Understanding stress-related heart conditions
Characterization of priMary And sEcondary STress Related takOtsubo: the MAESTRO Pilot Study
This study is trying to understand how stress affects the heart in people with Takotsubo syndrome by looking at brain activity and stress responses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05793008 on ClinicalTrials.gov |
What this trial studies
This study investigates Takotsubo syndrome (TTS), a reversible heart condition often triggered by physical or emotional stress. It aims to explore the underlying mechanisms of TTS by analyzing brain activation and stress responses through neuroimaging and biomarker assessments. Patients diagnosed with TTS will undergo Positron Emission Tomography (PET) analysis, blood sample collection, and clinical follow-up visits to gather comprehensive data on their condition. The research seeks to clarify the relationship between stress and heart function in TTS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Takotsubo syndrome who meet specific diagnostic criteria.
Not a fit: Patients with obstructive coronary artery disease or other heart conditions unrelated to Takotsubo syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of Takotsubo syndrome, potentially reducing complications and enhancing patient outcomes.
How similar studies have performed: Other studies have shown promising results in understanding the link between stress and heart conditions, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Rocco A Montone, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Rocco A Montone, MD, PhD
- Email: roccoantonio.montone@policlinicogemelli.it
- Phone: +39-0630154187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.