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NCT03299569 Clinical Trial

Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland

Myocardial Infarction Clinical Trial

— STARR  

Official title:
Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland - the STARR Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03299569
Other study ID # 16/LO/1059
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 29, 2016
Est. completion date December 31, 2028

Study information
Verified date December 2023
Source University of Aberdeen
Contact Dana Dawson, MD, MRCP
Phone 01224 437969
Email dana.dawson@doctors.org.uk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 800
Est. completion date December 31, 2028
Est. primary completion date December 31, 2028
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients diagnosed with Takotsubo cardiomyopathy Exclusion Criteria: - NA

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Cardiac Research Office Aberdeen Scotland

Sponsors (8)
Lead Sponsor Collaborator
University of Aberdeen Golden Jubilee National Hospital, NHS Ayrshire and Arran, NHS Greater Glasgow and Clyde, NHS Highlands, NHS Lanarkshire, NHS Lothian, NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

References & Publications (18)

See more »

Outcome
Type Measure Description Time frame Safety issue
Primary Identify number of Takotsubo cases in Scotland Identify number of Takotsubo cases in Scotland 13 years
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