NCT06643949: TIN

Italian Multicenter Observational Registry on Takostubo Syndrome

Active, enrolled Last updated 16 October 2024

What this trial tests

trial testing Echocardiography in Takotsubo Syndrome in 1,500 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2008

Primary endpoint
31 December 2008

31 December 2037

Quick facts

Lead sponsor	University of Molise
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	1,500
Start date	1 January 2008
Primary completion	31 December 2008
Estimated completion	31 December 2037

Drugs / interventions tested

• Echocardiography

Conditions studied

• Takotsubo Syndrome — all drugs for Takotsubo Syndrome →

Sponsor

University of Molise

Who can join

18 and older, any sex, with Takotsubo Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.