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

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ClinicalTrials.gov Identifier: NCT03299569
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Collaborators:
NHS Tayside
NHS Lothian
NHS Highlands
NHS Ayrshire and Arran
Golden Jubilee National Hospital
NHS Greater Glasgow and Clyde
NHS Lanarkshire
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:
Acute stress-induced (Tako-tsubo) cardiomyopathy presents like a heart attack and is triggered by intense emotional or physical stress. Although heart arteries are unobstructed, the risk of death is similar to a heart attack. The purpose of the STARR study is to identify all cases of Tako-tsubo in Scotland since 2010.

Condition or disease
Takotsubo Cardiomyopathy Myocardial Infarction

Detailed Description:

Each centre put in place two methods of identification of past Tako-tsubo caes:

  • Each local PI received a NSS list containing CHI numbers of all patients coded under Code I42.8, which is for "Other Cardiomyopathies" in the ICD 10 system.
  • Each local PI also enabled a search method in their cardiac catheterisation reporting software in order to identify remaining cases.

The Research Fellow travels to the designated sites to carry out the following work:

  • Cross-check all electronic records of all CHI numbers returned from the NSS to identify only the Tako-tsubo cases from all cases returned under Code I42.8 to each individual local PI.
  • Carry out searches in the cardiac catheterisation software of each hospital to identify the remaining cases.
  • Identify an equal number of MI controls from within the Grampian area.

We will collect clinical data off all Tako-tsubo patients retrospectively and prospectively. The STARR study will benefit from the unique electronic linkage of health records in Scotland.

The STARR study database will be used as a stepping stone to large epidemiology and mechanistic studies.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 13 Years
Official Title: Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland - the STARR Study
Actual Study Start Date : July 29, 2016
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Identify number of Takotsubo cases in Scotland [ Time Frame: 13 years ]
    Identify number of Takotsubo cases in Scotland



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with Takotsubo cardiomyopathy in Scotland since 2010
Criteria

Inclusion Criteria:

  • All patients diagnosed with Takotsubo cardiomyopathy

Exclusion Criteria:

  • NA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299569


Contacts
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Contact: Dana Dawson, MD, MRCP 01224 437969 dana.dawson@doctors.org.uk
Contact: Amelia Rudd, HND 01224 559573 a.e.rudd@abdn.ac.uk

Locations
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United Kingdom
Cardiac Research Office Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZD
Contact: Amelia Rudd, HND    01224 559573    a.e.rudd@abdn.ac.uk   
Sponsors and Collaborators
University of Aberdeen
NHS Tayside
NHS Lothian
NHS Highlands
NHS Ayrshire and Arran
Golden Jubilee National Hospital
NHS Greater Glasgow and Clyde
NHS Lanarkshire
Investigators
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Principal Investigator: Dana Dawson, MD, MRCP University of Aberdeen

Additional Information:

Publications:
Templin C, Ghadri JR, Diekmann J, Napp LC, Bataiosu DR, Jaguszewski M, Cammann VL, Sarcon A, Geyer V, Neumann CA, Seifert B, Hellermann J, Schwyzer M, Eisenhardt K, Jenewein J, Franke J, Katus HA, Burgdorf C, Schunkert H, Moeller C, Thiele H, Bauersachs J, Tschöpe C, Schultheiss HP, Laney CA, Rajan L, Michels G, Pfister R, Ukena C, Böhm M, Erbel R, Cuneo A, Kuck KH, Jacobshagen C, Hasenfuss G, Karakas M, Koenig W, Rottbauer W, Said SM, Braun-Dullaeus RC, Cuculi F, Banning A, Fischer TA, Vasankari T, Airaksinen KE, Fijalkowski M, Rynkiewicz A, Pawlak M, Opolski G, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Crea F, Dichtl W, Franz WM, Empen K, Felix SB, Delmas C, Lairez O, Erne P, Bax JJ, Ford I, Ruschitzka F, Prasad A, Lüscher TF. Clinical Features and Outcomes of Takotsubo (Stress) Cardiomyopathy. N Engl J Med. 2015 Sep 3;373(10):929-38. doi: 10.1056/NEJMoa1406761.
Chen X, Lee G, Maher BS, Fanous AH, Chen J, Zhao Z, Guo A, van den Oord E, Sullivan PF, Shi J, Levinson DF, Gejman PV, Sanders A, Duan J, Owen MJ, Craddock NJ, O'Donovan MC, Blackman J, Lewis D, Kirov GK, Qin W, Schwab S, Wildenauer D, Chowdari K, Nimgaonkar V, Straub RE, Weinberger DR, O'Neill FA, Walsh D, Bronstein M, Darvasi A, Lencz T, Malhotra AK, Rujescu D, Giegling I, Werge T, Hansen T, Ingason A, Nöethen MM, Rietschel M, Cichon S, Djurovic S, Andreassen OA, Cantor RM, Ophoff R, Corvin A, Morris DW, Gill M, Pato CN, Pato MT, Macedo A, Gurling HM, McQuillin A, Pimm J, Hultman C, Lichtenstein P, Sklar P, Purcell SM, Scolnick E, St Clair D, Blackwood DH, Kendler KS; GROUP investigators; International Schizophrenia Consortium. GWA study data mining and independent replication identify cardiomyopathy-associated 5 (CMYA5) as a risk gene for schizophrenia. Mol Psychiatry. 2011 Nov;16(11):1117-29. doi: 10.1038/mp.2010.96. Epub 2010 Sep 14.

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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03299569     History of Changes
Other Study ID Numbers: 16/LO/1059
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Takotsubo Cardiomyopathy
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction