Influenzavaccine for at forhindre uønskede vaskulære hændelser: Pilot (IVVE:Pilot)
25. oktober 2018 opdateret af: McMaster University
Et randomiseret kontrolleret forsøg med influenzavaccine for at forhindre uønskede vaskulære hændelser: en pilotundersøgelse
Et multicenter, randomiseret, placebokontrolleret forsøg.
Deltagere med høj risiko for vaskulære hændelser fra INTERCHF's netværk vil blive randomiseret til inaktiveret influenzavaccine eller placebo og følges prospektivt over tre influenzasæsoner.
600 deltagere vil blive tilmeldt før influenzasæsonen og randomiseret til enten influenzavaccine eller saltvandsplacebo.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Hjerte-kar-sygdomme er en væsentlig årsag til sygelighed og dødelighed.
Der er nyere beviser for, at infektion på grund af influenza kan fremkalde vaskulære hændelser såsom myokardieinfarkter og slagtilfælde.
Der er nogle beviser for, at influenzavaccination kan forhindre sådanne hændelser, men dataene er usikre.
Efterforskerne foreslår et randomiseret kontrolleret forsøg for at vurdere, om influenzavaccination vil forhindre vaskulær sygdom.
Voksne med klinisk hjertesvigt vil blive randomiseret til inaktiveret influenzavaccine eller placebo med saltvand.
Denne pilotundersøgelse vil give nødvendige data til at fastslå gennemførligheden af en større undersøgelse.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
107
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Emita
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Manila, Emita, Filippinerne
- University of Philippines
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Maputo, Mozambique
- Maputo Central Hospital
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Kampala, Uganda
- Mulago Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Alder ≥ 18 år og NYHA funktionsklasse II, III og IV
Ekskluderingskriterier:
- Anafylaktisk reaktion på en tidligere dosis TIV
- Kendt IgE-medieret overfølsomhed over for æg manifesteret som nældefeber, hævelse af mund og svælg, vejrtrækningsbesvær, hypotension eller chok
- Guillain-Barrés syndrom inden for otte uger efter en tidligere influenzavaccine
- Anafylaktisk reaktion på neomycin
- Patienter, der har fået influenzavaccine i to af de tre foregående år
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: influenzavaccine
Deltagere med høj risiko for uønskede vaskulære hændelser vil blive immuniseret med 0,5 ml dosis inaktiveret trivalent influenzavaccine
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0,5 ml dosis injiceres intramuskulært
Andre navne:
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Placebo komparator: placebo vaccination
Deltagere med høj risiko for uønskede vaskulære hændelser vil blive immuniseret med en dosis på 0,5 ml sterilt saltvand inaktiveret i influenzasæsonen.
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0,5 ml dosis injiceres intramuskulært
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Gennemførlighed
Tidsramme: Seks måneder
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Hvis ikke mere end 5 % af alle rekrutterede forsøgspersoner krydser over fra den ene undersøgelsesgruppe til den anden, og hvis der er mindst 98 % opfølgning.
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Seks måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Uønsket kardiovaskulær hændelse
Tidsramme: Seks måneder
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Det primære resultat vil være en sammensætning af kardiovaskulær død, ikke-dødelig myokardieinfarkt, ikke-dødelig slagtilfælde og indlæggelser for hjertesvigt ved brug af standardiserede kriterier.
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Seks måneder
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Kardiovaskulær død
Tidsramme: Seks måneder
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CV død alene vil være et sekundært resultat.
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Seks måneder
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mark Loeb, MD, MSc, McMaster University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
- Jackson LA, Yu O, Heckbert SR, Psaty BM, Malais D, Barlow WE, Thompson WW; Vaccine Safety Datalink Study Group. Influenza vaccination is not associated with a reduction in the risk of recurrent coronary events. Am J Epidemiol. 2002 Oct 1;156(7):634-40. doi: 10.1093/aje/kwf073.
- Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85. doi: 10.1016/S0140-6736(10)61198-1. Erratum In: Lancet. 2010 Dec 11;376(9757):1988. Lajnscak, M [corrected to Lainscak, M]; Rabanedo, I Roldan [corrected to Rabadan, I Roldan]; Leva, M [corrected to Ieva, M].
- Teo K, Yusuf S, Sleight P, Anderson C, Mookadam F, Ramos B, Hilbrich L, Pogue J, Schumacher H; ONTARGET/TRANSCEND Investigators. Rationale, design, and baseline characteristics of 2 large, simple, randomized trials evaluating telmisartan, ramipril, and their combination in high-risk patients: the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (ONTARGET/TRANSCEND) trials. Am Heart J. 2004 Jul;148(1):52-61. doi: 10.1016/j.ahj.2004.03.020.
- Homma S, Thompson JL, Pullicino PM, Levin B, Freudenberger RS, Teerlink JR, Ammon SE, Graham S, Sacco RL, Mann DL, Mohr JP, Massie BM, Labovitz AJ, Anker SD, Lok DJ, Ponikowski P, Estol CJ, Lip GY, Di Tullio MR, Sanford AR, Mejia V, Gabriel AP, del Valle ML, Buchsbaum R; WARCEF Investigators. Warfarin and aspirin in patients with heart failure and sinus rhythm. N Engl J Med. 2012 May 17;366(20):1859-69. doi: 10.1056/NEJMoa1202299. Epub 2012 May 2.
- Naghavi M, Barlas Z, Siadaty S, Naguib S, Madjid M, Casscells W. Association of influenza vaccination and reduced risk of recurrent myocardial infarction. Circulation. 2000 Dec 19;102(25):3039-45. doi: 10.1161/01.cir.102.25.3039.
- Jackson LA, Jackson ML, Nelson JC, Neuzil KM, Weiss NS. Evidence of bias in estimates of influenza vaccine effectiveness in seniors. Int J Epidemiol. 2006 Apr;35(2):337-44. doi: 10.1093/ije/dyi274. Epub 2005 Dec 20.
- Smeeth L, Thomas SL, Hall AJ, Hubbard R, Farrington P, Vallance P. Risk of myocardial infarction and stroke after acute infection or vaccination. N Engl J Med. 2004 Dec 16;351(25):2611-8. doi: 10.1056/NEJMoa041747.
- Phrommintikul A, Kuanprasert S, Wongcharoen W, Kanjanavanit R, Chaiwarith R, Sukonthasarn A. Influenza vaccination reduces cardiovascular events in patients with acute coronary syndrome. Eur Heart J. 2011 Jul;32(14):1730-5. doi: 10.1093/eurheartj/ehr004. Epub 2011 Feb 2.
- ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
- ORIGIN Trial Investigators; Gerstein HC, Bosch J, Dagenais GR, Diaz R, Jung H, Maggioni AP, Pogue J, Probstfield J, Ramachandran A, Riddle MC, Ryden LE, Yusuf S. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012 Jul 26;367(4):319-28. doi: 10.1056/NEJMoa1203858. Epub 2012 Jun 11.
- ACCORD Study Group; Ginsberg HN, Elam MB, Lovato LC, Crouse JR 3rd, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J, Grimm RH, Ismail-Beigi F, Bigger JT, Goff DC Jr, Cushman WC, Simons-Morton DG, Byington RP. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1563-74. doi: 10.1056/NEJMoa1001282. Epub 2010 Mar 14. Erratum In: N Engl J Med. 2010 May 6;362(18):1748.
- Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
- Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954. Erratum In: JAMA. 2013 Apr 10;309(14):1461.
- DataFax - Data Management Software for Clinical Trials. http://www.datafax.com/; accessed February 15, 2013.
- CURRENT-OASIS 7 Investigators; Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Eikelboom JW, Fox KA, Granger CB, Jolly S, Joyner CD, Rupprecht HJ, Widimsky P, Afzal R, Pogue J, Yusuf S. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):930-42. doi: 10.1056/NEJMoa0909475. Erratum In: N Engl J Med. 2010 Oct 14;363(16):1585.
- ACCORD Study Group; Gerstein HC, Miller ME, Genuth S, Ismail-Beigi F, Buse JB, Goff DC Jr, Probstfield JL, Cushman WC, Ginsberg HN, Bigger JT, Grimm RH Jr, Byington RP, Rosenberg YD, Friedewald WT. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med. 2011 Mar 3;364(9):818-28. doi: 10.1056/NEJMoa1006524.
- ORIGIN Trial Investigators; Bosch J, Gerstein HC, Dagenais GR, Diaz R, Dyal L, Jung H, Maggiono AP, Probstfield J, Ramachandran A, Riddle MC, Ryden LE, Yusuf S. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012 Jul 26;367(4):309-18. doi: 10.1056/NEJMoa1203859. Epub 2012 Jun 11.
- Ontario Case Costing Initiative. Toronto, Ontario: Ontario Ministry of Health and Long-term Care, 2005. (Accessed January 29, 2011 at http://www.occp.com).
- Brown PD, Lerner SA. Community-acquired pneumonia. Lancet. 1998 Oct 17;352(9136):1295-302. doi: 10.1016/S0140-6736(98)02239-9.
- Call SA, Vollenweider MA, Hornung CA, Simel DL, McKinney WP. Does this patient have influenza? JAMA. 2005 Feb 23;293(8):987-97. doi: 10.1001/jama.293.8.987.
- Einhorn PT, Davis BR, Massie BM, Cushman WC, Piller LB, Simpson LM, Levy D, Nwachuku CE, Black HR; ALLHAT Collaborative Research Group. The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Heart Failure Validation Study: diagnosis and prognosis. Am Heart J. 2007 Jan;153(1):42-53. doi: 10.1016/j.ahj.2006.10.012.
- Granger CB, Vogel V, Cummings SR, Held P, Fiedorek F, Lawrence M, Neal B, Reidies H, Santarelli L, Schroyer R, Stockbridge NL, Feng Zhao. Do we need to adjudicate major clinical events? Clin Trials. 2008;5(1):56-60. doi: 10.1177/1740774507087972.
- Pogue J, Walter SD, Yusuf S. Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin Trials. 2009 Jun;6(3):239-51. doi: 10.1177/1740774509105223.
- Djulbegovic B, Lacevic M, Cantor A, Fields KK, Bennett CL, Adams JR, Kuderer NM, Lyman GH. The uncertainty principle and industry-sponsored research. Lancet. 2000 Aug 19;356(9230):635-8. doi: 10.1016/S0140-6736(00)02605-2.
- Canadian Community Health Survey: influenza immunization coverage results. http://www.bccdc.ca/imm-vac/BCImmunizationCov/flucoverage/default.htm.
- Mereckiene J, Cotter S, Nicoll A, Levy-Bruhl D, Ferro A, Tridente G, Zanoni G, Berra P, Salmaso S, O'Flanagan D, O Flanagan D; VENICE Project Gatekeepers Group. National seasonal influenza vaccination survey in Europe, 2008. Euro Surveill. 2008 Oct 23;13(43):19017. doi: 10.2807/ese.13.43.19017-en.
- Blank PR, Schwenkglenks M, Szucs TD. Disparities in influenza vaccination coverage rates by target group in five European countries: trends over seven consecutive seasons. Infection. 2009 Oct;37(5):390-400. doi: 10.1007/s15010-009-8467-y. Epub 2009 Sep 18.
- Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP)--United States, 2012-13 influenza season. MMWR Morb Mortal Wkly Rep. 2012 Aug 17;61(32):613-8.
- STATEMENT ON SEASONAL INFLUENZA VACCINE FOR 2012-2013: An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI). Can Commun Dis Rep. 2012 Aug 1;38(ACS-2):1-36. doi: 10.14745/ccdr.v38i00a02. eCollection 2012 Aug 1. No abstract available.
- Natarajan P, Cannon CP. Myocardial infarction vaccine? Evidence supporting the influenza vaccine for secondary prevention. Eur Heart J. 2011 Jul;32(14):1701-3. doi: 10.1093/eurheartj/ehr053. Epub 2011 Mar 15. No abstract available.
- Ciszewski A, Bilinska ZT, Brydak LB, Kepka C, Kruk M, Romanowska M, Ksiezycka E, Przyluski J, Piotrowski W, Maczynska R, Ruzyllo W. Influenza vaccination in secondary prevention from coronary ischaemic events in coronary artery disease: FLUCAD study. Eur Heart J. 2008 Jun;29(11):1350-8. doi: 10.1093/eurheartj/ehm581. Epub 2008 Jan 10.
- Gurfinkel EP, Leon de la Fuente R, Mendiz O, Mautner B. Flu vaccination in acute coronary syndromes and planned percutaneous coronary interventions (FLUVACS) Study. Eur Heart J. 2004 Jan;25(1):25-31. doi: 10.1016/j.ehj.2003.10.018.
- Warren-Gash C, Smeeth L, Hayward AC. Influenza as a trigger for acute myocardial infarction or death from cardiovascular disease: a systematic review. Lancet Infect Dis. 2009 Oct;9(10):601-10. doi: 10.1016/S1473-3099(09)70233-6.
- Keller T, Weeda VB, van Dongen CJ, Levi M. Influenza vaccines for preventing coronary heart disease. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005050. doi: 10.1002/14651858.CD005050.pub2.
- Population Health Research Institute http://www.phri.ca/
- Jackson LA, Nelson JC, Benson P, Neuzil KM, Reid RJ, Psaty BM, Heckbert SR, Larson EB, Weiss NS. Functional status is a confounder of the association of influenza vaccine and risk of all cause mortality in seniors. Int J Epidemiol. 2006 Apr;35(2):345-52. doi: 10.1093/ije/dyi275. Epub 2005 Dec 20.
- Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (TRANSCEND) Investigators; Yusuf S, Teo K, Anderson C, Pogue J, Dyal L, Copland I, Schumacher H, Dagenais G, Sleight P. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. Lancet. 2008 Sep 27;372(9644):1174-83. doi: 10.1016/S0140-6736(08)61242-8. Epub 2008 Aug 29. Erratum In: Lancet. 2008 Oct 18;372(9647):1384.
- ONTARGET Investigators; Yusuf S, Teo KK, Pogue J, Dyal L, Copland I, Schumacher H, Dagenais G, Sleight P, Anderson C. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008 Apr 10;358(15):1547-59. doi: 10.1056/NEJMoa0801317. Epub 2008 Mar 31.
- Johnstone J, Loeb M, Teo KK, Gao P, Dyal L, Liu L, Avezum A, Cardona-Munoz E, Sleight P, Fagard R, Yusuf S; Ongoing Telmisartan Alone and in Combination With Ramipril Global EndPoint Trial (ONTARGET); Telmisartan Randomized Assessment Study in ACE Intolerant Subjects With Cardiovascular Disease (TRANSCEND) Investigators. Influenza vaccination and major adverse vascular events in high-risk patients. Circulation. 2012 Jul 17;126(3):278-86. doi: 10.1161/CIRCULATIONAHA.111.071100. Epub 2012 Jun 19.
- Wang CS, Wang ST, Lai CT, Lin LJ, Chou P. Impact of influenza vaccination on major cause-specific mortality. Vaccine. 2007 Jan 26;25(7):1196-203. doi: 10.1016/j.vaccine.2006.10.015. Epub 2006 Oct 25.
- Armstrong BG, Mangtani P, Fletcher A, Kovats S, McMichael A, Pattenden S, Wilkinson P. Effect of influenza vaccination on excess deaths occurring during periods of high circulation of influenza: cohort study in elderly people. BMJ. 2004 Sep 18;329(7467):660. doi: 10.1136/bmj.38198.594109.AE. Epub 2004 Aug 15.
- Nichol KL, Nordin J, Mullooly J, Lask R, Fillbrandt K, Iwane M. Influenza vaccination and reduction in hospitalizations for cardiac disease and stroke among the elderly. N Engl J Med. 2003 Apr 3;348(14):1322-32. doi: 10.1056/NEJMoa025028.
- Heffelfinger JD, Heckbert SR, Psaty BM, Weiss NS, Thompson WW, Bridges CB, Jackson LA. Influenza vaccination and risk of incident myocardial infarction. Hum Vaccin. 2006 Jul-Aug;2(4):161-6. doi: 10.4161/hv.2.4.2943. Epub 2006 Jul 24.
- Siriwardena AN, Gwini SM, Coupland CA. Influenza vaccination, pneumococcal vaccination and risk of acute myocardial infarction: matched case-control study. CMAJ. 2010 Oct 19;182(15):1617-23. doi: 10.1503/cmaj.091891. Epub 2010 Sep 20.
- Siscovick DS, Raghunathan TE, Lin D, Weinmann S, Arbogast P, Lemaitre RN, Psaty BM, Alexander R, Cobb LA. Influenza vaccination and the risk of primary cardiac arrest. Am J Epidemiol. 2000 Oct 1;152(7):674-7. doi: 10.1093/aje/152.7.674.
- Lavallee P, Perchaud V, Gautier-Bertrand M, Grabli D, Amarenco P. Association between influenza vaccination and reduced risk of brain infarction. Stroke. 2002 Feb;33(2):513-8. doi: 10.1161/hs0202.102328. Erratum In: Stroke 2002 Apr;33(4):1171.
- Meyers D, Beahm D, Jurisich P, Milford C, Edlavich S. Influenza and pneumococcal vaccinations fail to prevent myocardial infarction. Heart Drug. 2004;4:96 -100.
- Remme WJ, Torp-Pedersen C, Cleland JG, Poole-Wilson PA, Metra M, Komajda M, Swedberg K, Di Lenarda A, Spark P, Scherhag A, Moullet C, Lukas MA. Carvedilol protects better against vascular events than metoprolol in heart failure: results from COMET. J Am Coll Cardiol. 2007 Mar 6;49(9):963-71. doi: 10.1016/j.jacc.2006.10.059. Epub 2007 Feb 20.
- Gwini SM, Coupland CA, Siriwardena AN. The effect of influenza vaccination on risk of acute myocardial infarction: self-controlled case-series study. Vaccine. 2011 Feb 1;29(6):1145-9. doi: 10.1016/j.vaccine.2010.12.017. Epub 2010 Dec 18.
- Kawano H, Motoyama T, Hirashima O, Hirai N, Miyao Y, Sakamoto T, Kugiyama K, Ogawa H, Yasue H. Hyperglycemia rapidly suppresses flow-mediated endothelium-dependent vasodilation of brachial artery. J Am Coll Cardiol. 1999 Jul;34(1):146-54. doi: 10.1016/s0735-1097(99)00168-0.
- Lundman P, Eriksson M, Schenck-Gustafsson K, Karpe F, Tornvall P. Transient triglyceridemia decreases vascular reactivity in young, healthy men without risk factors for coronary heart disease. Circulation. 1997 Nov 18;96(10):3266-8. doi: 10.1161/01.cir.96.10.3266.
- Conti CR. Vascular events responsible for thrombotic occlusion of a blood vessel. Clin Cardiol. 1993 Nov;16(11):761-2. doi: 10.1002/clc.4960161103.
- Wanishsawad C, Zhou YF, Epstein SE. Chlamydia pneumoniae-induced transactivation of the major immediate early promoter of cytomegalovirus: potential synergy of infectious agents in the pathogenesis of atherosclerosis. J Infect Dis. 2000 Feb;181(2):787-90. doi: 10.1086/315235.
- Davies MJ. The composition of coronary-artery plaques. N Engl J Med. 1997 May 1;336(18):1312-4. doi: 10.1056/NEJM199705013361809. No abstract available.
- Chan NN, Colhoun HM, Vallance P. Cardiovascular risk factors as determinants of endothelium-dependent and endothelium-independent vascular reactivity in the general population. J Am Coll Cardiol. 2001 Dec;38(7):1814-20. doi: 10.1016/s0735-1097(01)01669-2.
- Warren-Gash C, Hayward AC, Hemingway H, Denaxas S, Thomas SL, Timmis AD, Whitaker H, Smeeth L. Influenza infection and risk of acute myocardial infarction in England and Wales: a CALIBER self-controlled case series study. J Infect Dis. 2012 Dec 1;206(11):1652-9. doi: 10.1093/infdis/jis597. Epub 2012 Oct 9.
- Pesonen E, Andsberg E, Grubb A, Rautelin H, Meri S, Persson K, Puolakkainen M, Sarna S, Ohlin H. Elevated infection parameters and infection symptoms predict an acute coronary event. Ther Adv Cardiovasc Dis. 2008 Dec;2(6):419-24. doi: 10.1177/1753944708098695.
- Guan XR, Li X, Xin XM, Jiang LX, Cui LY, Wang LF, Li HY. Influenza virus infection and risk of acute myocardial infarction. Inflammation. 2008 Aug;31(4):266-72. doi: 10.1007/s10753-008-9074-2.
- Kinlay S, Ganz P. Role of endothelial dysfunction in coronary artery disease and implications for therapy. Am J Cardiol. 1997 Nov 6;80(9A):11I-16I. doi: 10.1016/s0002-9149(97)00793-5.
- Zheng Z, Mittelman M, Tofler G, Pomeroy C, Dampier C, Wides B, Muller J. Infections prior to acute myocardial infarction onset. J Am Coll Cardiol. 1998;31(suppl 1):132-133.
- Tracking Heart Disease and Stroke in Canada. Released June 2009.
- Statistics Canada. Morality, Summary List of Causes 2008. Released October 18, 2011.
- Causes of death 2008, World Health Organization, Geneva, http://www.who.int/healthinfo/ global_burden_disease/ cod_2008_sources_methods.pdf.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2015
Primær færdiggørelse (Faktiske)
1. december 2015
Studieafslutning (Faktiske)
1. december 2015
Datoer for studieregistrering
Først indsendt
13. september 2013
Først indsendt, der opfyldte QC-kriterier
13. september 2013
Først opslået (Skøn)
18. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. oktober 2018
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RCT IVVE Pilot
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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Kliniske forsøg med Hjertefejl
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Region SkaneTilmelding efter invitationHjertesvigt New York Heart Association (NYHA) klasse II | Hjertesvigt New York Heart Association (NYHA) klasse IIISverige
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Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan... og andre samarbejdspartnereIkke rekrutterer endnuHjertesvigt, systolisk | Hjertesvigt med reduceret udstødningsfraktion | Hjertesvigt New York Heart Association Klasse IV | Hjertesvigt New York Heart Association Klasse IIIPolen
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University of WashingtonAmerican Heart AssociationAfsluttetHjertesvigt, Kongestiv | Mitokondriel ændring | Hjertesvigt New York Heart Association Klasse IVForenede Stater
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Novartis PharmaceuticalsAfsluttetPatienter, der med succes afslutter den 12-måneders behandlingsperiode i kernestudiet (de Novo Heart-modtagere), som var interesserede i at blive behandlet med EC-MPS
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University Hospital, GasthuisbergUkendtTransient Left Ventricular Ballooning SyndromeBelgien
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NYU Langone HealthRekrutteringTako-tsubo kardiomyopati | Takotsubo kardiomyopati | Broken Heart SyndromeForenede Stater
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French Cardiology SocietyAfsluttet
Kliniske forsøg med inaktiveret trivalent influenzavaccine
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Abbott BiologicalsQuintiles, Inc.Afsluttet
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Solvay BiologicalsAfsluttet
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SeqirusAfsluttetInfluenzaKalkun, Filippinerne, Thailand, Malaysia, Litauen, Colombia, Tjekkiet, Estland, Bulgarien, Letland, Polen, Rumænien
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Abbott BiologicalsQuintiles, Inc.Afsluttet
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Butantan InstituteAfsluttet
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M.D. Anderson Cancer CenterNational Institutes of Health (NIH)Afsluttet
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Inova Health Care ServicesAfsluttetInfluenza, menneske | TransplantationsinfektionForenede Stater
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National Institute of Allergy and Infectious Diseases...The Emmes Company, LLCAfsluttet
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Green Cross CorporationAfsluttet
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National Institute of Allergy and Infectious Diseases...AfsluttetInfluenzaForenede Stater