Lack of Clinical Significance of Early Ischemic Changes on Computed Tomography in Acute Stroke

CONTEXT The prevalence and clinical significance of early ischemic changes (EICs) on baseline computed tomography (CT) scan of the head obtained within 3 hours of ischemic stroke are not established. OBJECTIVE To determine the frequency and significance of EIC on baseline head CT scans in the Nation...

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Veröffentlicht in:JAMA : the journal of the American Medical Association 2001-12, Vol.286 (22), p.2830-2838
Hauptverfasser: Patel, Suresh C, Levine, Steven R, Tilley, Barbara C, Grotta, James C, Lu, Mei, Frankel, Michael, Haley, Jr, E. Clarke, Brott, Thomas G, Broderick, Joseph P, Horowitz, Steven, Lyden, Patrick D, Lewandowski, Christopher A, Marler, John R, Welch, K. M. A, for the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group
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container_issue 22
container_start_page 2830
container_title JAMA : the journal of the American Medical Association
container_volume 286
creator Patel, Suresh C
Levine, Steven R
Tilley, Barbara C
Grotta, James C
Lu, Mei
Frankel, Michael
Haley, Jr, E. Clarke
Brott, Thomas G
Broderick, Joseph P
Horowitz, Steven
Lyden, Patrick D
Lewandowski, Christopher A
Marler, John R
Welch, K. M. A
for the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group
description CONTEXT The prevalence and clinical significance of early ischemic changes (EICs) on baseline computed tomography (CT) scan of the head obtained within 3 hours of ischemic stroke are not established. OBJECTIVE To determine the frequency and significance of EIC on baseline head CT scans in the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA (recombinant tissue plasminogen activator) Stroke Trial. DESIGN AND SETTING The original study, a randomized controlled trial, took place from January 1991 through October 1994 at 43 sites, during which CT images were obtained within 3 hours of symptom onset and prior to the initiation of rt-PA or placebo. For the current analysis, detailed reevaluation was undertaken after October 1994 of all baseline head CT scans with clinical data available pretreatment (blinded to treatment arm). PATIENTS Of 624 patients enrolled in the trial, baseline CT scans were retrieved and reviewed for 616 (99%). MAIN OUTCOME MEASURES Frequency of EICs on baseline CT scans; association of EIC with other baseline variables; effect of EICs on deterioration at 24 hours (≥4 points increase from the baseline National Institutes of Health Stroke Scale [NIHSS] score); clinical outcome (measured by 4 clinical scales) at 3 months, CT lesion volume at 3 months, death at 90 days; and symptomatic intracranial hemorrhage (ICH) within 36 hours of treatment. RESULTS The prevalence of EIC on baseline CT in the combined rt-PA and placebo groups was 31% (n = 194). The EIC was significantly associated with baseline NIHSS score (ρ = 0.23; P
doi_str_mv 10.1001/jama.286.22.2830
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Clarke ; Brott, Thomas G ; Broderick, Joseph P ; Horowitz, Steven ; Lyden, Patrick D ; Lewandowski, Christopher A ; Marler, John R ; Welch, K. M. A ; for the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group</creator><creatorcontrib>Patel, Suresh C ; Levine, Steven R ; Tilley, Barbara C ; Grotta, James C ; Lu, Mei ; Frankel, Michael ; Haley, Jr, E. Clarke ; Brott, Thomas G ; Broderick, Joseph P ; Horowitz, Steven ; Lyden, Patrick D ; Lewandowski, Christopher A ; Marler, John R ; Welch, K. M. A ; for the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group ; National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group</creatorcontrib><description>CONTEXT The prevalence and clinical significance of early ischemic changes (EICs) on baseline computed tomography (CT) scan of the head obtained within 3 hours of ischemic stroke are not established. OBJECTIVE To determine the frequency and significance of EIC on baseline head CT scans in the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA (recombinant tissue plasminogen activator) Stroke Trial. DESIGN AND SETTING The original study, a randomized controlled trial, took place from January 1991 through October 1994 at 43 sites, during which CT images were obtained within 3 hours of symptom onset and prior to the initiation of rt-PA or placebo. For the current analysis, detailed reevaluation was undertaken after October 1994 of all baseline head CT scans with clinical data available pretreatment (blinded to treatment arm). PATIENTS Of 624 patients enrolled in the trial, baseline CT scans were retrieved and reviewed for 616 (99%). MAIN OUTCOME MEASURES Frequency of EICs on baseline CT scans; association of EIC with other baseline variables; effect of EICs on deterioration at 24 hours (≥4 points increase from the baseline National Institutes of Health Stroke Scale [NIHSS] score); clinical outcome (measured by 4 clinical scales) at 3 months, CT lesion volume at 3 months, death at 90 days; and symptomatic intracranial hemorrhage (ICH) within 36 hours of treatment. RESULTS The prevalence of EIC on baseline CT in the combined rt-PA and placebo groups was 31% (n = 194). The EIC was significantly associated with baseline NIHSS score (ρ = 0.23; P&lt;.001) and time from stroke onset to baseline CT scan (ρ = 0.11; P = .007). After adjusting for baseline variables, there was no EIC × treatment interaction detected for any clinical outcome, including deterioration at 24 hours, 4 clinical scales, lesion volume, and death at 90 days (P≥.25), implying that EIC is unlikely to affect response to rt-PA treatment. After adjusting for NIHSS score (an independent predictor of ICH), no EIC association with symptomatic ICH at 36 hours was detected in the group treated with rt-PA (P≥.22). CONCLUSIONS Our analysis suggests that EICs are prevalent within 3 hours of stroke onset and correlate with stroke severity. However, EICs are not independently associated with increased risk of adverse outcome after rt-PA treatment. Patients treated with rt-PA did better whether or not they had EICs, suggesting that EICs on CT scan are not critical to the decision to treat otherwise eligible patients with rt-PA within 3 hours of stroke onset.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.286.22.2830</identifier><identifier>PMID: 11735758</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Aged ; Biological and medical sciences ; Brain Ischemia - diagnostic imaging ; Drug therapy ; Humans ; Intracranial Hemorrhages - diagnostic imaging ; Investigative techniques, diagnostic techniques (general aspects) ; Logistic Models ; Medical sciences ; Middle Aged ; Nervous system ; Neurology ; Plasminogen Activators - therapeutic use ; Poisson Distribution ; Radiodiagnosis. Nmr imagery. Nmr spectrometry ; Recombinant Proteins ; Risk ; Severity of Illness Index ; Stroke ; Stroke - diagnostic imaging ; Stroke - drug therapy ; Stroke - physiopathology ; Survival Analysis ; Time Factors ; Tissue Plasminogen Activator - therapeutic use ; Tomography ; Tomography, X-Ray Computed ; Treatment Outcome ; Vascular diseases and vascular malformations of the nervous system</subject><ispartof>JAMA : the journal of the American Medical Association, 2001-12, Vol.286 (22), p.2830-2838</ispartof><rights>2002 INIST-CNRS</rights><rights>Copyright American Medical Association Dec 12, 2001</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a426t-4bb327c60f62c935f56ee2bc8253a4cb294dc6171cee3d5e1d0b8a1c2cd6921f3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.286.22.2830$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.286.22.2830$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,776,780,3326,27903,27904,76236,76239</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=13410139$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11735758$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Patel, Suresh C</creatorcontrib><creatorcontrib>Levine, Steven R</creatorcontrib><creatorcontrib>Tilley, Barbara C</creatorcontrib><creatorcontrib>Grotta, James C</creatorcontrib><creatorcontrib>Lu, Mei</creatorcontrib><creatorcontrib>Frankel, Michael</creatorcontrib><creatorcontrib>Haley, Jr, E. Clarke</creatorcontrib><creatorcontrib>Brott, Thomas G</creatorcontrib><creatorcontrib>Broderick, Joseph P</creatorcontrib><creatorcontrib>Horowitz, Steven</creatorcontrib><creatorcontrib>Lyden, Patrick D</creatorcontrib><creatorcontrib>Lewandowski, Christopher A</creatorcontrib><creatorcontrib>Marler, John R</creatorcontrib><creatorcontrib>Welch, K. M. A</creatorcontrib><creatorcontrib>for the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group</creatorcontrib><creatorcontrib>National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group</creatorcontrib><title>Lack of Clinical Significance of Early Ischemic Changes on Computed Tomography in Acute Stroke</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>CONTEXT The prevalence and clinical significance of early ischemic changes (EICs) on baseline computed tomography (CT) scan of the head obtained within 3 hours of ischemic stroke are not established. OBJECTIVE To determine the frequency and significance of EIC on baseline head CT scans in the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA (recombinant tissue plasminogen activator) Stroke Trial. DESIGN AND SETTING The original study, a randomized controlled trial, took place from January 1991 through October 1994 at 43 sites, during which CT images were obtained within 3 hours of symptom onset and prior to the initiation of rt-PA or placebo. For the current analysis, detailed reevaluation was undertaken after October 1994 of all baseline head CT scans with clinical data available pretreatment (blinded to treatment arm). PATIENTS Of 624 patients enrolled in the trial, baseline CT scans were retrieved and reviewed for 616 (99%). MAIN OUTCOME MEASURES Frequency of EICs on baseline CT scans; association of EIC with other baseline variables; effect of EICs on deterioration at 24 hours (≥4 points increase from the baseline National Institutes of Health Stroke Scale [NIHSS] score); clinical outcome (measured by 4 clinical scales) at 3 months, CT lesion volume at 3 months, death at 90 days; and symptomatic intracranial hemorrhage (ICH) within 36 hours of treatment. RESULTS The prevalence of EIC on baseline CT in the combined rt-PA and placebo groups was 31% (n = 194). The EIC was significantly associated with baseline NIHSS score (ρ = 0.23; P&lt;.001) and time from stroke onset to baseline CT scan (ρ = 0.11; P = .007). After adjusting for baseline variables, there was no EIC × treatment interaction detected for any clinical outcome, including deterioration at 24 hours, 4 clinical scales, lesion volume, and death at 90 days (P≥.25), implying that EIC is unlikely to affect response to rt-PA treatment. After adjusting for NIHSS score (an independent predictor of ICH), no EIC association with symptomatic ICH at 36 hours was detected in the group treated with rt-PA (P≥.22). CONCLUSIONS Our analysis suggests that EICs are prevalent within 3 hours of stroke onset and correlate with stroke severity. However, EICs are not independently associated with increased risk of adverse outcome after rt-PA treatment. Patients treated with rt-PA did better whether or not they had EICs, suggesting that EICs on CT scan are not critical to the decision to treat otherwise eligible patients with rt-PA within 3 hours of stroke onset.</description><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Brain Ischemia - diagnostic imaging</subject><subject>Drug therapy</subject><subject>Humans</subject><subject>Intracranial Hemorrhages - diagnostic imaging</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Logistic Models</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nervous system</subject><subject>Neurology</subject><subject>Plasminogen Activators - therapeutic use</subject><subject>Poisson Distribution</subject><subject>Radiodiagnosis. Nmr imagery. Nmr spectrometry</subject><subject>Recombinant Proteins</subject><subject>Risk</subject><subject>Severity of Illness Index</subject><subject>Stroke</subject><subject>Stroke - diagnostic imaging</subject><subject>Stroke - drug therapy</subject><subject>Stroke - physiopathology</subject><subject>Survival Analysis</subject><subject>Time Factors</subject><subject>Tissue Plasminogen Activator - therapeutic use</subject><subject>Tomography</subject><subject>Tomography, X-Ray Computed</subject><subject>Treatment Outcome</subject><subject>Vascular diseases and vascular malformations of the nervous system</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0c9LwzAUB_AgipvTu14kCHrrzO-mx1GmDgYeNq-WNE23bG0zm_aw_97IJgMv5vJC3ofA-z4AbjEaY4Tw80bVakykGBMSCkVnYIg5lRHliTwHQ4QSGcVMsgG48n6DwsE0vgQDjGPKYy6H4HOu9Ba6EqaVbaxWFVzYVWPLcG20-WlMVVvt4czrtamthulaNSvjoWtg6upd35kCLl3tVq3arffQNnCiwyNcdK3bmmtwUarKm5tjHYGPl-kyfYvm76-zdDKPFCOii1ieUxJrgUpBdEJ5yYUxJNeScKqYzknCCi1wjLUxtOAGFyiXCmuiC5EQXNIReDr8u2vdV298l9XWa1NVqjGu91lMKCOIkX8hlgwRkfAAH_7AjevbJgyREYwpFywWAd0fUZ_Xpsh2ra1Vu89-8w3g8QiUD-GWbUjV-pOjDIeVJMHdHVxY6KmbMMYF_QagCZEV</recordid><startdate>20011212</startdate><enddate>20011212</enddate><creator>Patel, Suresh C</creator><creator>Levine, Steven R</creator><creator>Tilley, Barbara C</creator><creator>Grotta, James C</creator><creator>Lu, Mei</creator><creator>Frankel, Michael</creator><creator>Haley, Jr, E. Clarke</creator><creator>Brott, Thomas G</creator><creator>Broderick, Joseph P</creator><creator>Horowitz, Steven</creator><creator>Lyden, Patrick D</creator><creator>Lewandowski, Christopher A</creator><creator>Marler, John R</creator><creator>Welch, K. M. A</creator><creator>for the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>20011212</creationdate><title>Lack of Clinical Significance of Early Ischemic Changes on Computed Tomography in Acute Stroke</title><author>Patel, Suresh C ; Levine, Steven R ; Tilley, Barbara C ; Grotta, James C ; Lu, Mei ; Frankel, Michael ; Haley, Jr, E. Clarke ; Brott, Thomas G ; Broderick, Joseph P ; Horowitz, Steven ; Lyden, Patrick D ; Lewandowski, Christopher A ; Marler, John R ; Welch, K. M. 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Nmr spectrometry</topic><topic>Recombinant Proteins</topic><topic>Risk</topic><topic>Severity of Illness Index</topic><topic>Stroke</topic><topic>Stroke - diagnostic imaging</topic><topic>Stroke - drug therapy</topic><topic>Stroke - physiopathology</topic><topic>Survival Analysis</topic><topic>Time Factors</topic><topic>Tissue Plasminogen Activator - therapeutic use</topic><topic>Tomography</topic><topic>Tomography, X-Ray Computed</topic><topic>Treatment Outcome</topic><topic>Vascular diseases and vascular malformations of the nervous system</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Patel, Suresh C</creatorcontrib><creatorcontrib>Levine, Steven R</creatorcontrib><creatorcontrib>Tilley, Barbara C</creatorcontrib><creatorcontrib>Grotta, James C</creatorcontrib><creatorcontrib>Lu, Mei</creatorcontrib><creatorcontrib>Frankel, Michael</creatorcontrib><creatorcontrib>Haley, Jr, E. 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A</creatorcontrib><creatorcontrib>for the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group</creatorcontrib><creatorcontrib>National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium &amp; Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Patel, Suresh C</au><au>Levine, Steven R</au><au>Tilley, Barbara C</au><au>Grotta, James C</au><au>Lu, Mei</au><au>Frankel, Michael</au><au>Haley, Jr, E. Clarke</au><au>Brott, Thomas G</au><au>Broderick, Joseph P</au><au>Horowitz, Steven</au><au>Lyden, Patrick D</au><au>Lewandowski, Christopher A</au><au>Marler, John R</au><au>Welch, K. M. A</au><au>for the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group</au><aucorp>National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Lack of Clinical Significance of Early Ischemic Changes on Computed Tomography in Acute Stroke</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2001-12-12</date><risdate>2001</risdate><volume>286</volume><issue>22</issue><spage>2830</spage><epage>2838</epage><pages>2830-2838</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT The prevalence and clinical significance of early ischemic changes (EICs) on baseline computed tomography (CT) scan of the head obtained within 3 hours of ischemic stroke are not established. OBJECTIVE To determine the frequency and significance of EIC on baseline head CT scans in the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA (recombinant tissue plasminogen activator) Stroke Trial. DESIGN AND SETTING The original study, a randomized controlled trial, took place from January 1991 through October 1994 at 43 sites, during which CT images were obtained within 3 hours of symptom onset and prior to the initiation of rt-PA or placebo. For the current analysis, detailed reevaluation was undertaken after October 1994 of all baseline head CT scans with clinical data available pretreatment (blinded to treatment arm). PATIENTS Of 624 patients enrolled in the trial, baseline CT scans were retrieved and reviewed for 616 (99%). MAIN OUTCOME MEASURES Frequency of EICs on baseline CT scans; association of EIC with other baseline variables; effect of EICs on deterioration at 24 hours (≥4 points increase from the baseline National Institutes of Health Stroke Scale [NIHSS] score); clinical outcome (measured by 4 clinical scales) at 3 months, CT lesion volume at 3 months, death at 90 days; and symptomatic intracranial hemorrhage (ICH) within 36 hours of treatment. RESULTS The prevalence of EIC on baseline CT in the combined rt-PA and placebo groups was 31% (n = 194). The EIC was significantly associated with baseline NIHSS score (ρ = 0.23; P&lt;.001) and time from stroke onset to baseline CT scan (ρ = 0.11; P = .007). After adjusting for baseline variables, there was no EIC × treatment interaction detected for any clinical outcome, including deterioration at 24 hours, 4 clinical scales, lesion volume, and death at 90 days (P≥.25), implying that EIC is unlikely to affect response to rt-PA treatment. After adjusting for NIHSS score (an independent predictor of ICH), no EIC association with symptomatic ICH at 36 hours was detected in the group treated with rt-PA (P≥.22). CONCLUSIONS Our analysis suggests that EICs are prevalent within 3 hours of stroke onset and correlate with stroke severity. However, EICs are not independently associated with increased risk of adverse outcome after rt-PA treatment. Patients treated with rt-PA did better whether or not they had EICs, suggesting that EICs on CT scan are not critical to the decision to treat otherwise eligible patients with rt-PA within 3 hours of stroke onset.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>11735758</pmid><doi>10.1001/jama.286.22.2830</doi><tpages>9</tpages></addata></record>
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subjects Aged
Biological and medical sciences
Brain Ischemia - diagnostic imaging
Drug therapy
Humans
Intracranial Hemorrhages - diagnostic imaging
Investigative techniques, diagnostic techniques (general aspects)
Logistic Models
Medical sciences
Middle Aged
Nervous system
Neurology
Plasminogen Activators - therapeutic use
Poisson Distribution
Radiodiagnosis. Nmr imagery. Nmr spectrometry
Recombinant Proteins
Risk
Severity of Illness Index
Stroke
Stroke - diagnostic imaging
Stroke - drug therapy
Stroke - physiopathology
Survival Analysis
Time Factors
Tissue Plasminogen Activator - therapeutic use
Tomography
Tomography, X-Ray Computed
Treatment Outcome
Vascular diseases and vascular malformations of the nervous system
title Lack of Clinical Significance of Early Ischemic Changes on Computed Tomography in Acute Stroke
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