Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland (STARR)

December 7, 2023 updated by: University of Aberdeen

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZD
        • Recruiting
        • Cardiac Research Office
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients diagnosed with Takotsubo cardiomyopathy in Scotland since 2010

Description

Inclusion Criteria:

  • All patients diagnosed with Takotsubo cardiomyopathy

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Takotsubo cardiomyopathy
All patients diagnosed with Takotsubo cardiomyopathy in Scotland since 2010.
Myocardial Infarction
An equal number of myocardial infarction patients in NHS Grampian since 2010.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify number of Takotsubo cases in Scotland
Time Frame: 13 years
Identify number of Takotsubo cases in Scotland
13 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

NHS Lothian
NHS Tayside
NHS Greater Glasgow and Clyde
NHS Lanarkshire
NHS Ayrshire and Arran
Golden Jubilee National Hospital
NHS Highlands

Investigators

  • Principal Investigator: Dana Dawson, MD, MRCP, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2016

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

September 28, 2017

First Posted (Actual)

October 3, 2017

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/LO/1059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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