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Is There a Genetic Predisposition for Acute Stress-induced (Takotsubo) Cardiomyopathy (GENETIC)

Primary Purpose

Takotsubo Cardiomyopathy

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Blood collection for genetic analysis
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Takotsubo Cardiomyopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients who have been diagnosed with Takotsubo cardiomyopathy in Scotland between 2010 to date.
  • Familial cases elsewhere in the world who would be willing to participate.

Exclusion Criteria:

  • Unwillingness to participate

Sites / Locations

  • Cardiovascular Research FacilityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Takotsubo Case Arm

Arm Description

A patient that has been diagnosed with Takotsubo Cardiomyopathy from 2010 onwards.

Outcomes

Primary Outcome Measures

Genome Wide Association Study
Genome Wide Association Study to search for susceptibility variants

Secondary Outcome Measures

Full Information

First Posted
August 3, 2020
Last Updated
September 29, 2021
Sponsor
University of Aberdeen
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1. Study Identification

Unique Protocol Identification Number
NCT04513054
Brief Title
Is There a Genetic Predisposition for Acute Stress-induced (Takotsubo) Cardiomyopathy
Acronym
GENETIC
Official Title
Is There a Genetic Predisposition for Acute Stress-induced (Takotsubo) Cardiomyopathy: The GENETIC Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute stress-induced (takotsubo) cardiomyopathy or broken heart syndrome presents like a heart attack, classically is triggered by intense emotional or physical stress and can have serious health consequences. In the current study the investigators wish to establish whether there is a genetic predisposition making certain people more susceptible to this condition. This could also have implications for their families.
Detailed Description
Acute stress-induced (takotsubo) cardiomyopathy presents like a myocardial infarct, is triggered by intense emotional or physical stress, and can have catastrophic and potentially fatal consequences. Despite data linking takotsubo cardiomyopathy with conditions that have a recognized genetic predisposition (such as mental health and neurological problems), a systematic and comprehensive characterisation of the genetic-epidemiologic factors in takotsubo is lacking. The researchers propose to further investigate this disorder by collecting blood from probands and characterising the genotype of patients with takotsubo cardiomyopathy in a large scale, nationwide genome wide association study. The investigators will also archive DNA for identification of future candidate genetic variants. Ultimately, understanding the underlying predisposition of this poorly understood neuro-psycho-cardiac disorder is essential if we are to move this field forward.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takotsubo Cardiomyopathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group observational study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Takotsubo Case Arm
Arm Type
Other
Arm Description
A patient that has been diagnosed with Takotsubo Cardiomyopathy from 2010 onwards.
Intervention Type
Genetic
Intervention Name(s)
Blood collection for genetic analysis
Intervention Description
Blood collection for genetic analysis
Primary Outcome Measure Information:
Title
Genome Wide Association Study
Description
Genome Wide Association Study to search for susceptibility variants
Time Frame
At baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients who have been diagnosed with Takotsubo cardiomyopathy in Scotland between 2010 to date. Familial cases elsewhere in the world who would be willing to participate. Exclusion Criteria: Unwillingness to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amelia E Rudd, MSc
Phone
01224559473
Ext
01224559473
Email
a.e.rudd@abdn.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana K Dawson, MD, MPhil
Organizational Affiliation
University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Research Facility
City
Aberdeen
State/Province
Aberdeenshire
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amelia Rudd, MSc
Phone
01224559473
Ext
01224559473
Email
a.e.rudd@abdn.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Is There a Genetic Predisposition for Acute Stress-induced (Takotsubo) Cardiomyopathy

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