Italian Multicenter Observational Registry on Takostubo Syndrome

NCT ID: NCT06643949

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-01
• Study Completion Date: 2037-12-31

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.

Conditions

Takotsubo Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Echocardiography

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Molise

OTHER

Sponsor Role: lead

Responsible Party

Rodolfo Citro

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

141024

Identifier Type: -

Identifier Source: org_study_id