Characterization of priMary And sEcondary STress Related takOtsubo

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 30, 2023

Primary Completion Date

March 2, 2026

Study Completion Date

September 2, 2026

Conditions
Takotsubo CardiomyopathySepsis-induced Cardiomyopathy
Interventions
DIAGNOSTIC_TEST

Positron Emission Tomography (PET) analysis

18F-FDG-PET/CT imaging will be performed 3 months after the acute event at the Department of Nuclear Medicine of Fondazione Policlinico Universitario A. Gemelli IRCCS using an integrated scanner. Intravenous 18F-FDG (370 MBq) will be given following an overnight fast. Three-dimensional PET imaging will be performed after 1 h of quiet waiting. A non-gated, non-contrast CT will be acquired for attenuation correction. Brain structures analyzed will include the neocortex, limbic system (insula, amygdala, cingulate cortex, and hippocampus), reticular formation, brainstem, and spinal cord.

DIAGNOSTIC_TEST

Blood samples collection

"At the time of coronary angiography for patients with primary or secondary TTS and within the first 48 hours for patients with sepsis or septic shock, arterial blood samples will be collected in 1 Vacuette® 9 mL CAT Serum Clot Activator tube and 4 Vacuette® 6 mL EDTA tubes. Furthermore, a hair sample of 6 cm will be collected for hair cortisol assay.~For patients with primary or secondary TTS blood samples will be collected by venipuncture with 1 Vacuette® 9 mL CAT Serum Clot Activator tube and 4 Vacuette® 6 mL EDTA tubes also at 3 months follow-up.~Blood samples will be immediately centrifuged to obtain whole blood, serum, and plasma samples, and then aliquoted into Eppendorf-type tubes. All samples will then be stored at -80°C until the analysis."

OTHER

Clinical follow up visit

Participation in this study requires for patients with primary vs secondary TTS, a follow-up visit at 3 months (90 +/- 5 gg) after enrollment to assess a Positron Emission Tomography (PET) analysis, and during the same visit, venous blood sampling as described above will be further performed.

Trial Locations (1)

00168

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER