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Andrea Morotti, Javier M Romero, Michael J Jessel, Andrew M Hernandez, Anastasia Vashkevich, Kristin Schwab, Joseph D Burns, Qaisar A Shah, Thomas A Bergman, M Fareed K Suri, Mustapha Ezzeddine, Jawad F Kirmani, Sachin Agarwal, Angela Hays Shapshak, Steven R Messe, Chitra Venkatasubramanian, Katherine Palmieri, Christopher Lewandowski, Tiffany R Chang, Ira Chang, David Z Rose, Wade Smith, Chung Y Hsu, Chun-Lin Liu, Li-Ming Lien, Chen-Yu Hsiao, Toru Iwama, Mohammad Rauf Afzal, Christy Cassarly, Steven M Greenberg, Renee' Hebert Martin, Adnan I Qureshi, Jonathan Rosand, John M Boone, Joshua N Goldstein
PURPOSE: The CT angiography (CTA) spot sign is a strong predictor of hematoma expansion in intracerebral hemorrhage (ICH). However, CTA parameters vary widely across centers and may negatively impact spot sign accuracy in predicting ICH expansion. We developed a CT iodine calibration phantom that was scanned at different institutions in a large multicenter ICH clinical trial to determine the effect of image standardization on spot sign detection and performance. METHODS: A custom phantom containing known concentrations of iodine was designed and scanned using the stroke CT protocol at each institution...
July 20, 2017: Neuroradiology
Andrea Morotti, Gregoire Boulouis, Javier M Romero, H Bart Brouwers, Michael J Jessel, Anastasia Vashkevich, Kristin Schwab, Mohammad Rauf Afzal, Christy Cassarly, Steven M Greenberg, Reneé Hebert Martin, Adnan I Qureshi, Jonathan Rosand, Joshua N Goldstein
OBJECTIVE: To validate various noncontrast CT (NCCT) predictors of hematoma expansion in a large international cohort of ICH patients and investigate whether intensive blood pressure (BP) treatment reduces ICH growth and improves outcome in patients with these markers. METHODS: We analyzed patients enrolled in the Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-II) randomized controlled trial. Participants were assigned to intensive (systolic BP <140 mm Hg) vs standard (systolic BP <180 mm Hg) treatment within 4...
August 8, 2017: Neurology
Andrea Morotti, H Bart Brouwers, Javier M Romero, Michael J Jessel, Anastasia Vashkevich, Kristin Schwab, Mohammad Rauf Afzal, Christy Cassarly, Steven M Greenberg, Renee Hebert Martin, Adnan I Qureshi, Jonathan Rosand, Joshua N Goldstein
Importance: The computed tomographic angiography (CTA) spot sign is associated with intracerebral hemorrhage (ICH) expansion and may mark those patients most likely to benefit from intensive blood pressure (BP) reduction. Objective: To investigate whether the spot sign is associated with ICH expansion across a wide range of centers and whether intensive BP reduction decreases hematoma expansion and improves outcome in patients with ICH and a spot sign. Design, Setting, and Participants: SCORE-IT (Spot Sign Score in Restricting ICH Growth) is a preplanned prospective observational study nested in the Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-II) randomized clinical trial...
August 1, 2017: JAMA Neurology
Shahram Majidi, Jose I Suarez, Adnan I Qureshi
Acute hypertensive response is elevation of systolic blood pressure (SBP) in the first 24 h after symptom onset which is highly prevalent in patients with intracerebral hemorrhage (ICH). Observational studies suggested association between acute hypertensive response and hematoma expansion, peri-hematoma edema and death and disability, and possible reduction in these adverse outcomes with treatment of acute hypertensive response. Recent clinical trials have focused on determining the clinical efficacy of early intensive SBP reduction in ICH patients...
October 2017: Neurocritical Care
Adnan I Qureshi, Yuko Y Palesch, William G Barsan, Daniel F Hanley, Chung Y Hsu, Renee L Martin, Claudia S Moy, Robert Silbergleit, Thorsten Steiner, Jose I Suarez, Kazunori Toyoda, Yongjun Wang, Haruko Yamamoto, Byung-Woo Yoon
BACKGROUND: Limited data are available to guide the choice of a target for the systolic blood-pressure level when treating acute hypertensive response in patients with intracerebral hemorrhage. METHODS: We randomly assigned eligible participants with intracerebral hemorrhage (volume, <60 cm(3)) and a Glasgow Coma Scale (GCS) score of 5 or more (on a scale from 3 to 15, with lower scores indicating worse condition) to a systolic blood-pressure target of 110 to 139 mm Hg (intensive treatment) or a target of 140 to 179 mm Hg (standard treatment) in order to test the superiority of intensive reduction of systolic blood pressure to standard reduction; intravenous nicardipine to lower blood pressure was administered within 4...
September 15, 2016: New England Journal of Medicine
Cléverson O Silva, Jéssica M S Soumaille, Fabiano C Marson, Patrícia S Progiante, Dimitris N Tatakis
AIM: The objective of this prospective study was to assess clinical and patient-centred outcomes of aesthetic crown lengthening surgery for the treatment of altered passive eruption. MATERIALS AND METHODS: Twenty-two patients were treated and followed up for 6 months. The evaluated clinical parameters included, among others, probing depth, clinical attachment level, clinical crown length (CLc ), cemento-enamel junction to alveolar bone crest distance, gingival width (GW) and gingival display (GD)...
December 2015: Journal of Clinical Periodontology
Lisa S Manning, Thompson G Robinson
Although blood pressure (BP) levels may rise in the weeks preceding intracerebral haemorrhage (ICH), in contrast to findings in the ischaemic stroke population, the initial post-ICH BP is often much higher than the last pre-morbid level. Elevated BP is therefore common in acute ICH, often with markedly elevated levels, and is associated with poor outcomes, though the exact pathophysiological mechanisms remain unclear. The Antihypertensive Treatment of Acute Cerebral Haemorrhage (ATACH) trial and the INTEnsive blood pressure Reduction in Acute Cerebral haemorrhage Trial (INTERACT) demonstrated that early and intensive lowering of elevated BP in the acute ICH period is feasible and safe...
2015: Frontiers of Neurology and Neuroscience
P Alan Barber, Timothy J Kleinig
The first Intensive Blood Pressure Reduction in Acute Intracerebral Hemorrhage Trial (INTERACT1) study found that early intensive BP lowering seemed to attenuate haematoma growth when compared with a more conservative guideline based policy. Clinicians were therefore waiting with anticipation for the results of INTERACT2, in which 2839 patients with spontaneous ICH and a systolic BP between 150 and 220 mmHg were randomly assigned to receive intensive anti-hypertensive therapy with a systolic target of <140 mmHg within one hour, or a standard guideline recommended treatment of <180 mmHg...
January 2014: International Journal of Stroke: Official Journal of the International Stroke Society
Syeda L Alqadri, Varun Sreenivasan, Adnan I Qureshi
Acute elevation in blood pressure (acute hypertensive response) is commonly observed in the early period of both ischemic and hemorrhagic stroke. The management of acute hypertensive response depends upon the underlying intracranial pathology. Management of acute hypertensive response has been the focus of many trials and studies such as the SCAST trial, CHHIPS trial, COSSACS trial, INTERACT, and ATACH trial, which are discussed here. However, there were many limitations to these trials including time of presentation, different pathophysiology of ischemic strokes versus hemorrhagic strokes, and patient related factors...
December 2013: Current Cardiology Reports
Adnan I Qureshi, Shahram Majidi, Waqas I Gilani, Yuko Y Palesch, Renee Martin, Jill Novitzke, Salvador Cruz-Flores, Asad Ehtisham, Joshua N Goldstein, Jawad F Kirmani, Haitham M Hussein, M Fareed K Suri, Nauman Tariq
BACKGROUND: We ascertained the occurrence of global cerebral edema manifesting as increased brain volume in subjects with intracerebral hemorrhage (ICH) and explored the relationship between subject characteristics and three month outcomes. METHODS: A post-hoc analysis of a multicenter prospective study that recruited patients with ICH, elevated SBP ≥170 mm Hg, and Glasgow Coma Scale (GCS) score ≥8, who presented within 6 h of symptom onset was performed. Computed tomographic (CT) scans at baseline and 24 h, submitted to a core image laboratory, were analyzed to measure total brain, hematoma, and perihematoma edema volumes from baseline and 24-h CT scans using image analysis software...
June 2014: Neurocritical Care
Haitham M Hussein, Nauman A Tariq, Yuko Y Palesch, Adnan I Qureshi
BACKGROUND AND PURPOSE: The reliability of hematoma volume (HV) measurement using the ABC/2 method in multicenter clinical trials is unknown. We determined the accuracy of ABC/2 method as an on-site test in comparison with the gold standard central HV-assessment and semiautomatic HV-assessment. Method- We analyzed data from an acute intracerebral hemorrhage multicenter clinical trial. HV was measured by site investigators to determine enrollment eligibility (<60 cm(3)) using the ABC/2 method (on-site HV), and independently by the core-imaging laboratory using computer-based analysis (Medical Image Processing, Analysis, and Visualization [MIPAV] HV)...
January 2013: Stroke; a Journal of Cerebral Circulation
Ai Qureshi, B Connelly, Ei Abbott, E Maland, J Kim, J Blake
The availability of internet connectivity and mobile application software used by low-power handheld devices makes smart phones of unique value in time-sensitive clinical trials. Trial-specific applications can be downloaded by investigators from various mobile software distribution platforms or web applications delivered over HTTP. The Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH) II investigators in collaboration with MentorMate released the ATACH-II Patient Recruitment mobile application available on iPhone, Android, and Blackberry in 2011...
August 2012: Journal of Vascular and Interventional Neurology
Jn Goldstein, Hb Brouwers, Jm Romero, K McNamara, K Schwab, Sm Greenberg, J Rosand
INTRODUCTION: The ATACH-II trial is designed to evaluate whether intensive blood pressure reduction can reduce hematoma growth and improve outcome. However, it is difficult to determine, at presentation, which patients are at highest risk of ongoing bleeding, and will receive the most clinical benefit from blood pressure therapy. It may be that improved predictive markers will lead to efficient, personalized selection of optimal therapy. We hypothesize that specific imaging findings on CT angiography (CTA) and MRI will mark those patients who receive the most benefit from intensive blood pressure reduction...
August 2012: Journal of Vascular and Interventional Neurology
Na McBee, Df Hanley, Cs Kase, K Lane, Jr Carhuapoma
In response to growing trends and accepted U.S. Food and Drug Administration (FDA) guidance, the ATACH II trial leadership developed the independent oversight committee (IOC) as a mechanism to adjudicate the trial safety endpoints and to evaluate treatment fidelity and protocol compliance. To accomplish these tasks, the IOC reviews the first three subjects enrolled at each study center and all serious adverse events that occur across all study centers. The IOC makes recommendations to the steering committee regarding the aggregation of, or trend in, adverse events at particular sites and discusses homogeneity, or lack thereof, in the principles and intensity of the overall care...
August 2012: Journal of Vascular and Interventional Neurology
Ai Qureshi, Yy Palesch
The Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II trial is an ongoing multi-center, randomized phase III trial to determine the efficacy of early, intensive, antihypertensive treatment using intravenous (IV) nicardipine initiated within 3 h of onset of intracerebral hemorrhage (ICH). On March 11th, 2012, the National Institutes of Neurological Disorders and Stroke approved recruitment of patients with ICH within 4.5 h of symptom onset. The expansion of recruitment window was based on the recent ATACH-I study analysis that suggests reduction of hematoma expansion and death, and disability in those subjects who were treated within 4...
August 2012: Journal of Vascular and Interventional Neurology
K Toyoda, S Sato, M Koga, H Yamamoto, J Nakagawara, E Furui, Y Shiokawa, Y Hasegawa, S Okuda, N Sakai, K Kimura, Y Okada, S Yoshimura, H Hoshino, Y Uesaka, T Nakashima, Y Itoh, T Ueda, T Nishi, J Gotoh, K Nagatsuka, S Arihiro, T Yamaguchi, K Minematsu
Intracerebral hemorrhage (ICH) is a major cause of morbidity and mortality in Japan. Seventeen Japanese institutions are participating in the Antihypertensive Treatment for Acute Cerebral Hemorrhage (ATACH) II Trial ( no. NCT01176565; UMIN 000006526). This phase III trial is designed to determine the therapeutic benefit of early intensive systolic blood pressure (BP) lowering for acute hypertension in ICH patients. This report explains the long run-up to reach the start of patient registration in ATACH II in Japan, including our preliminary study, a nationwide survey on antihypertensive treatment for acute ICH patients, a multicenter study for hyperacute BP lowering (the SAMURAI-ICH study), revision of the official Japanese label for intravenous nicardipine, and construction of the infrastructure for the trial...
August 2012: Journal of Vascular and Interventional Neurology
Masatoshi Koga, Kazunori Toyoda
Intracerebral hemorrhage (ICH) is a common stroke subtype in Japan. Hypertension is the leading cause. Perindopril Protection Against Recurrent Stroke Study (PROGRESS) revealed that blood pressure (BP) lowering could reduce stroke recurrence by 28% (ICH recurrence by 49%). The guideline for the management of hypertension (JSH2009) recommends BP control of ≤ 140/90 mm Hg for patients with prior stroke. BP is frequently elevated in acute ICH, although BP management strategy is controversial. The guideline from the American Stroke Association suggests if systolic BP (SBP) >180 mm Hg and there is no evidence of elevated intracranial pressure, then consider a modest reduction of BP...
2012: Rinshō Shinkeigaku, Clinical Neurology
Shoichiro Sato, Haruko Yamamoto, Adnan I Qureshi, Yuko Y Palesch, Kazunori Toyoda
The Antihypertensive Treatment for Acute Cerebral Hemorrhage (ATACH)-II Trial ( no. NCT01176565; (UMIN 000006526) is an international, multicenter, randomized, concurrently-controlled, parallel arm, Phase III trial to determine the therapeutic benefit of early intensive systolic blood pressure (SBP) lowering compared with standard SBP lowering for acute hypertension in patients with spontaneous intracerebral hemorrhage (ICH). The Trial is funded by the National Institutes of Health in the United States and led by Dr...
2012: Rinshō Shinkeigaku, Clinical Neurology
Syeda L Alqadri, Adnan I Qureshi
Spontaneous intracerebral hemorrhage (ICH) is intra-parenchymal bleeding that may lead to localized hematoma formation. The hematoma can enlarge over a period of time, and directly contribute to neurological deterioration and death. Several studies have shown a relationship between acute hypertensive response and poor prognosis among patients with ICH; however, it is somewhat unclear whether hematomal expansion, is a cause or a result of elevated blood pressure (BP). Current AHA guidelines state MAP should be maintained <130 mmHg and systolic blood pressure (SBP) <180 mmHg...
August 2012: Current Atherosclerosis Reports
Erin M Grise, Opeolu Adeoye
PURPOSE OF REVIEW: Acute stroke, including the subtypes of ischemic stroke, intracerebral hemorrhage (ICH), and subarachnoid hemorrhage (SAH), typically involves significant fluctuations in blood pressure (BP). Treatment of BP after all stroke types is controversial. In each case, there are theoretical dangers to leaving BP alone as well as altering it artificially. In this article, we review the role of BP in each stroke subtype and the existing evidence for BP optimization. RECENT FINDINGS: Except in patients receiving thrombolytic therapy, there is insufficient evidence to recommend active BP management in ischemic stroke...
April 2012: Current Opinion in Critical Care
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