Actively Recruiting

Age: 18Years +
All Genders
ID05731830

Takotsubo Syndrome and Air Pollution: the Tako-Air Study

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-02-26

250

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Takotsubo syndrome (TTS) is a sudden and reversible heart injury often triggered by intense emotional or physical stress. It mimics a heart attack with symptoms like chest pain, breathing difficulty, and changes on heart tests but occurs without blocked arteries. While once seen as harmless, TTS can cause serious complications and even death during the acute phase. The study explores how air pollution may increase the risk and worsen outcomes of TTS, which is not yet well understood. This observational study will analyze exposure to various air pollutants such as PM10, PM2.5, ozone, nitrogen dioxide, benzene, sulfur dioxide, and carbon monoxide in patients diagnosed with TTS. Researchers will use data from air quality monitors linked to patients' home addresses to assess short-term (daily and weekly) and long-term (annual) pollutant exposure before TTS onset. The study includes patients diagnosed since 2016, with follow-up visits or phone interviews scheduled up to 5 years after hospital discharge to track heart events and TTS recurrence. Participants will provide informed consent and their medical records will supply diagnostic and residential data. Air pollution exposure will be carefully measured and compared for time periods before TTS events using a case-crossover design, where each patient acts as their own control. Outcomes include the relationship between pollutant levels and TTS onset, in-hospital complications, and long-term major cardiovascular events. Data analysis will consider weather and other factors, with clinical follow-up assessments conducted at 6, 12, 24, 36, 48, and 60 months after discharge to monitor health status.

CONDITIONS

Brief Title

Takotsubo Syndrome and Air Pollution

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of Takotsubo syndrome (TTS)
  • Available data on short-term and/or long-term exposure to air pollutants
  • Written informed consent to participate
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • No available data on short-term or long-term exposure to air pollutants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Data Extraction

Duration - 2 years of prior exposure data analyzed

Participants' exposure to air pollution compounds in the two years prior to the occurrence of Takotsubo syndrome (TTS) is analyzed. This includes measuring levels of PM10, PM2.5, O3, NO2, benzene (C6H6), SO2, and CO based on residential addresses and regional air quality monitoring data.

No visits required; data collected from medical records and air quality monitoring databases

Clinical Follow-up

Duration - Up to 60 months

Participants undergo clinical follow-up by telephone interview and/or clinical visit to monitor major adverse cardiovascular events (MACE) and TTS recurrence after hospital discharge.

6 follow-up contacts at 6, 12, 24, 36, 48, and 60 months post-discharge

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

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Research Team

R

Rocco A Montone, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology.

Jelena-Rima Ghadri, Ilan Shor Wittstein, Abhiram Prasad...

https://pubmed.ncbi.nlm.nih.gov/29850871

Assessment of the German and Italian Stress Cardiomyopathy Score for Risk Stratification for In-hospital Complications in Patients With Takotsubo Syndrome.

Francesco Santoro, Iván J Núñez Gil, Thomas Stiermaier...

https://pubmed.ncbi.nlm.nih.gov/31389988

Current state of knowledge on Takotsubo syndrome: a Position Statement from the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology.

Alexander R Lyon, Eduardo Bossone, Birke Schneider...

https://pubmed.ncbi.nlm.nih.gov/26548803

Evolution of cardiac autonomic nervous activity indices in patients presenting with transient left ventricular apical ballooning.

Jasmin Ortak, Kerstin Khattab, Melanie Barantke...

https://pubmed.ncbi.nlm.nih.gov/19250097

Reversible coronary microvascular dysfunction: a common pathogenetic mechanism in Apical Ballooning or Tako-Tsubo Syndrome.

Leonarda Galiuto, Alberto Ranieri De Caterina, Angelo Porfidia...

https://pubmed.ncbi.nlm.nih.gov/20215125