2001
An anti-CD11/CD18 monoclonal antibody in patients with acute myocardial infarction having percutaneous transluminal coronary angioplasty (the FESTIVAL study)
Rusnak J, Kopecky S, Clements I, Gibbons R, Holland A, Peterman H, Martin J, Saoud J, Feldman R, Breisblatt W, Simons M, Gessler C, Yu A, Investigators F. An anti-CD11/CD18 monoclonal antibody in patients with acute myocardial infarction having percutaneous transluminal coronary angioplasty (the FESTIVAL study). The American Journal Of Cardiology 2001, 88: 482-487. PMID: 11524054, DOI: 10.1016/s0002-9149(01)01723-4.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngioplasty, Balloon, CoronaryAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedChi-Square DistributionCombined Modality TherapyCoronary AngiographyDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleElectrocardiographyFemaleFollow-Up StudiesHumansInfusions, IntravenousMaleMiddle AgedMyocardial InfarctionNeuroprotective AgentsPilot ProjectsProbabilitySensitivity and SpecificitySeverity of Illness IndexStatistics, NonparametricSurvival RateTomography, Emission-Computed, Single-PhotonTreatment OutcomeConceptsPercutaneous transluminal coronary angioplastyAcute myocardial infarctionIntercellular adhesion molecule-1Hu23F2GTransluminal coronary angioplastyCD11/CD18Monoclonal antibodiesCoronary angioplastyMyocardial infarctionCD11/CD18 monoclonal antibodyMyocardial single photon emissionInitial clinical safetySubsequent cardiac interventionsST-segment elevationHumanized monoclonal antibodyActivation of neutrophilsAdhesion molecule-1CD18 monoclonal antibodySignificant differencesG treatment groupsNear-baseline valuesSingle photon emissionAdverse eventsCoronary reperfusionInflammatory mediatorsPharmacokinetics and Pharmacodynamics of Recombinant FGF‐2 in a Phase I Trial in Coronary Artery Disease
Bush M, Samara E, Whitehouse MJ, Yoshizawa C, Novicki D, Pike M, Laham R, Simons M, Chronos N. Pharmacokinetics and Pharmacodynamics of Recombinant FGF‐2 in a Phase I Trial in Coronary Artery Disease. The Journal Of Clinical Pharmacology 2001, 41: 378-385. PMID: 11304894, DOI: 10.1177/00912700122010230.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overArea Under CurveCoronary DiseaseEnzyme-Linked Immunosorbent AssayFemaleFibroblast Growth Factor 2Follow-Up StudiesHemodynamicsHeparinHumansInfusions, IntravenousMaleMaximum Tolerated DoseMetabolic Clearance RateMiddle AgedRecombinant ProteinsRegression AnalysisTime FactorsConceptsRecombinant FGF-2Coronary artery diseasePhase I trialFibroblast growth factor-2Artery diseaseI trialSystemic exposureSevere coronary artery diseaseTerminal elimination t1/2Peak plasma concentrationConcentration-time curveMultiple animal modelsDose-response relationshipAcute hemodynamicsGrowth factor 2Chronic ischemiaElimination t1/2Intravenous infusionSingle doseLinear pharmacokineticsDistribution t1/2Plasma concentrationsIntravenous administrationBiphasic eliminationSlow clearance
1999
Local Perivascular Delivery of Basic Fibroblast Growth Factor in Patients Undergoing Coronary Bypass Surgery
Laham R, Sellke F, Edelman E, Pearlman J, Ware J, Brown D, Gold J, Simons M. Local Perivascular Delivery of Basic Fibroblast Growth Factor in Patients Undergoing Coronary Bypass Surgery. Circulation 1999, 100: 1865-1871. PMID: 10545430, DOI: 10.1161/01.cir.100.18.1865.Peer-Reviewed Original ResearchMeSH KeywordsAlginatesCoronary Artery BypassCoronary VesselsDelayed-Action PreparationsDouble-Blind MethodDrug CarriersDrug CompoundingDrug ImplantsFemaleFibroblast Growth Factor 2Follow-Up StudiesGlucuronic AcidHeparinHexuronic AcidsHumansMaleMiddle AgedPatient SelectionPlacebosRecombinant ProteinsConceptsBasic fibroblast growth factorBFGF groupFibroblast growth factorTreatment-related adverse eventsQ-wave myocardial infarctionGrowth factorLocal perivascular deliverySerum bFGF levelsPlacebo-controlled studyCoronary bypass surgerySubset of patientsMode of therapyMagnetic resonance assessmentPromising treatment strategyNuclear perfusionOperative deathsRecurrent anginaStandard revascularizationNew blood vesselsPlacebo groupRepeat revascularizationAdverse eventsBypass surgeryControl patientsPerivascular delivery
1998
Therapeutic Angiogenesis With Basic Fibroblast Growth Factor: Technique and Early Results
Sellke F, Laham R, Edelman E, Pearlman J, Simons M. Therapeutic Angiogenesis With Basic Fibroblast Growth Factor: Technique and Early Results. The Annals Of Thoracic Surgery 1998, 65: 1540-1544. PMID: 9647055, DOI: 10.1016/s0003-4975(98)00340-3.Peer-Reviewed Original ResearchMeSH KeywordsAgedAlginatesAngina PectorisCollateral CirculationCoronary Artery BypassCoronary Artery DiseaseCoronary CirculationCoronary VesselsCreatinineDelayed-Action PreparationsDrug CarriersFeasibility StudiesFemaleFibroblast Growth Factor 2Follow-Up StudiesGlucuronic AcidHeparinHexuronic AcidsHumansMaleMiddle AgedMyocardial ContractionMyocardial InfarctionNeovascularization, PhysiologicPericardiumSafetyStroke VolumeSurvival RateConceptsBasic fibroblast growth factorCoronary artery bypassFibroblast growth factorArtery bypassGrowth factorTherapeutic angiogenesisConventional coronary artery bypassBasic fibroblast growth factor (bFGF) administrationSlow-release devicesStress perfusion scansPerioperative myocardial infarctionSerum creatinine levelsDifficult clinical problemFixed perfusion defectsLong-term resultsMyocardial contractile functionGrowth factor administrationOperative mortalityPatent arteriesMyocardial revascularizationCreatinine levelsEjection fractionClinical efficacyHepatic toxicityPerfusion scan
1993
Relation between Activated Smooth-Muscle Cells in Coronary-Artery Lesions and Restenosis after Atherectomy
Simons M, Leclerc G, Safian R, Isner J, Weir L, Baim D. Relation between Activated Smooth-Muscle Cells in Coronary-Artery Lesions and Restenosis after Atherectomy. New England Journal Of Medicine 1993, 328: 608-613. PMID: 8429852, DOI: 10.1056/nejm199303043280903.Peer-Reviewed Original ResearchConceptsSmooth muscle cellsMyosin heavy chainNonmuscle myosin heavy chainRecurrent luminal narrowingCoronary artery lesionsExercise thallium scintigraphyVascular smooth muscle cellsCoronary atherosclerotic plaquesPresence of restenosisHigh-power fieldGroup of lesionsNegative resultsAngiographic followCoronary atherectomyCoronary angioplastyThallium scintigraphyCoronary lesionsLuminal narrowingNeointimal proliferationSubsequent restenosisLate lossLuminal diameterHeavy chainHigh riskAtherectomy