Takotsubo Syndrome and Air Pollution

Condition(s) studied

Investigational drug(s) / intervention(s)

Data extraction: The 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: All 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.

Study 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

Primary outcome measure(s)

• Association between levels of PM10 air pollutant and TTS — Up to 30 days
  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.
• Association between levels of PM2.5 air pollutant and TTS — Up to 30 days
  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.
• Association between levels of O3 air pollutant and TTS — Up to 30 days
  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.
• Association between levels of NO2 air pollutant and TTS — Up to 30 days
  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.
• Association between levels of benzene [C6H6] air pollutant and TTS — Up to 30 days
  To assess whether short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutant benzene \[C6H6\], expressed as a concentration in micrograms per cubic meter (µg/m3) could be associated with TTS.
• Association between levels of SO2 air pollutant and TTS — Up to 30 days
  To assess whether short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutants SO2, expressed as a concentration in micrograms per cubic meter (µg/m3) could be associated with TTS.
• Association between levels of CO air pollutant and TTS — Up to 30 days
  To assess whether short-term (daily and weekly) or long-term (annual) exposure to increased levels of air pollutants CO, expressed as a concentration in micrograms per cubic meter (µg/m3) could be associated with TTS.

Trial sites (1)

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