Takotsubo Syndrome and Air Pollution

NCT05731830 | Recruiting

• 1 other identifier: 5290
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Takotsubo Syndrome

Keywords

Air Pollution; Takotsubo Syndrome; Stress cardiomyopathy

Outcome Measures

Primary Outcomes (7)

• 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.

  Up to 30 days

• 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.

  Up to 30 days

• 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.

  Up to 30 days

• 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.

  Up to 30 days

• Association between levels of benzene [C6H6] air pollutant and TTS

  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.

  Up to 30 days

• Association between levels of SO2 air pollutant and TTS

  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.

  Up to 30 days

• Association between levels of CO air pollutant and TTS

  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.

  Up to 30 days

Secondary Outcomes (14)

• Association between levels of PM10 air pollutant and in-hospital complications

  Up to 30 days

• Association between levels of PM2.5 air pollutant and in-hospital complications

  Up to 30 days

• Association between levels of O3 air pollutant and in-hospital complications

  Up to 30 days

• Association between levels of NO2 air pollutant and in-hospital complications

  Up to 30 days

• Association between levels of benzene [C6H6] air pollutant and in-hospital complications

  Up to 30 days

Study Arms (1)

Takotsubo Syndrome

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. Myocarditis will be excluded based on clinical presentation (e.g.: previous flu-like symptoms, increased inflammatory biomarkers) and confirmed by cardiac magnetic resonance. 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).

Other: Data extraction; Other: Clinical follow-up

Interventions

Data extraction OTHER

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.

Takotsubo Syndrome

Clinical follow-up OTHER

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.

Takotsubo Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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).

You may qualify if:

• 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.

You may not qualify if:

• Age \<18 years.
• Not available data for short-term and/or long-term exposure to air pollutants.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Study Officials

• Rocco A Montone, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocco A Montone, MD, PhD

CONTACT

+39-0630154187; roccoantonio.montone@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IRCCS Researcher

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 16, 2023
• Study Start: November 15, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)