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New treatment option for Takotsubo Cardiomyopathy
Official title Characterization of priMary And sEcondary STress Related takOtsubo
ClinicalTrials.gov ID: NCT05793008
What this study is testing
- What it's testing
- 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.
- Time commitment: about 42 months
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 42 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.