2023
Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations
Broderick J, Silva G, Selim M, Kasner S, Aziz Y, Sutherland J, Jauch E, Adeoye O, Hill M, Mistry E, Lyden P, Mocco J, Smith E, Hernandez-Jimenez M, Deljkich E, Kamel H, Alemseged F, Bates K, Bhatt N, Boltze J, Campbell B, Favilla C, Fiorella D, Grotta J, Haddad W, Heidt J, Liebeskind D, Lightfoot N, Jubin R, Khatri P, Lansberg M, Lynch J, Margolin D, Nguyen T, Nogueira R, Samaniego E, Saver J, Schwamm L, Sheth K, Smith W, Wadhwa M, Wakhloo A, Wechsler L, Xiong Y, Zachrison K. Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations. Stroke 2023, 54: 2698-2707. PMID: 37694403, PMCID: PMC10542906, DOI: 10.1161/strokeaha.123.044149.Peer-Reviewed Original ResearchConceptsAcute stroke trialsStroke trialsStroke Treatment Academic Industry RoundtableEnrollment of participantsNational Institute of Neurological DisordersImprove patient outcomesImproving trial efficiencySite championsPharmacist availabilityStroke physiciansStudy teamStudy coordinatorsEligibility criteriaEnhance enrollmentImprove enrollmentStudy proceduresPatient outcomesConsent proceduresUS Food and Drug AdministrationAction itemsConsensus recommendationsFood and Drug AdministrationStroke outcomeEnrollmentNational InstituteUnderstanding Patterns of Missingness in Acute Ischemic Stroke Trials: A Secondary Analysis of Pooled Participant-Level Follow-Up Data
de Havenon A, Bangad A, Skolarus L, Aldridge C, Braun R, Cole J, Cramer S, Lindgren A, Sunmonu N, Worrall B, Lohse K. Understanding Patterns of Missingness in Acute Ischemic Stroke Trials: A Secondary Analysis of Pooled Participant-Level Follow-Up Data. Stroke 2023, 54: e201-e202. PMID: 36896708, PMCID: PMC10133020, DOI: 10.1161/strokeaha.122.042168.Peer-Reviewed Original Research
2022
Subsequent ischemic stroke and tobacco smoking: A secondary analysis of the POINT trial
Lang A, de Havenon A, Mac Grory B, Henninger N, Shu L, Furie K, Easton J, Kim A, Johnston S, Yaghi S. Subsequent ischemic stroke and tobacco smoking: A secondary analysis of the POINT trial. European Stroke Journal 2022, 8: 328-333. PMID: 37021190, PMCID: PMC10069178, DOI: 10.1177/23969873221148224.Peer-Reviewed Original ResearchConceptsSubsequent ischemic strokeEffect of clopidogrelSubsequent stroke riskIschemic strokeMajor hemorrhagePoint trialStroke riskSmoking statusMinor Ischemic Stroke (POINT) trialSubgroup interaction analysesMultivariable Cox regressionMinor ischemic strokeIschemic stroke trialsEffect of smokingNon-significant trendNew TIACurrent smokersStroke trialsTobacco smokingCox regressionIndex eventSmokersSecondary analysisClopidogrelStrokeCentral 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 InterventionThe Stroke Preclinical Assessment Network: Rationale, Design, Feasibility, and Stage 1 Results
Lyden PD, Bosetti F, Diniz MA, Rogatko A, Koenig JI, Lamb J, Nagarkatti KA, Cabeen RP, Hess DC, Kamat PK, Khan MB, Wood K, Dhandapani K, Arbab AS, Leira EC, Chauhan AK, Dhanesha N, Patel RB, Kumskova M, Thedens D, Morais A, Imai T, Qin T, Ayata C, Boisserand LSB, Herman AL, Beatty HE, Velazquez SE, Diaz-Perez S, Sanganahalli BG, Mihailovic JM, Hyder F, Sansing LH, Koehler RC, Lannon S, Shi Y, Karuppagounder SS, Bibic A, Akhter K, Aronowski J, McCullough LD, Chauhan A, Goh A, Siddiqui S, Sheth K, Matouk C, Cruz C, Zhou J, Dawson V, Dawson T, Liang J, van Zijl P, Zeiler S, Taylor Kimberly W, Erdogan T, Yu L, Mandeville J, Whittier J. The Stroke Preclinical Assessment Network: Rationale, Design, Feasibility, and Stage 1 Results. Stroke 2022, 53: 1802-1812. PMID: 35354299, PMCID: PMC9038686, DOI: 10.1161/strokeaha.121.038047.Peer-Reviewed Original ResearchConceptsPreclinical assessmentStroke treatmentCandidate treatmentMiddle cerebral artery occlusion (MCAO) surgeryClinical stroke trialsSuccessful stroke treatmentInclusion/exclusion criteriaStroke clinical trialsClinical trial designYoung male animalsComorbid diseasesOcclusion surgeryCerebral ischemiaNeurological disabilityComorbid conditionsStroke trialsProtocol adherenceBlinded assessmentSuch therapyClinical trialsClinical studiesExclusion criteriaTrial designAged animalsOutcome assessmentEfficacy of lower doses of pioglitazone after stroke or transient ischaemic attack in patients with insulin resistance
Spence JD, Viscoli C, Kernan WN, Young LH, Furie K, DeFronzo R, Abdul‐Ghani M, Dandona P, Inzucchi SE. Efficacy of lower doses of pioglitazone after stroke or transient ischaemic attack in patients with insulin resistance. Diabetes Obesity And Metabolism 2022, 24: 1150-1158. PMID: 35253334, DOI: 10.1111/dom.14687.Peer-Reviewed Original ResearchConceptsNew-onset diabetesAdjusted hazard ratioHazard ratioLow dosesAdverse effectsInsulin Resistance InterventionTransient ischemic attackSecondary prevention strategiesAnti-atherosclerotic propertiesInsulin-sensitizing drugsLess adverse effectsIschemic attackStudy drugHeart failureStroke trialsAdverse outcomesInsulin resistancePioglitazonePrevention strategiesHigh dosesResistance InterventionFull doseWeight gainDiabetesPatientsAssociation of Modified Rankin Scale With Recovery Phenotypes in Patients With Upper Extremity Weakness After Stroke
Erler K, Wu R, DiCarlo J, Petrilli M, Gochyyev P, Hochberg L, Kautz S, Schwamm L, Cramer S, Finklestein S, Lin D. Association of Modified Rankin Scale With Recovery Phenotypes in Patients With Upper Extremity Weakness After Stroke. Neurology 2022, 98: e1877-e1885. PMID: 35277444, PMCID: PMC9109148, DOI: 10.1212/wnl.0000000000200154.Peer-Reviewed Original ResearchConceptsModified Rankin ScaleUpper extremity weaknessMRS scoreStroke trialsFunctional outcomeOutcome measuresMRS levelsExtremity weaknessRankin ScaleMRS outcomesMotor impairmentFuture stroke trialsDaily living statusUpper extremity impairmentMeaningful changeGlobal outcome measuresMeaningful clinical changeIschemic strokeFugl-MeyerGrip strengthMotor phenotypeClinical changesClinical careDaily livingPatients
2021
Acute Stroke Imaging Research Roadmap IV: Imaging Selection and Outcomes in Acute Stroke Clinical Trials and Practice
Campbell B, Lansberg M, Broderick J, Derdeyn C, Khatri P, Sarraj A, Saver J, Vagal A, Albers G, Adeoye O, Ansari S, Boltze J, Buchan A, Chaisinanunkul N, Chen C, Davis T, Ermakova T, Fisher M, Haddad W, Hill M, Houser G, Jadhav A, Kimberly W, Landen J, Liebeskind D, Lyden P, Lynch J, Mansi C, Mocco J, Nogueira R, Savitz S, Schwamm L, Sheth K, Solberg Y, Venkatasubramanian C, Warach S, Wechsler L, Zhu B, Ziogas N. Acute Stroke Imaging Research Roadmap IV: Imaging Selection and Outcomes in Acute Stroke Clinical Trials and Practice. Stroke 2021, 52: 2723-2733. PMID: 34233464, PMCID: PMC8316368, DOI: 10.1161/strokeaha.121.035132.Peer-Reviewed Original ResearchConceptsPrimary stroke centerAcute stroke clinical trialsStroke centersStroke clinical trialsReperfusion therapyClinical trialsConsensus recommendationsComprehensive stroke centerAcute stroke trialsImaging sessionOptimal imaging strategyExtended time windowStroke neurologistsAcute strokeStroke trialsImaging selectionComputed tomographyTreatment windowUS FoodDrug AdministrationNeurological disordersStroke imagingTrialsNational InstituteOptimal imagingEvaluation of Systolic Blood Pressure, Use of Aspirin and Clopidogrel, and Stroke Recurrence in the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke Trial
de Havenon A, Johnston SC, Easton JD, Kim AS, Sheth KN, Lansberg M, Tirschwell D, Mistry E, Yaghi S. Evaluation of Systolic Blood Pressure, Use of Aspirin and Clopidogrel, and Stroke Recurrence in the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke Trial. JAMA Network Open 2021, 4: e2112551. PMID: 34086033, PMCID: PMC8178708, DOI: 10.1001/jamanetworkopen.2021.12551.Peer-Reviewed Original ResearchConceptsBaseline systolic blood pressureDual antiplatelet therapySystolic blood pressureTransient ischemic attackMinor Ischemic Stroke (POINT) trialNew transient ischemic attackAcute ischemic strokeIschemic strokeIschemic stroke trialsStroke recurrenceHazard ratioBlood pressurePrimary outcomeStroke trialsElevated baseline systolic blood pressureFit Cox proportional hazards modelsHigher baseline systolic blood pressureElevated systolic blood pressureCox proportional hazards modelDays of randomizationFuture stroke riskIschemic stroke recurrenceUse of aspirinSubgroup of patientsProportional hazards modelVariability of the Modified Rankin Scale Score Between Day 90 and 1 Year After Ischemic Stroke
de Havenon A, Tirschwell DL, Heitsch L, Cramer SC, Braun R, Cole J, Reddy V, Majersik JJ, Lindgren A, Worrall BB. Variability of the Modified Rankin Scale Score Between Day 90 and 1 Year After Ischemic Stroke. Neurology Clinical Practice 2021, 11: e239-e244. PMID: 34484897, PMCID: PMC8382369, DOI: 10.1212/cpj.0000000000000954.Peer-Reviewed Original ResearchModified Rankin ScaleTrial's primary outcomePrimary outcomeIschemic strokeDay 90Stroke onsetStroke trialsStroke (NINDS) rt-PA Stroke StudyModified Rankin Scale scoreAcute ischemic strokeProportion of patientsIschemic stroke onsetRankin Scale scoreClinical trial designTraditional outcome measuresMRS improvementMRS shiftStroke IIIRecurrent strokeRankin ScaleInterventional managementClinical evolutionStroke StudyRehabilitative therapyAlbumin treatment
2020
Amendment on the article “Missing outcome data management in acute stroke trials testing iv thrombolytics: Is there risk of bias?”
Fernandez-Ferro J, Schwamm L, Lyden P, Lees K. Amendment on the article “Missing outcome data management in acute stroke trials testing iv thrombolytics: Is there risk of bias?”. European Stroke Journal 2020, 5: 453-454. PMID: 33598566, PMCID: PMC7856594, DOI: 10.1177/2396987320957188.Peer-Reviewed Original ResearchAdherence 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 effectsStroke in Pregnancy: A Focused Update.
Miller EC, Leffert L. Stroke in Pregnancy: A Focused Update. Anesthesia & Analgesia 2020, 130: 1085-1096. PMID: 31124843, PMCID: PMC7035913, DOI: 10.1213/ane.0000000000004203.Peer-Reviewed Original ResearchConceptsHemorrhagic strokeCesarean deliveryPregnant womenIschemic strokeGeneral anesthesiaObstetric anesthesiologistHigh-risk obstetriciansLarge stroke trialsPregnancy-related strokeHigh-risk groupRisk of herniationMaternal strokeObstetric indicationsTherapeutic anticoagulationExtremity weaknessStroke neurologistsAcute strokeDevastating complicationNeuraxial analgesiaNonpregnant womenStroke subtypesIntracranial hypertensionRecent strokeVaginal deliveryStroke trialsMissing outcome data management in acute stroke trials testing iv thrombolytics. Is there risk of bias?
