2022
Central vs site outcome adjudication in the IRIS trial
Forman R, Viscoli CM, Bath PM, Furie KL, Guarino P, Inzucchi SE, Young L, Kernan WN. Central vs site outcome adjudication in the IRIS trial. Journal Of Stroke And Cerebrovascular Diseases 2022, 31: 106667. PMID: 35901589, DOI: 10.1016/j.jstrokecerebrovasdis.2022.106667.Peer-Reviewed Original ResearchConceptsCentral adjudicationHazard ratioStroke definitionsRecent transient ischemic attackInsulin Resistance InterventionMain secondary outcomesShorter symptom durationTransient ischemic attackPrevention of strokeNormal brain imagingClinical trial researchIschemic attackIschemic strokeSecondary outcomesSymptom durationPrimary outcomeStroke trialsIRIS trialMyocardial infarctionOutcome definitionsStroke typeOutcome eventsAdjudicated eventsOutcome adjudicationResistance Intervention
2020
Adherence to study drug in a stroke prevention trial"?>
Kiran A, Viscoli CM, Furie KL, Gorman M, Kernan WN. Adherence to study drug in a stroke prevention trial"?>. Journal Of Stroke And Cerebrovascular Diseases 2020, 29: 105048. PMID: 32912514, PMCID: PMC7487071, DOI: 10.1016/j.jstrokecerebrovasdis.2020.105048.Peer-Reviewed Original ResearchConceptsRate of discontinuationStudy drugDrug holidayTreatment groupsActive study drugAdverse effectsInsulin Resistance InterventionPremature drug discontinuationRecent ischemic strokeStroke Prevention TrialDouble-blind trialTransient ischemic attackClinical trial researchPhases of adherenceDrug discontinuationIschemic attackStroke preventionDiscontinuation ratesIschemic strokeActive therapyMedical therapyPatient adherencePrevention trialsStroke trialsPharmacodynamic effects
2017
Effects of pioglitazone on cognitive function in patients with a recent ischaemic stroke or TIA: a report from the IRIS trial
Furie KL, Viscoli CM, Gorman M, Ford GA, Young LH, Inzucchi SE, Guarino PD, Lovejoy AM, Conwit R, Tanne D, Kernan WN. Effects of pioglitazone on cognitive function in patients with a recent ischaemic stroke or TIA: a report from the IRIS trial. Journal Of Neurology Neurosurgery & Psychiatry 2017, 89: 21. PMID: 28939682, DOI: 10.1136/jnnp-2017-316361.Peer-Reviewed Original ResearchConceptsTransient ischemic attackRecent ischemic strokeIschemic strokeCognitive functionHomeostasis model assessment insulin resistance scoreModified Mini-Mental State Examination scoresAssessment-insulin resistance scoreMini-Mental State Examination scoreInsulin Resistance InterventionPoststroke cognitive functionVascular risk factorsEffect of pioglitazoneInsulin-resistant patientsState Examination scoreIschemic attackPioglitazone groupPlacebo groupIRIS trialStroke trialsCerebrovascular diseaseInsulin resistanceRisk factorsCognitive dysfunctionPatientsResistance InterventionSmoking cessation and outcome after ischemic stroke or TIA
Epstein KA, Viscoli CM, Spence JD, Young LH, Inzucchi SE, Gorman M, Gerstenhaber B, Guarino PD, Dixit A, Furie KL, Kernan WN, Bladin C, Davis S, Wijeratne T, Levi C, Parsons M, Brodtmann A, Ng S, Archer J, Delcourt C, Winder T, Berger L, Boulanger J, Chan R, Spence J, Durocher A, Mackey A, Verreault S, Minuk J, Penn A, Shuaib A, Cote R, Selchen D, Bayer N, Sweet M, Malik S, Stotts G, Griewing B, Soda H, Weinhardt R, Berrouschot J, Stoll A, Witte O, Günther A, Bodechtel U, Schminke U, Hobohm C, Hetzel A, Lambeck J, Wartenberg K, Huttner H, Dittrich R, Nabavi D, Gröschel K, Thomalla G, Rosenkranz M, Jander S, Meisel A, Ludolph A, Althaus K, Huber R, Lorenz M, Tanne D, Merzlyak O, Bornstein N, Telman G, Lampl Y, Streifler J, Weller B, Ifergane G, Wirgin Y, Carolei A, Toni D, Stanzione P, Micieli G, Agnelli G, Caso V, Gandolfo C, Comi G, Consoli D, Rasura M, Di Lazzaro V, Dixit A, Jupp B, Shaw L, Salih I, Esisi B, Power M, Strain W, Elyas S, Manawadu D, Kalra L, O'Brien E, Warburton E, Chatterjee K, Hargroves D, Blight A, Moynihan B, Markus H, Macleod M, Broughton D, Rodgers H, Hlaing T, Muir S, Sajid M, Bath P, Price C, Sekaran L, Vahidassr D, Muir K, McIlmoyle J, Datta P, Davey R, Langhorne P, Stott D, Datta P, England T, Muhidden K, O'Connell J, Majmudar N, Schindler J, Clark W, Sethi P, Rordorf G, Kleindorfer D, Silliman S, Gorman M, Kelly M, Singleton L, Meyer B, Jackson C, Walker J, Ehtisham A, Goodpasture H, Wang D, Fayad P, Cordina S, Naritoku D, Chiu D, Lukovits T, Goddeau R, Clark‐Arbogast R, Leigh R, Wityk R, Pettigrew L, Tayal A, Jarouse J, Friday G, Sen S, Kim A, Johnston S, Elkins J, Barrett A, Leira E, Kelly A, Burgin S, Rempe D, Jacoby M, Hughes D, Majersik J, Skalabrin E, Lee J, Hsu C, Sundararajan S, Slivka A, Minagar A, Alicic R, Geraghty M, Kase C, Lansberg M, Albers G, Dietrich D, Hanna J, Gentile N, Santiago F, Katzan I, Ching M, Sawyer, Warwick T, Yilmaz E, Pedelty L, Schneck M, Coull B, Solenski N, Johnston K, Lee V, Prabhakaran S, Johnson M, Silverman I, Salgado M, Birkhahn R, Strawsburg R, Altafullah I, Cohen D, Zweifler R, Lee Kwen P, Hammer M, Vora N, Tietjen G, Albakri E, Dandapani B, Jickling G, Verro P, Roller M, Hughes R, Simpson J, Vidic T, Lash S, Sigsbee B, Rosenbaum D, Fonzetti P, Fleck J, Goldszmidt A, Alexandrov A, Halsey J, Hart R, Sattin J, Kumar S, Book D, Torbey M, Poock J, King M, Graham G, Sung G, Mirsen T, Dromerick A, Runheim A, Jackson C, Feen E, Reichwein R, Waters M, Amory C, Bernardini G, Bell R, Diamond B, Rosenbaum D, Palestrant D, Segal A, Burger K, Schwartz R, Mitsias P, Kramer J, Kramer J, Robbins D, Silver B, Easton J, Feldmann E, Rymer M, Dorssom J, Ali L, Ovbiagele B, Kirshner H. Smoking cessation and outcome after ischemic stroke or TIA. Neurology 2017, 89: 1723-1729. PMID: 28887378, PMCID: PMC5644463, DOI: 10.1212/wnl.0000000000004524.Peer-Reviewed Original ResearchConceptsMyocardial infarctionIschemic strokeIndex eventProspective observational cohort studyInsulin Resistance InterventionHistory of hypertensionObservational cohort studyDiastolic blood pressureHistory of strokeCoronary artery diseaseTime of randomizationTobacco use historySignificant health benefitsRecurrent strokeNondiabetic menCohort studyCurrent smokersTrial cohortArtery diseaseBlood pressurePrimary outcomeIRIS trialStroke trialsCigarette smokingSmoking cessation
2016
Pioglitazone and Risk for Bone Fracture: Safety Data From a Randomized Clinical Trial
Viscoli CM, Inzucchi SE, Young LH, Insogna KL, Conwit R, Furie KL, Gorman M, Kelly MA, Lovejoy AM, Kernan WN, Investigators F. Pioglitazone and Risk for Bone Fracture: Safety Data From a Randomized Clinical Trial. The Journal Of Clinical Endocrinology & Metabolism 2016, 102: 914-922. PMID: 27935736, PMCID: PMC5460686, DOI: 10.1210/jc.2016-3237.Peer-Reviewed Original ResearchConceptsTransient ischemic attackIschemic strokeFracture riskBone fracturesRisk/benefit ratioAbsolute fracture riskInsulin Resistance InterventionPlacebo-treated patientsIschemic attackNondiabetic patientsPlacebo groupCardiovascular riskBone healthStroke trialsNondiabetic participantsPrevent fallsClinical trialsRelative riskSafety dataFracture classificationQuarterly interviewsPioglitazonePatientsResistance InterventionRisk incrementTaking care of volunteers in a stroke trial: a new assisted-management strategy
Stuart AC, Sico JJ, Viscoli CM, Tayal AH, Inzucchi SE, Ford GA, Furie KL, Cote R, Spence JD, Tanne D, Kernan WN. Taking care of volunteers in a stroke trial: a new assisted-management strategy. Stroke And Vascular Neurology 2016, 1: 108. PMID: 28959471, PMCID: PMC5435205, DOI: 10.1136/svn-2016-000029.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnticholesteremic AgentsAntihypertensive AgentsBiomarkersBlood CoagulationBlood PressureCholesterol, LDLDouble-Blind MethodEuropeFemaleFibrinolytic AgentsHumansHypoglycemic AgentsInsulin ResistanceIschemic Attack, TransientIschemic StrokeIsraelMaleMiddle AgedNorth AmericaPioglitazoneRecurrenceRisk AssessmentRisk FactorsRisk Reduction BehaviorSecondary PreventionTime FactorsTreatment OutcomeConceptsPersonal healthcare providerBlood pressureStroke trialsPreventive careTrial participantsLow-density lipoprotein cholesterolPrevention goalsInsulin Resistance InterventionTransient ischemic attackPrevention of strokeSecondary prevention goalsEvidence-based careProportion of participantsIschemic attackAntithrombotic therapyIschemic strokeLipoprotein cholesterolSecondary preventionAntithrombotic useStroke therapyInsulin sensitisersMyocardial infarctionAnnual visitsHealthcare providersResistance InterventionPioglitazone Prevents Diabetes in Patients With Insulin Resistance and Cerebrovascular Disease.
