Italian Multicenter Observational Registry on Takostubo Syndrome

NCT06643949 | Active Not Recruiting DMC

• 1 other identifier: 141024
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

  Composite of acute heart failure, takotsubo recurrence and mortality.

  1 year

Interventions

Echocardiography DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with takotsubo syndrome.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Molise: lead

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Cardiomyopathies; Shock, Cardiogenic; Mitral Valve Insufficiency; Heart Failure

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: January 1, 2008
• Primary Completion: December 31, 2008
• Study Completion (Estimated): December 31, 2037
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share