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Takotsubo Syndrome and Air Pollution

NCT05731830 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2024-02-26

No results posted yet for this 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.

Conditions

  • Takotsubo Syndrome

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Rocco A Montone, MD, PhD · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2026-06-30
Completion
2026-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05731830 on ClinicalTrials.gov