A Pilot Randomized Clinical Safety Study of Sonothrombolysis
Augmentation With Ultrasound Activated Perflutren Lipid
Microspheres for Acute Ischemic Stroke

J 2008

A Pilot Randomized Clinical Safety Study of Sonothrombolysis Augmentation With Ultrasound Activated Perflutren Lipid Microspheres for Acute Ischemic Stroke

ALEXANDROV, Andrei, Robert MIKULÍK, Marc RIBO, Vijay SHARMA, Annabelle LAO et. al.

Základní údaje

Originální název

A Pilot Randomized Clinical Safety Study of Sonothrombolysis Augmentation With Ultrasound Activated Perflutren Lipid Microspheres for Acute Ischemic Stroke

Název česky

Pilotni randomizovana studie na bezpecnost sonotrombolyzou aktivovanych perflutrenovych mikrosfer u pacientu s akutnim mozkovym infarktem

Autoři

ALEXANDROV, Andrei (840 Spojené státy), Robert MIKULÍK (203 Česká republika, garant, domácí), Marc RIBO (724 Španělsko), Vijay SHARMA (702 Singapur), Annabelle LAO (840 Spojené státy), Georgious TSIVGOULIS (300 Řecko), Rebecca SUGG (840 Spojené státy), Andrew BARETTO (840 Spojené státy), Paul SIERZENSKI (840 Spojené státy), Marc MALKOFF (840 Spojené státy) a James GROTTA (840 Spojené státy)

Vydání

Stroke : a journal of cerebral circulation, Dallas, American Heart Association, 2008, 0039-2499

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30000 3. Medical and Health Sciences

Stát vydavatele

Česká republika

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 6.499

Kód RIV

RIV/00216224:14110/08:00050977

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1161/STROKEAHA.107.505727

UT WoS

000255393100012

Klíčová slova anglicky

microspheres; thrombolysis; stroke; occlusion; transcranial Doppler

Štítky

Microspheres, occlusion, Stroke, thrombolysis, transcranial Doppler

Příznaky

Mezinárodní význam

Změněno: 20. 4. 2012 10:43, Mgr. Michal Petr

Anotace

ORIG CZ

V originále

Background and Purpose: Ultrasound transiently expands perflutren lipid microspheres (microspheres), transmitting energy momentum to surrounding fluids. We report a pilot safety/feasibility study of ultrasound-activated microspheres with systemic tissue plasminogen activator (tPA). Methods: Stroke subjects treated within 3 hours had abnormal Thrombolysis in Brain Ischemia (TIBI) residual flow grades 0 to 3 before tPA on transcranial Doppler (TCD). Randomization included Controls (tPA plus TCD) or Target (tPA plus TCD plus 2.8 mL microspheres). The primary safety end point was symptomatic intracranial hemorrhage (sICH) with worsening by 4 or more NIHSS points within 72 hours. Results: Fifteen subjects were randomized 3:1 to Target, n=12 or Control, n=3. After treatment, asymptomatic ICH occurred in 3 Target and 1 Control, and sICH was not seen in any study subject. Microspheres reached MCA occlusions in all Target subjects at velocities higher than surrounding residual red blood cell flow: 39.8 plus minus 11.3 vs 28.8 plus minus 13.8 cm/s,P=0.001. In 75% of subjects, microspheres permeated to areas with no pretreatment residual flow, and in 83% residual flow velocity improved at a median of 30 minutes from start of microspheres infusion (range 30 s to 120 minutes) by a median of 17 cm/s (118% above pretreatment values). To provide perspective, current study recanalization rates were compared with the tPA control arm of the CLOTBUST trial: complete recanalization 50% versus 18%, partial 33% versus 33%, none 17% versus 49%, P=0.028. At 2 hours, sustained complete recanalization was 42% versus 13%, P=0.003, and NIHSS scores 0 to 3 were reached by 17% versus 8%, P=0.456. Conclusions: Perflutren microspheres reached and permeated beyond intracranial occlusions with no increase in sICH after systemic thrombolysis suggesting feasibility of further microspheres dose escalation studies and development of drug delivery to tissues with compromised perfusion.

Česky

Tato pilotni randomizovana studie prokazala bezpecnost sonotrombolyzou aktivovanych perflutrenovych mikrosfer u pacientu s akutnim mozkovym infarktem

Citovat

ALEXANDROV, Andrei, Robert MIKULÍK, Marc RIBO, Vijay SHARMA, Annabelle LAO, Georgious TSIVGOULIS, Rebecca SUGG, Andrew BARETTO, Paul SIERZENSKI, Marc MALKOFF a James GROTTA. A Pilot Randomized Clinical Safety Study of Sonothrombolysis Augmentation With Ultrasound Activated Perflutren Lipid Microspheres for Acute Ischemic Stroke. Stroke : a journal of cerebral circulation. Dallas: American Heart Association, 2008, roč. 39, č. 5, s. 1464-1469. ISSN 0039-2499. Dostupné z: https://dx.doi.org/10.1161/STROKEAHA.107.505727.

@article{768463,
   author = {Alexandrov, Andrei and Mikulík, Robert and Ribo, Marc and Sharma, Vijay and Lao, Annabelle and Tsivgoulis, Georgious and Sugg, Rebecca and Baretto, Andrew and Sierzenski, Paul and Malkoff, Marc and Grotta, James},
   article_location = {Dallas},
   article_number = {5},
   doi = {http://dx.doi.org/10.1161/STROKEAHA.107.505727},
   keywords = {microspheres; thrombolysis; stroke; occlusion; transcranial Doppler},
   language = {eng},
   issn = {0039-2499},
   journal = {Stroke : a journal of cerebral circulation},
   title = {A Pilot Randomized Clinical Safety Study of Sonothrombolysis Augmentation With Ultrasound Activated Perflutren Lipid Microspheres for Acute Ischemic Stroke},
   volume = {39},
   year = {2008}
}

TY  - JOUR
ID  - 768463
AU  - Alexandrov, Andrei - Mikulík, Robert - Ribo, Marc - Sharma, Vijay - Lao, Annabelle - Tsivgoulis, Georgious - Sugg, Rebecca - Baretto, Andrew - Sierzenski, Paul - Malkoff, Marc - Grotta, James
PY  - 2008
TI  - A Pilot Randomized Clinical Safety Study of Sonothrombolysis Augmentation With Ultrasound Activated Perflutren Lipid Microspheres for Acute Ischemic Stroke
JF  - Stroke : a journal of cerebral circulation
VL  - 39
IS  - 5
SP  - 1464-1469
EP  - 1464-1469
PB  - American Heart Association
SN  - 00392499
KW  - microspheres
KW  - thrombolysis
KW  - stroke
KW  - occlusion
KW  - transcranial Doppler
N2  - Background and Purpose: Ultrasound transiently expands perflutren lipid microspheres (microspheres), transmitting energy momentum to surrounding fluids. We report a pilot safety/feasibility study of ultrasound-activated microspheres with systemic tissue plasminogen activator (tPA). Methods: Stroke subjects treated within 3 hours had abnormal Thrombolysis in Brain Ischemia (TIBI) residual flow grades 0 to 3 before tPA on transcranial Doppler (TCD). Randomization included Controls (tPA plus TCD) or Target (tPA plus TCD plus 2.8 mL microspheres). The primary safety end point was symptomatic intracranial hemorrhage (sICH) with worsening by 4 or more NIHSS points within 72 hours. Results: Fifteen subjects were randomized 3:1 to Target, n=12 or Control, n=3. After treatment, asymptomatic ICH occurred in 3 Target and 1 Control, and sICH was not seen in any study subject. Microspheres reached MCA occlusions in all Target subjects at velocities higher than surrounding residual red blood cell flow: 39.8 plus minus 11.3 vs 28.8 plus minus 13.8 cm/s,P=0.001. In 75% of subjects, microspheres permeated to areas with no pretreatment residual flow, and in 83% residual flow velocity improved at a median of 30 minutes from start of microspheres infusion (range 30 s to 120 minutes) by a median of 17 cm/s (118% above pretreatment values). To provide perspective, current study recanalization rates were compared with the tPA control arm of the CLOTBUST trial: complete recanalization 50% versus 18%, partial 33% versus 33%, none 17% versus 49%, P=0.028. At 2 hours, sustained complete recanalization was 42% versus 13%, P=0.003, and NIHSS scores 0 to 3 were reached by 17% versus 8%, P=0.456. Conclusions: Perflutren microspheres reached and permeated beyond intracranial occlusions with no increase in sICH after systemic thrombolysis suggesting feasibility of further microspheres dose escalation studies and development of drug delivery to tissues with compromised perfusion.
ER  -

ALEXANDROV, Andrei, Robert MIKULÍK, Marc RIBO, Vijay SHARMA, Annabelle LAO, Georgious TSIVGOULIS, Rebecca SUGG, Andrew BARETTO, Paul SIERZENSKI, Marc MALKOFF a James GROTTA. A Pilot Randomized Clinical Safety Study of Sonothrombolysis Augmentation With Ultrasound Activated Perflutren Lipid Microspheres for Acute Ischemic Stroke. \textit{Stroke : a journal of cerebral circulation}. Dallas: American Heart Association, 2008, roč.~39, č.~5, s.~1464-1469. ISSN~0039-2499. Dostupné z: https://dx.doi.org/10.1161/STROKEAHA.107.505727.

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