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/29850871Actively Recruiting
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-02-26
250
Participants Needed
1
Research Sites
21 weeks
Total Duration
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
Takotsubo Syndrome and Air Pollution
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
R
Rocco A Montone, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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