Fernandez-Ferro J, Schwamm L, Descalzo M, MacIsaac R, Lyden P, Lees K. Missing outcome data management in acute stroke trials testing iv thrombolytics. Is there risk of bias? European Stroke Journal 2020, 5: 148-154. PMID: 32637648, PMCID: PMC7313360, DOI: 10.1177/2396987320905457.Peer-Reviewed Original ResearchAcute stroke trialsStroke trialsOdds ratioOutcome dataRankin ScaleNon-thrombolysed patientsRankin Scale 90Ischemic stroke patientsInternational Stroke TrialRisk of biasMultiple imputationLast observationOdds ratio estimatesTreatment odds ratiosStroke patientsClinical trialsOutcome comparisonsPatientsTrials
2019
The Mild and Rapidly Improving Stroke Study (MaRISS): Rationale and design
Romano J, Gardener H, Campo-Bustillo I, Khan Y, Riley N, Tai S, Sacco R, Khatri P, Smith E, Schwamm L. The Mild and Rapidly Improving Stroke Study (MaRISS): Rationale and design. International Journal Of Stroke 2019, 14: 983-986. PMID: 31496438, DOI: 10.1177/1747493019873595.Peer-Reviewed Original ResearchConceptsStroke symptomsStroke Impact Scale-16Actual treatment ratesMild ischemic strokePrimary safety outcomeSymptomatic hemorrhagic transformationProportion of patientsThird of patientsProspective observational studyEffect of alteplaseAcute stroke trialsLong-term outcomesPredictors of outcomeAlteplase treatmentHemorrhagic transformationIschemic strokeRankin ScaleSecondary outcomesBarthel IndexPrimary outcomeResidual disabilityStroke presentationRetrospective studyStroke StudyStroke trialsSEIMLESS: Simultaneous Extracranial, Intracranial Management of (tandem) LESsions in Stroke
Sultan-Qurraie A, Witt T, de Havenon A, Ribo M, Zaidat OO. SEIMLESS: Simultaneous Extracranial, Intracranial Management of (tandem) LESsions in Stroke. Journal Of NeuroInterventional Surgery 2019, 11: 879. PMID: 30674634, DOI: 10.1136/neurintsurg-2018-014403.Peer-Reviewed Original ResearchConceptsTandem lesionsAcute ischemic stroke patientsCerebral Infarction scoreDistal intracranial occlusionsPost-procedural ThrombolysisIschemic stroke patientsIntracranial arterial occlusionTotal fluoroscopy timeCase-control studyAmount of contrastIntracranial recanalizationEndovascular thrombectomyRecanalization timeArterial punctureIntracranial occlusionArterial occlusionStroke patientsStroke trialsArterial accessConcomitant occlusionDistal lesionsFluoroscopy timeClinical dataProximal vesselsPatients
2018
Distance from Home to Research Center: A Barrier to In-Person Visits but Not Treatment Adherence in a Stroke Trial
Leira EC, Viscoli CM, Polgreen LA, Gorman M, Kernan WN. Distance from Home to Research Center: A Barrier to In-Person Visits but Not Treatment Adherence in a Stroke Trial. Neuroepidemiology 2018, 50: 137-143. PMID: 29587267, PMCID: PMC5975097, DOI: 10.1159/000486315.Peer-Reviewed Original ResearchConceptsPerson visitsStroke trialsTreatment adherenceStudy centersInsulin Resistance InterventionLogistic regression modelsIndependent predictorsPreventive careClinical trialsOutcome measuresThird visitPatientsPlace of residenceResistance InterventionSecondary analysisYears of participationVisitsAdherenceGeneralizability of resultsTrialsRural areasTherapyDrugsRegression modelsRecruitment sites
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 cessationPioglitazone and cardiovascular risk reduction
Perdigoto AL, Young LH, Inzucchi SE. Pioglitazone and cardiovascular risk reduction. Cardiovascular Endocrinology & Metabolism 2017, 6: 55-61. PMID: 31646121, PMCID: PMC6768516, DOI: 10.1097/xce.0000000000000110.Peer-Reviewed Original ResearchInsulin Resistance InterventionCV outcomesInsulin resistanceResistance InterventionImpact of thiazolidinedionesCardiovascular risk reductionGlucose-lowering drugsCardiovascular disease riskInsulin-resistant patientsType 2 diabetesCV complicationsMacrovascular eventsCV riskSecondary preventionResistant patientsStroke patientsStroke trialsPathophysiological abnormalitiesAntihyperglycemic agentsInsulin sensitivityDiabetes managementClinical practiceStroke resultsPatientsDisease risk
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