Takotsubo Syndrome and Air Pollution
ConditionTakotsubo Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age <18 years.
Not available data for short-term and/or long-term exposure to air pollutants.
Trial population
We will enroll all patients admitted to the Department of Cardiovascular Sciences of Fondazione Policlinico Universitario A. Gemelli IRCCS with a diagnosis of TTS. TTS will be diagnosed based on the most recent InterTAK Diagnostic Criteria (31). Myocarditis will be excluded based on clinical presentation (e.g.: previous flu-like symptoms, increased inflammatory biomarkers) and confirmed by cardiac magnetic resonance. All prospectively enrolled patients will provide written informed consent to participate. We will further include all patients with a confirmed TTS diagnosis made between January 2016 and end of October 2022 (hypothetical beginning of prospective phase).
Trial design
Design model
Case-crossover
Time perspective
Other
Treatments tested in this trial
Data extraction
Other interventionThe exposure of patients to air pollution compounds in the two years prior to the occurrence of TTS will be analysed. We will investigate: PM10, PM2.5, O3, NO2, C6H6, SO2 e CO. Residential addresses will be obtained from medical records. Annual average 24-h of pollutants levels will be measured matching each individual's home address, and the "ArpaLazio" website (http://www.arpalazio.net/main/aria/sci/basedati/chimici/chimici.php), which provides the concentration of NO, NO2, NOx, PM10, PM2.5, O3, CO, C6H6, SO2 expressed in micrograms per cubic meter (µg/m3). Hourly data are available for all gaseous pollutants, while the levels of PM10 and PM2.5 are expressed daily. Data will be obtained from the air quality monitor closest to each participant's residence that was active for the entire year, and short-term (daily and weekly) and long-term (annual) air pollution exposure will be quantified as daily, weekly, and annual average 24-h pollutants level of measurements before TTS.
Clinical follow-up
Other interventionAll patients will undergo a clinical follow-up by telephonic interview and/or clinical visit at 6, 12, 24, 36, 48 and 60 months from hospital discharge, during which the incidence of MACE, defined as the composite of all-cause mortality, non-fatal MI, transient ischemic attack (TIA)/stroke, and hospitalization for heart failure, and the recurrence of TTA in the past months will be investigated and collected.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Takotsubo Syndrome2 interventions
Trial outcomes
Primary outcomes
1
Association between levels of PM10 air pollutant and TTS
To assess whether short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutant PM10, expressed as a concentration in micrograms per cubic meter (µg/m3) could be associated with TTS.
Time frame
Up to 30 days2
Association between levels of PM2.5 air pollutant and TTS
To assess whether short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutant PM2.5, expressed as a concentration in micrograms per cubic meter (µg/m3) could be associated with TTS.
Time frame
Up to 30 days3
Association between levels of O3 air pollutant and TTS
To evaluate whether short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutants O3, expressed as concentration in micrograms per cubic meter (µg/m3), could be associated with TTS.
Time frame
Up to 30 days4
Association between levels of NO2 air pollutant and TTS
To assess whether short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutants NO2, expressed as a concentration in micrograms per cubic meter (µg/m3) could be associated with TTS.
Time frame
Up to 30 daysSecondary outcomes
1
Association between levels of PM10 air pollutant and in-hospital complications
To assess whether a short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutant PM10 could be associated with a higher rate of in-hospital complications (defined as the necessity of inotropic drugs, necessity of temporary ventricular support, necessity of mechanical ventilation, ventricular arrhythmias, new-onset FA, stroke/TIA, in-hospital death) in patients with TTS.
Time frame
Up to 30 days2
Association between levels of PM2.5 air pollutant and in-hospital complications
To assess whether a short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutant PM2.5 could be associated with a higher rate of in-hospital complications (defined as the necessity of inotropic drugs, necessity of temporary ventricular support, necessity of mechanical ventilation, ventricular arrhythmias, new-onset FA, stroke/TIA, in-hospital death) in patients with TTS.
Time frame
Up to 30 days3
Association between levels of O3 air pollutant and in-hospital complications
To assess whether a short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutant O3 could be associated with a higher rate of in-hospital complications (defined as the necessity of inotropic drugs, necessity of temporary ventricular support, necessity of mechanical ventilation, ventricular arrhythmias, new-onset FA, stroke/TIA, in-hospital death) in patients with TTS.
Time frame
Up to 30 days4
Association between levels of NO2 air pollutant and in-hospital complications
To assess whether a short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutant NO2 could be associated with a higher rate of in-hospital complications (defined as the necessity of inotropic drugs, necessity of temporary ventricular support, necessity of mechanical ventilation, ventricular arrhythmias, new-onset FA, stroke/TIA, in-hospital death) in patients with TTS.
Time frame
Up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov