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Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable. Should there be a position statement establishing rules for biomarker studies?

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable.Should there be a position statement establishing rules for biomarker studies?John JARCHO, Boston, USA, NEJMRita REDBERG, San Francisco, USA, Arch Intern MedJoseph LOSCALZO, Boston, USA, CirculationJagat NARULA, New York, USA, JACC imagingMona FIUZAT, Durham, USA, JACC-HFJohn CLELAND, Hull, GBR, Former Eur J Heart FailureAbstract : Debate led by Journal Editors: There are too many studies and the quality is variable.Should there be a position statement establishing rules for biomarker studies?The measurement of biomarkers for diagnosis and prognosis ...
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le (14m5s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Resistant hypertension trials: Can renal denervation therapy lower blood pressure?

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Resistant hypertension trials: Can renal denervation therapy lower blood pressure?Speaker: Felix MAHFOUD, Homburg, GERDiscussant: Michel AZIZI, Paris, FRAAbstract : Renal Denervation: Caution is still requiredDespite the availability of multiple classes of orally active antihypertensive treatments, resistant hypertension remains an important public health issue in 2012. The failure of purely pharmacological approaches to treat resistant hypertension has stimulated interest in invasive device-based treatments. A new catheter system using radiofrequency energy has been developed, allowing a percutaneous endovascular approach to renal denervation and providing patients with resistant hypertension with a new therapeutic option. ...
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le (29m25s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : National guideline implementation and national registries.

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : National guideline implementation and national registries• NICESpeaker: Suzanna HARDMAN, London, GBR• German CHF registry: REFLECT –HFSpeaker: Carsten TSCHOEPE, Berlin, GER• Eurobservational, the ESC Heart failure RegistrySpeaker: Aldo MAGGIONI, Florence, ITAAbstract : Multidisciplinary expert workshop: achievements, challenges and barriers to implementations of the ESC 2012 chronic heart failureEurobservational Research Program, the ESC Heart Failure Long Term RegistryChronic Heart Failure (HF) is associated with a high burden of mortality and morbidity, reduced quality of life, and increasing healthcare costs in both US and Europe. Evidence-based medicine represents the most effective means of ensuring ...
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le (1h17m57s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Approvability issues: Pathway to a more global device approval process (Ileana PIÑA)

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012THE DEVICE THERAPY TRIALISTS WORKSHOPChairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USAWebcast: Tariq AHMAD, Durham, USADevice trial methodology, regulatory and implementation issuesAdvances in interventional medical devices are increasingly affecting cardiovascular therapy, just as pharmacological innovation did the generation before. Yet, designing and conducting a device trial is challenging and drug trial designs may not necessarily be applied fully to device trials.➢ Although there is increasing recognition that this development process substantially differs from that for drugs, how much device trial methodology may deviate from drug trial methodology ...
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le (10m8s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Post approval and registry studies (Ileana PIÑA)

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012THE DEVICE THERAPY TRIALISTS WORKSHOPChairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USAWebcast: Tariq AHMAD, Durham, USADevice trial methodology, regulatory and implementation issuesAdvances in interventional medical devices are increasingly affecting cardiovascular therapy, just as pharmacological innovation did the generation before. Yet, designing and conducting a device trial is challenging and drug trial designs may not necessarily be applied fully to device trials.➢ Although there is increasing recognition that this development process substantially differs from that for drugs, how much device trial methodology may deviate from drug trial methodology ...
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le (33m43s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Comparative effectiveness studies (Rita REDBERG)

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012THE DEVICE THERAPY TRIALISTS WORKSHOPChairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USAWebcast: Tariq AHMAD, Durham, USADevice trial methodology, regulatory and implementation issuesAdvances in interventional medical devices are increasingly affecting cardiovascular therapy, just as pharmacological innovation did the generation before. Yet, designing and conducting a device trial is challenging and drug trial designs may not necessarily be applied fully to device trials.➢ Although there is increasing recognition that this development process substantially differs from that for drugs, how much device trial methodology may deviate from drug trial methodology ...
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Conférences

le (36m30s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 :Regulatory viewpoint (Pieter DE GRAEF)

MODIGLIANI Workshop 1 - Friday November 30, 2012 :THE THROMBOSIS TRIALISTS WORKSHOPDOSE AND TARGET PATIENT POPULATIONS ISSUESChairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN, Bucharest, ROMWebcast: Johanne SILVAIN, Paris, FRAThe development of new antithrombotic agents is a challenging area of cardiovascular medicine.These agents generally have a narrow therapeutic margin, and it is often difficult to find the optimal balance between efficacy (reduction of ischemic events) and safety (no excess of bleeding events).➢ Phase II trials are designed to generate signals of safety and efficacy and to select the dose or doses for phase III pivotal trials. However, phase II data ...
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le (27m43s)

Commencements de l’écriture et impacts civilisationnels - Chapitre 1

Commencements de l’écriture et impacts civilisationnels constitue le premier chapitre de la Grande Leçon Jack Goody et l’empire de la littératie.Lorsque le Professeur Jack Goody évoque les modes de communication différenciés que sont pour l’anthropologue l’oralité et l’écriture, il entend, sans accréditer l‘idée d’un « Grand partage » oral/écrit, mettre en évidence une propriété majeure de l’écriture (son pouvoir cumulatif), là où les productions de la parole se distinguent par leur mouvance.Cette ressource est accessible pour les personnes atteintes de handicaps visuels et auditifs.
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le (34m35s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : The value of repeat events in post discharge hospitalized HF trials (Stuart POCOCK)

MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012:HEART FAILURE TRIALISTS WORKSHOPLEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALSChairpersons: Alexandre MEBAZAA, Paris, FRA - Christopher O’CONNOR, Durham, USAWebcast: Daniela DOBRE, Nancy, FRADecreasing the very high mortality and rate of re-hospitalization associated with acute worsening HF is one of the most important unmet needs in cardiovascular medicine. Despite positive signals in Phase II studies, no drug has proven to reduce the appallingly high mortality or readmission rates. The reasons for these ‘failed’ trials are multiple, including the adequacy of candidate drugs, dosing, patient selection and disease ...
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le (16m50s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 5 : Identifying new targets: Monoclonal Antibody Inhibitor of PCSK9 (Wolfgang KOENIG)

MODIGLIANI Workshop 5 - Saturday December 1st, 2012THE ATHEROSCLEROSIS TRIALISTS FORUMChairpersons: Wolfgang KOENIG, Ulm, GER - Anthony WIERZBICKI, London, GBRWebcast: Tabassome SIMON, Paris, FRAWill new compounds be able to reduce the residual risk in high risk patients when treatment targets based on new ESC guidelines have been achieved (e.g. LDL-C < 70mg/dl)?Despite widespread early intervention in acute coronary syndromes and complete revascularization of stenotic lesions complemented by aggressive polypharmacotherapy, still a high percentage of patients develop a secondary event.This has been shown in various registries and recent data from the GRACE registry have suggested that we grossly underestimate long-term risk ...
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