Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland

NCT ID: NCT03299569

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-29

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Takotsubo Cardiomyopathy Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Takotsubo cardiomyopathy

All patients diagnosed with Takotsubo cardiomyopathy in Scotland since 2010.

No interventions assigned to this group

Myocardial Infarction

An equal number of myocardial infarction patients in NHS Grampian since 2010.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients diagnosed with Takotsubo cardiomyopathy

Exclusion Criteria

* NA
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Tayside

OTHER_GOV

Sponsor Role collaborator

NHS Lothian

OTHER_GOV

Sponsor Role collaborator

NHS Highlands

OTHER

Sponsor Role collaborator

NHS Ayrshire and Arran

OTHER

Sponsor Role collaborator

Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role collaborator

NHS Lanarkshire

OTHER_GOV

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dana Dawson, MD, MRCP

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

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Cardiac Research Office

Aberdeen, Scotland, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dana Dawson, MD, MRCP

Role: CONTACT

01224 437969

Amelia Rudd, HND

Role: CONTACT

01224 559573

Facility Contacts

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Amelia Rudd, HND

Role: primary

01224 559573

References

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Prasad A, Lerman A, Rihal CS. Apical ballooning syndrome (Tako-Tsubo or stress cardiomyopathy): a mimic of acute myocardial infarction. Am Heart J. 2008 Mar;155(3):408-17. doi: 10.1016/j.ahj.2007.11.008. Epub 2008 Jan 31.

Reference Type BACKGROUND
PMID: 18294473 (View on PubMed)

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Reference Type BACKGROUND
PMID: 26332547 (View on PubMed)

Elesber AA, Prasad A, Lennon RJ, Wright RS, Lerman A, Rihal CS. Four-year recurrence rate and prognosis of the apical ballooning syndrome. J Am Coll Cardiol. 2007 Jul 31;50(5):448-52. doi: 10.1016/j.jacc.2007.03.050. Epub 2007 Jul 16.

Reference Type BACKGROUND
PMID: 17662398 (View on PubMed)

Sy F, Basraon J, Zheng H, Singh M, Richina J, Ambrose JA. Frequency of Takotsubo cardiomyopathy in postmenopausal women presenting with an acute coronary syndrome. Am J Cardiol. 2013 Aug 15;112(4):479-82. doi: 10.1016/j.amjcard.2013.04.010. Epub 2013 May 16.

Reference Type BACKGROUND
PMID: 23683950 (View on PubMed)

Wittstein IS, Thiemann DR, Lima JA, Baughman KL, Schulman SP, Gerstenblith G, Wu KC, Rade JJ, Bivalacqua TJ, Champion HC. Neurohumoral features of myocardial stunning due to sudden emotional stress. N Engl J Med. 2005 Feb 10;352(6):539-48. doi: 10.1056/NEJMoa043046.

Reference Type BACKGROUND
PMID: 15703419 (View on PubMed)

Dawson DK, Neil CJ, Henning A, Cameron D, Jagpal B, Bruce M, Horowitz J, Frenneaux MP. Tako-Tsubo Cardiomyopathy: A Heart Stressed Out of Energy? JACC Cardiovasc Imaging. 2015 Aug;8(8):985-7. doi: 10.1016/j.jcmg.2014.10.004. Epub 2014 Nov 1. No abstract available.

Reference Type BACKGROUND
PMID: 25499134 (View on PubMed)

Neil C, Nguyen TH, Kucia A, Crouch B, Sverdlov A, Chirkov Y, Mahadavan G, Selvanayagam J, Dawson D, Beltrame J, Zeitz C, Unger S, Redpath T, Frenneaux M, Horowitz J. Slowly resolving global myocardial inflammation/oedema in Tako-Tsubo cardiomyopathy: evidence from T2-weighted cardiac MRI. Heart. 2012 Sep;98(17):1278-84. doi: 10.1136/heartjnl-2011-301481. Epub 2012 Jul 11.

Reference Type BACKGROUND
PMID: 22791656 (View on PubMed)

Madhavan M, Borlaug BA, Lerman A, Rihal CS, Prasad A. Stress hormone and circulating biomarker profile of apical ballooning syndrome (Takotsubo cardiomyopathy): insights into the clinical significance of B-type natriuretic peptide and troponin levels. Heart. 2009 Sep;95(17):1436-41. doi: 10.1136/hrt.2009.170399. Epub 2009 May 24.

