Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT03299569
Status:
RECRUITING
Last Update Posted:
2025-03-24
First Post:
2017-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054549', 'term': 'Takotsubo Cardiomyopathy'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '13 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-09-28', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality and morbidity of takotsubo syndrome', 'timeFrame': '13 years', 'description': 'To use a nation-wide cohort (and matched national-wide control populations) to establish the all-cause mortality and consequent all cause hospitalisation rates'}], 'secondaryOutcomes': [{'measure': 'Specific causes of mortality and morbidity of takotsubo syndrome', 'timeFrame': '13 years', 'description': 'To use a nation-wide cohort (and matched national-wide control populations) to establish the specific causes of mortality and morbidities requiring subsequent hospitalisation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Takotsubo Cardiomyopathy', 'Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '18294473', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26332547', 'type': 'BACKGROUND', 'citation': '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, Tschope C, Schultheiss HP, Laney CA, Rajan L, Michels G, Pfister R, Ukena C, Bohm 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, Luscher TF. Clinical Features and Outcomes of Takotsubo (Stress) Cardiomyopathy. N Engl J Med. 2015 Sep 3;373(10):929-38. doi: 10.1056/NEJMoa1406761.'}, {'pmid': '17662398', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23683950', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15703419', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25499134', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22791656', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19468013', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20170799', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23453885', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24768880', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20838396', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '26190982', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20093629', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15547001', 'type': 'BACKGROUND', 'citation': 'Pison L, De Vusser P, Mullens W. Apical ballooning in relatives. Heart. 2004 Dec;90(12):e67. doi: 10.1136/hrt.2004.046813.'}, {'pmid': '19375184', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23561588', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25743177', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nClinical data will be collected for all Takotsubo patients retrospectively and prospectively. This will be compared to two contemporaneous gender and age matched control populations:\n\n1. a cohort of randomly selected individuals from the Scottish general population supplied by Public Health Scotland\n2. patients with myocardial infarction (extracted through collaboration with, the High-STEACS investigators, NCT01852123).\n\nElectronic data linkage will be performed by Public Health Scotland to assess outcomes, prescribing and scores of prediction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with Takotsubo cardiomyopathy in Scotland since 2010', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients diagnosed with Takotsubo cardiomyopathy\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT03299569', 'acronym': 'STARR', 'briefTitle': 'Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland', 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': 'Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland - the STARR Study', 'orgStudyIdInfo': {'id': '16/LO/1059'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Takotsubo cardiomyopathy', 'description': 'All patients diagnosed with Takotsubo cardiomyopathy in Scotland since 2010.'}, {'label': 'Myocardial Infarction', 'description': 'An equal number of myocardial infarction patients in NHS Grampian since 2010.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB25 2ZD', 'city': 'Aberdeen', 'state': 'Scotland', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Amelia Rudd, HND', 'role': 'CONTACT', 'email': 'a.e.rudd@abdn.ac.uk', 'phone': '01224 559573'}], 'facility': 'Cardiac Research Office', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'centralContacts': [{'name': 'Dana Dawson, MD, MRCP', 'role': 'CONTACT', 'email': 'dana.dawson@abdn.ac.uk', 'phone': '01224 437969'}, {'name': 'Amelia Rudd, HND', 'role': 'CONTACT', 'email': 'a.e.rudd@abdn.ac.uk', 'phone': '01224 559573'}], 'overallOfficials': [{'name': 'Dana Dawson, MD, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aberdeen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Tayside', 'class': 'OTHER_GOV'}, {'name': 'NHS Lothian', 'class': 'OTHER_GOV'}, {'name': 'NHS Highlands', 'class': 'OTHER'}, {'name': 'NHS Ayrshire and Arran', 'class': 'OTHER'}, {'name': 'Golden Jubilee National Hospital', 'class': 'OTHER_GOV'}, {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, {'name': 'NHS Lanarkshire', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}