Inzucchi SE, Viscoli CM, Young LH, Furie KL, Gorman M, Lovejoy AM, Dagogo-Jack S, Ismail-Beigi F, Korytkowski MT, Pratley RE, Schwartz GG, Kernan WN. Pioglitazone Prevents Diabetes in Patients With Insulin Resistance and Cerebrovascular Disease. Diabetes Care 2016, 39: 1684-92. PMID: 27465265, PMCID: PMC5033078, DOI: 10.2337/dc16-0798.Peer-Reviewed Original ResearchConceptsTransient ischemic attackRecent ischemic strokeInsulin resistanceIschemic strokeHOMA-IRInsulin Resistance InterventionMajor cardiovascular eventsMean HOMA-IRHistory of diabetesSubsequent ischemic eventsHomeostasis model assessmentRisk of diabetesΜIU/mLFPG testingPioglitazone groupCardiovascular eventsIschemic attackPlacebo groupFirst medicationIschemic eventsMean FPGDiabetes onsetDiabetes preventionCerebrovascular diseaseStroke trials
2005
Altruism as a reason for participation in clinical trials was independently associated with adherence
Rosenbaum JR, Wells CK, Viscoli CM, Brass LM, Kernan WN, Horwitz RI. Altruism as a reason for participation in clinical trials was independently associated with adherence. Journal Of Clinical Epidemiology 2005, 58: 1109-1114. PMID: 16223653, DOI: 10.1016/j.jclinepi.2005.03.014.Peer-Reviewed Original ResearchConceptsClinical trialsBetter functional statusStudy medicationMedical regimenRecruitment of participantsClinical featuresStroke trialsFunctional statusWomen's EstrogenStratified analysisMultivariable regressionClinical researchEstrogenTrialsAdherenceBaseline featuresSocial supportFurther investigationWomenParticipantsAltruistic reasonsPossible contributionHigh levelsPlaceboMedicationsEstrogen therapy and risk of cognitive decline: Results from the Women's Estrogen for Stroke Trial (WEST)
Viscoli CM, Brass LM, Kernan WN, Sarrel PM, Suissa S, Horwitz RI. Estrogen therapy and risk of cognitive decline: Results from the Women's Estrogen for Stroke Trial (WEST). American Journal Of Obstetrics And Gynecology 2005, 192: 387-393. PMID: 15695976, DOI: 10.1016/j.ajog.2004.08.017.Peer-Reviewed Original ResearchConceptsMini-Mental State ExaminationEstrogen therapyCognitive declineNormal Mini-Mental State ExaminationDouble-blind trialSecondary stroke preventionTransient ischemic attackIschemic attackPostmenopausal womenStroke preventionRecent strokeStroke trialsCerebrovascular diseaseWomen's EstrogenEstradiol-17betaState ExaminationCognitive measuresEstrogenWomenNormal functionDomain measuresLess declineTherapyStrokeRisk
2003
Influence of race, clinical, and other socio-demographic features on trial participation
Corbie-Smith G, Viscoli CM, Kernan WN, Brass LM, Sarrel P, Horwitz RI. Influence of race, clinical, and other socio-demographic features on trial participation. Journal Of Clinical Epidemiology 2003, 56: 304-309. PMID: 12767406, DOI: 10.1016/s0895-4356(03)00046-5.Peer-Reviewed Original ResearchConceptsTrial participationPrevious estrogen useClinical trial participationHistory of hysterectomyEstrogen useClinical characteristicsStroke trialsWomen's EstrogenClinical trialsConsent ratesCognitive impairmentSocio-demographic featuresMultivariate modelInfluence of raceHysterectomyEstrogenWomen's decisionsTrialsEthnic groupsImpairmentVisitsWomen
1998
Estrogen after ischemic stroke: Clinical basis and design of The Women's Estrogen for Stroke Trial
Kernan W, Brass L, Viscoli C, Sarrel P, Makuch R, Horwitz R. Estrogen after ischemic stroke: Clinical basis and design of The Women's Estrogen for Stroke Trial. Journal Of Stroke And Cerebrovascular Diseases 1998, 7: 85-95. PMID: 17895061, DOI: 10.1016/s1052-3057(98)80026-8.Peer-Reviewed Original ResearchIschemic strokeStroke trialsWomen's EstrogenSecondary stroke preventionStroke risk factorsTransient ischemic attackTime of strokeUse of estrogenEffectiveness of estrogenIschemic attackRecurrent strokeEstrogen usersPostmenopausal womenStroke preventionUterine bleedingEndometrial hyperplasiaAsymptomatic womenVaginal ultrasonographyUterine cancerRisk factorsImproved outcomesObservational studyTherapeutic effectClinical basisExclusion criteria