Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643949
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Italian Multicenter Observational Registry on Takostubo Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Takotsubo Italian Network Italian Multicenter Observational Registry on Takostubo Syndrome
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIN
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 25 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
It is estimated that more than 25 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None