| NCT ID | NCT05731830 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Takotsubo Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-11-15 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2022-11-15 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Takotsubo syndrome (TTS) is an acute and reversible form of myocardial injury characterized by typical regional wall motion abnormalities in the absence of culprit epicardial coronary artery disease frequently precipitated by significant emotional stress or serious physical illness. The clinical presentation is usually similar to acute myocardial infarction (MI), with chest pain and/or dyspnea, ST-segment elevation or depression and/or T-wave inversion on the resting electrocardiogram (ECG) and elevation of serum cardiac troponin. Although previously considered a benign disease, it is now clear that TTS is associated with severe acute complications during the acute phase including hemodynamic and electrical instability and up to 5% of in-hospital mortality. The pathogenetic mechanisms of air pollution are likely to predispose to the occurrence as well as to mediate a worse clinical presentation and outcome of TTS, proving air pollution as a TTS risk factor.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years. * Diagnosis of TTS. * Available data for short-term and/or long-term exposure to air pollutants (see below). * Written informed consent to participate. Exclusion Criteria: * Age \<18 years. * Not available data for short-term and/or long-term exposure to air pollutants.
Contact & Investigator
Rocco A Montone, MD, PhD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT05731830 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Takotsubo Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05731830 currently recruiting?
Yes, NCT05731830 is actively recruiting participants. Contact the research team at roccoantonio.montone@policlinicogemelli.it for enrollment information.
Where is the NCT05731830 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05731830 clinical trial?
NCT05731830 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Rocco A Montone, MD, PhD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 250 participants.