Long-term Echocardiographic Findings in Takotsubo Syndrome

NCT05084157 | Unknown DMC

• 1 other identifier: D-21-1111
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Takotsubo syndrome (TTS) is characterized by severe left ventricular (LV) dysfunction that gradually recovers, thus leading to the commonly accepted belief that it is a transient and self-limiting condition. Histologically, TTS can be accompanied by severe morphological alterations potentially resulting from catecholamine excess followed by microcirculatory dysfunction and direct cardiotoxicity. The affected myocardium, however, has a high potential of structural reconstitution which correlates with the rapid functional recovery. The lack of persistent morphological changes in TTS has been confirmed by original CMR studies which pointed out that the acute phase of the disease is characterized only by remarkable myocardial edema with no evidence of significant late gadolinium enhancement. Indeed, the absence of LGE in TTS patients has become a common diagnostic criterion in most CMR centers. Although some studies have challenged this notion by reporting delayed hyper-enhancement in TTS patients, the intensity and extent of LGE in the acute phase of TTS are less than usually reported in studies of myocardial infarction. The long-term clinical and functional consequences of an acute episode of TTS are still unclear. A recent spectroscopic investigation has shown that long-term (\>1 year) abnormalities in cardiac energetic persist after an acute episode of TTS. Also, a few patients with residual wall motion abnormality in whom LGE fails to resolve (suggesting the acute event resulted in frank infarction) have been reported. However, how often persistent morphologic abnormalities are present after the index episode remains undefined. The possibility exists that fibrosis was undetected at follow-up CMR studies using conventional LGE threshold methods due to the fact that myocardial injury is subtler and there are no confidently recognizable reference regions of normal myocardium. Newer echocardiographic tools (i.e. tissue Doppler) have now the potential to detect persistence of post-TTS LV function abnormalities.

Conditions

Takotsubo Cardiomyopathy

Keywords

syndrome

Outcome Measures

Primary Outcomes (1)

• Left ventricular systolic dysfunction

  The time to the echocardiographic finding of left ventricular systolic dysfunction

  Up to 5 years

Interventions

Echocardiography DIAGNOSTIC_TEST

Patients will undergo Doppler echocardiography

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 as having Takotsubo Syndrome on the basis of Mayo Criteria

You may qualify if:

• Diagnosis of TTS according to current International consensus criteria
• Written informed consent
• Age 18 years and over

You may not qualify if:

• Secondary form of TTS (e.g. as it can occur after sepsis, neurological disorders, pheochromocytoma)
• Durg-induced form of TTS (e.g. after administration of drugs such as dopamine, dobutamine, epinephrine, or norepinephrine)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Syndrome

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Carlo Gaudio, MD

  University Sapienza

  STUDY CHAIR

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+39064997; f.pelliccia@mclink.it

Giuseppe Marazzi, MD

CONTACT

+39064997; marazzi.gius@gmail.com

Study Design

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

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 19, 2021
• Study Start: February 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2023
• Last Updated: January 25, 2022

Record last verified: 2022-01