PMID- 19236498
OWN - NLM
STAT- MEDLINE
DCOM- 20090430
LR  - 20161125
IS  - 1747-4949 (Electronic)
IS  - 1747-4930 (Linking)
VI  - 4
IP  - 1
DP  - 2009 Feb
TI  - Safety and dose-escalation study design of Transcranial Ultrasound in Clinical 
      SONolysis for acute ischemic stroke: the TUCSON Trial.
PG  - 42-8
LID - 10.1111/j.1747-4949.2009.00252.x [doi]
AB  - Rationale Transcranial Doppler (TCD) monitoring during intravenous tissue 
      plasminogen activator (i.v.-tPA) infusion increases recanalization rates in acute 
      ischemic stroke. Addition of perflutren-lipid microspheres MRX-801 (microS) may 
      further enhance the process of recanalization. This article describes the design 
      of the Transcranial Ultrasound in Clinical SONolysis (TUCSON) trial. Aims and 
      Design TUCSON is a phase I-II, randomized, placebo-controlled, open-label, 
      safety, dose-escalation clinical trial of microS+TCD ultrasound (sonolysis). 
      Patients with acute ischemic stroke and arterial intracranial occlusions are 
      enrolled within 3 h of symptom onset. All patients receive standard i.v.-tPA and 
      will be randomized to 90 min of continuous 2-MHz TCD+microS or 90 min of 
      saline+brief TCD vessel assessments. The safety profile of four escalating dose 
      tiers will be assessed. Arterial occlusions and recanalization are defined with 
      the Thrombolysis in Brain Ischemia flow grades. Study Outcomes Safety is 
      determined by the rates of symptomatic intracerebral hemorrhage within 36 h. 
      Neurological deficits and outcomes are measured with the National Institute of 
      Health Stroke Scale and modified Rankin Scale (mRS). The signal-of-efficacy is 
      determined by rates of recanalization, dramatic or early clinical recovery within 
      2 h, clinical recovery at 24-36 h and independent outcome (mRS 0-2) at 90 days.
FAU - Barreto, Andrew D
AU  - Barreto AD
AD  - Department of Neurology, University of Texas-Houston Stroke Team, Houston, TX, 
      USA.
FAU - Sharma, Vijay K
AU  - Sharma VK
FAU - Lao, Annabelle Y
AU  - Lao AY
FAU - Schellinger, Peter D
AU  - Schellinger PD
FAU - Amarenco, Pierre
AU  - Amarenco P
FAU - Sierzenski, Paul
AU  - Sierzenski P
FAU - Alexandrov, Andrei V
AU  - Alexandrov AV
FAU - Molina, Carlos A
AU  - Molina CA
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Int J Stroke
JT  - International journal of stroke : official journal of the International Stroke 
      Society
JID - 101274068
RN  - 0 (Contrast Media)
RN  - 0 (Fibrinolytic Agents)
RN  - 0 (Fluorocarbons)
RN  - CK0N3WH0SR (perflutren)
RN  - EC 3.4.21.68 (Tissue Plasminogen Activator)
SB  - IM
MH  - Contrast Media/*administration & dosage
MH  - Dose-Response Relationship, Drug
MH  - Fibrinolytic Agents/administration & dosage
MH  - Fluorocarbons/*administration & dosage
MH  - Humans
MH  - Infusions, Intravenous
MH  - Microspheres
MH  - Recovery of Function
MH  - *Research Design
MH  - Stroke/*diagnostic imaging/therapy
MH  - Tissue Plasminogen Activator/administration & dosage
MH  - Ultrasonography, Doppler, Transcranial/*methods
EDAT- 2009/02/25 09:00
MHDA- 2009/05/01 09:00
CRDT- 2009/02/25 09:00
PHST- 2009/02/25 09:00 [entrez]
PHST- 2009/02/25 09:00 [pubmed]
PHST- 2009/05/01 09:00 [medline]
AID - IJS252 [pii]
AID - 10.1111/j.1747-4949.2009.00252.x [doi]
PST - ppublish
SO  - Int J Stroke. 2009 Feb;4(1):42-8. doi: 10.1111/j.1747-4949.2009.00252.x.