocardial infarction with non obstructive coronary arteries (MINOCA)

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Cardiovascular Events (MACE)1 yearComposite of acute heart failure, takotsubo recurrence and mortality.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026