Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05793008

Characterization of priMary And sEcondary STress Related takOtsubo

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-02-26

60

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Takotsubo syndrome (TTS) is an acute and reversible form of myocardial injury often preceded by a physical or emotional trigger. Although TTS was generally considered a benign disease for its reversible nature, it is now clear that hemodynamic and electrical instability during the acute phase exposes patients to frequent serious adverse in-hospital complications. However, the pathophysiology of TTS is far from being completely understood. Consistent evidence demonstrated that the environmental events experienced by most of these patients and perceived as stressful (both physical or emotional) induce a brain activation and a stress-related response, with increasing bioavailability of local and circulating stress mediators, such as catecholamine and cortisol, which showed to play a major role in the etiology of to the "neurogenic stunning myocardium" responsible for this clinical condition. Primary and secondary TTS showed an important clinical heterogeneity identifying two different subtypes of patients with different outcomes and risk profiles. the invastigators hypothesize that a different activation of the brain structures involved in acute stress response, as well as a different exposure to chronic stress, may subtend the different clinical and risk profiles observed in primary vs. secondary TTS patients. Moreover, the invastigators hypothesize that distinct signatures of circulating biomarkers may be associated with these two categories of TTS patients. Therefore, identifying these specific signatures may help in the diagnosis of these patients and pave the way for the identification of specific pathophysiologic pathways and the development of future therapies.

CONDITIONS

Official Title

Characterization of priMary And sEcondary STress Related takOtsubo

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent by the patient or legal representative
  • Takotsubo syndrome diagnosed by modified Mayo Clinic Diagnostic Criteria including transient left ventricular wall motion abnormality beyond single coronary artery, no obstructive coronary artery disease, new ECG changes or troponin elevation, and absence of pheochromocytoma or myocarditis
  • Diagnosis of sepsis defined as life-threatening organ dysfunction with SOFA score increase of 2 or more
  • Septic shock defined by vasopressor need to maintain mean arterial pressure ≥65 mmHg and serum lactate >2 mmol/L without hypovolemia
  • Sepsis-induced cardiomyopathy defined as left ventricular systolic and/or diastolic dysfunction after sepsis without prior cardiac disease
Not Eligible

You will not qualify if you...

  • Alternate diagnosis explaining the clinical presentation
  • Contraindication to PET scan for TTS patients such as pregnancy, breastfeeding, or planned pregnancy during study
  • Comorbidities with expected survival less than 1 year

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

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Research Team

R

Rocco A Montone, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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