Reference Type BACKGROUND
PMID: 19468013 (View on PubMed)

Summers MR, Lennon RJ, Prasad A. Pre-morbid psychiatric and cardiovascular diseases in apical ballooning syndrome (tako-tsubo/stress-induced cardiomyopathy): potential pre-disposing factors? J Am Coll Cardiol. 2010 Feb 16;55(7):700-1. doi: 10.1016/j.jacc.2009.10.031. No abstract available.

Reference Type BACKGROUND
PMID: 20170799 (View on PubMed)

Cross-Disorder Group of the Psychiatric Genomics Consortium. Identification of risk loci with shared effects on five major psychiatric disorders: a genome-wide analysis. Lancet. 2013 Apr 20;381(9875):1371-1379. doi: 10.1016/S0140-6736(12)62129-1. Epub 2013 Feb 28.

Reference Type BACKGROUND
PMID: 23453885 (View on PubMed)

Arbustini E, Narula N, Dec GW, Reddy KS, Greenberg B, Kushwaha S, Marwick T, Pinney S, Bellazzi R, Favalli V, Kramer C, Roberts R, Zoghbi WA, Bonow R, Tavazzi L, Fuster V, Narula J. Reply: The MOGE(S) classification for a phenotype-genotype nomenclature of cardiomyopathy: more questions than answers? J Am Coll Cardiol. 2014 Jun 17;63(23):2584-2586. doi: 10.1016/j.jacc.2014.03.028. Epub 2014 Apr 23. No abstract available.

Reference Type BACKGROUND
PMID: 24768880 (View on PubMed)

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, Noethen 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.

Reference Type BACKGROUND
PMID: 20838396 (View on PubMed)

Ashbrook DG, Williams RW, Lu L, Hager R. A cross-species genetic analysis identifies candidate genes for mouse anxiety and human bipolar disorder. Front Behav Neurosci. 2015 Jul 1;9:171. doi: 10.3389/fnbeh.2015.00171. eCollection 2015.

Reference Type BACKGROUND
PMID: 26190982 (View on PubMed)

McCalmon SA, Desjardins DM, Ahmad S, Davidoff KS, Snyder CM, Sato K, Ohashi K, Kielbasa OM, Mathew M, Ewen EP, Walsh K, Gavras H, Naya FJ. Modulation of angiotensin II-mediated cardiac remodeling by the MEF2A target gene Xirp2. Circ Res. 2010 Mar 19;106(5):952-60. doi: 10.1161/CIRCRESAHA.109.209007. Epub 2010 Jan 21.

Reference Type BACKGROUND
PMID: 20093629 (View on PubMed)

Pison L, De Vusser P, Mullens W. Apical ballooning in relatives. Heart. 2004 Dec;90(12):e67. doi: 10.1136/hrt.2004.046813.

Reference Type BACKGROUND
PMID: 15547001 (View on PubMed)

Kumar G, Holmes DR Jr, Prasad A. "Familial" apical ballooning syndrome (Takotsubo cardiomyopathy). Int J Cardiol. 2010 Oct 29;144(3):444-5. doi: 10.1016/j.ijcard.2009.03.078. Epub 2009 Apr 17.

Reference Type BACKGROUND
PMID: 19375184 (View on PubMed)

Sharkey SW, Lips DL, Pink VR, Maron BJ. Daughter-mother tako-tsubo cardiomyopathy. Am J Cardiol. 2013 Jul 1;112(1):137-8. doi: 10.1016/j.amjcard.2013.02.063. Epub 2013 Apr 2.

Reference Type BACKGROUND
PMID: 23561588 (View on PubMed)

Caretta G, Robba D, Vizzardi E, Bonadei I, Raddino R, Metra M. Tako-tsubo cardiomyopathy in two sisters: a chance finding or familial predisposition? Clin Res Cardiol. 2015 Jul;104(7):614-6. doi: 10.1007/s00392-015-0837-0. Epub 2015 Mar 6. No abstract available.

Reference Type BACKGROUND
PMID: 25743177 (View on PubMed)

Other Identifiers

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16/LO/1059

Identifier Type: -

Identifier Source: org_study_id

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