Clinical trial NCT03299569: Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland
Official title: Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland - the STARR Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Takotsubo Cardiomyopathy
Myocardial Infarction
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Tayside
name: NHS Lothian
name: NHS Highlands
name: NHS Ayrshire and Arran
name: Golden Jubilee National Hospital
name: NHS Greater Glasgow and Clyde
name: NHS Lanarkshire
First posted: 2017-10-03
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with Takotsubo cardiomyopathy in Scotland since 2010

Brief summary: Acute stress-induced (Takotsubo cardiomyopathy) presents like a heart attack and is triggered by intense emotional or physical stress. Although coronary arteries are unobstructed, it has been suggested that the risk of death is similar to a myocardial infarction. The purpose of the STARR study is to identify all cases of Takotsubo in Scotland since 2010 and assess its epidemiology and outcomes.

Detailed description: Public Health Scotland will identify all patients centrally coded under codes I42.8 (Other cardiomyopathies), I42.9 (Cardiomyopathy, unspecified) and I51.8 (Other ill-defined heart diseases), using the Community Health Index (CHI) numbers from January 2010. All identified CHI numbers will be thereafter cross-checked with their clinical data at participating health boards to confirm a diagnosis of takotsubo cardiomyopathy and a registry of all confirmed Takotsubo cases will be established.

Clinical data will be collected for all Takotsubo patients retrospectively and prospectively. This will be compared to two contemporaneous gender and age matched control populations:

1. a cohort of randomly selected individuals from the Scottish general population supplied by Public Health Scotland
2. patients with myocardial infarction (extracted through collaboration with, the High-STEACS investigators, NCT01852123).

Electronic data linkage will be performed by Public Health Scotland to assess outcomes, prescribing and scores of prediction.

Eligibility criteria: Inclusion Criteria:

* All patients diagnosed with Takotsubo cardiomyopathy

Exclusion Criteria:

* NA

Primary outcomes:
measure: Mortality and morbidity of takotsubo syndrome
timeFrame: 13 years
Secondary outcomes:
measure: Specific causes of mortality and morbidity of takotsubo syndrome
timeFrame: 13 years
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Cardiac Research Office
state: Scotland
Study officials:
affiliation: University of Aberdeen
name: Dana Dawson, MD, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
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