Italian Multicenter Observational Registry on Takostubo Syndrome (TIN)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Takotsubo Syndrome
• Intervention / Treatment: Diagnostic test: Echocardiography

• Study Type: Observational
• Enrollment (Actual): 1500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with takotsubo syndrome.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events (MACE)	Composite of acute heart failure, takotsubo recurrence and mortality.	1 year

Collaborators and Investigators

• Sponsor: University of Molise

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): December 31, 2008
• Study Completion (Estimated): December 31, 2037

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: heart failure; cardiogenic shock; mitral regurgitation; cardiomyopathy; takotsubo; LVOTO
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Cardiomyopathies; Ventricular Dysfunction, Left; Ventricular Dysfunction; Syndrome; Takotsubo Cardiomyopathy
• Other Study ID Numbers: 141024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No