Characterization of priMary And sEcondary STress Related takOtsubo

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a condition called Takotsubo syndrome (TTS), which is a type of heart injury that can occur suddenly, often triggered by stress, whether emotional or physical. Researchers want to better understand the differences between two types of TTS: primary TTS, which mostly affects post-menopausal women due to emotional stress, and secondary TTS, which can affect both men and women and is usually linked to physical stress like infections. By exploring how these different types of TTS react in the body and what specific markers are present, the study aims to improve diagnosis and treatment options for patients.

To participate in this trial, individuals must be diagnosed with either TTS or sepsis-related heart issues and give their consent. Key eligibility criteria include having a confirmed diagnosis of TTS based on specific medical guidelines, or having sepsis with heart dysfunction without other known heart problems. Participants can expect to undergo various assessments to help researchers gather information about how their condition affects their heart and overall health. It's important to note that those with certain health conditions or who cannot undergo specific tests will not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• For patients with TTS:
• • Informed consent signed by the patient or parent/guardian/legal representative.
• • TTS diagnosed based on modified Mayo Clinic Diagnostic Criteria as: (i) transient wall motion abnormality in the left ventricle beyond a single epicardial coronary artery distribution; (ii) absence of obstructive coronary artery disease or angiographic evidence of acute plaque rupture, which can explain the wall motion abnormality; (iii) new electrocardiographic abnormalities or elevation in cardiac troponin values; (iv) absence of pheochromocytoma or myocarditis. N.B. - All TTS diagnosis made according to Mayo Clinic Diagnostic Criteria will be a posterior compared to fulfil the new InterTAK Diagnostic Criteria (19). Myocarditis will be suspected based on clinical presentation (e.g. previous flu-like symptoms, increased inflammatory biomarkers) and confirmed by cardiac magnetic resonance.N.B. - Of note, primary TTS mainly concerns post-menopausal women with symptoms resulting from myocardial damage, emotional trigger, and evidence of normal coronary arteries at coronary angiography, whilst secondary TTS equally affects men and women, with physical triggers and in the presence of possible coronary artery disease at coronary angiography.
• For patients with sepsis:
• • Informed consent signed by the patient or parent/guardian/legal representative.
• • Diagnosis of sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection, which can be represented by an increase in the Sequential \[Sepsis-related\] Organ Failure Assessment (SOFA) score of 2 points or more.
• • Septic a shock, defined as vasopressor requirement to maintain a mean arterial pressure of 65 mmHg or greater and serum lactate level greater than 2 mmol/L (\>18 mg/dL) in the absence of hypovolemia.
• • Sepsis-induced cardiomyopathy, defined as left ventricular systolic dysfunction (LVSD) and/or LV diastolic dysfunction (LVDD) following sepsis in patients without known structural or functional cardiac disease.
• Exclusion Criteria:
• • Alternate diagnosis for the clinical presentation.
• • Contraindication to PET for patients with TTS (pregnancy, breast-feeding or patients considering becoming pregnant during the study period);
• • Patients with comorbidities having an expected survival \<1-year.