Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05793008

Characterization of Primary and Secondary Stress-Related Takotsubo Syndrome: the MAESTRO Pilot Study

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

60

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying Takotsubo syndrome (TTS), an acute and reversible heart injury often triggered by physical or emotional stress. This condition can lead to serious complications despite its reversible nature. The study focuses on understanding differences between primary and secondary TTS, including how brain stress response and chronic stress exposure contribute to these subtypes. It also aims to explore distinct circulating biomarker patterns and their links to clinical outcomes in TTS and sepsis-related heart conditions. The study involves diagnostic tests like Positron Emission Tomography (PET) to analyze brain activity related to stress response in TTS patients. Blood and hair samples will be collected to measure stress hormones and inflammatory markers both during the acute phase and at a 3-month follow-up. Participants include those diagnosed with primary or secondary TTS and patients with sepsis or sepsis-induced cardiomyopathy. PET scans will focus on brain areas involved in stress regulation, such as the limbic system and neocortex. Participants will undergo blood sampling at specified times, hair collection for cortisol analysis, and a PET scan three months after the acute event. Follow-up visits will assess changes in biomarkers and brain activity related to stress. The main outcome measured is the association between brain activation and clinical features of TTS at three months. Secondary outcomes include links between hair cortisol levels, inflammatory markers, and TTS or sepsis-related heart dysfunction. The total study duration is about 42 months with enrollment, follow-up, and data analysis phases.

CONDITIONS

Brief 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.
  • Diagnosis of Takotsubo Syndrome based on modified Mayo Clinic Diagnostic Criteria, including transient left ventricular wall motion abnormality, absence of obstructive coronary artery disease, new ECG abnormalities or elevated cardiac troponin, and exclusion of pheochromocytoma or myocarditis.
  • Diagnosis of sepsis defined by life-threatening organ dysfunction with SOFA score increase of 2 or more.
  • Diagnosis of septic shock requiring vasopressors to maintain mean arterial pressure ≥65 mmHg and serum lactate >2 mmol/L without hypovolemia.
  • Diagnosis of sepsis-induced cardiomyopathy with left ventricular systolic and/or diastolic dysfunction following sepsis without known cardiac disease.
  • Age 18 years or older.
Not Eligible

You will not qualify if you...

  • Alternate diagnosis explaining clinical presentation.
  • Contraindications to PET scan such as pregnancy, breastfeeding, or planning pregnancy during the study.
  • Comorbidities with expected survival less than 1 year.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within first 48 hours after enrollment

Participants undergo blood sample collection and hair sampling for cortisol assay to assess biochemical and stress-related markers. This occurs at the time of coronary angiography for Takotsubo Syndrome patients or within the first 48 hours for patients with sepsis or septic shock.

1 visit (in-person)

Follow-up Assessment

Duration - At 3 months (90 ± 5 days) after enrollment

Participants with primary or secondary Takotsubo Syndrome have a follow-up visit approximately 3 months after enrollment for Positron Emission Tomography (PET) brain imaging and additional blood sample collection to assess brain stress response and circulating biomarkers.

1 visit (in-person)

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

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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Published Research Related To This Trial

Assessment of the German and Italian Stress Cardiomyopathy Score for Risk Stratification for In-hospital Complications in Patients With Takotsubo Syndrome.

Francesco Santoro, Iván J Núñez Gil, Thomas Stiermaier...

https://pubmed.ncbi.nlm.nih.gov/31389988

Stress-associated neurobiological activity associates with the risk for and timing of subsequent Takotsubo syndrome.

Azar Radfar, Shady Abohashem, Michael T Osborne...

https://pubmed.ncbi.nlm.nih.gov/33768230