Document Detail


Lack of clinical significance of early ischemic changes on computed tomography in acute stroke.
MedLine Citation:
PMID:  11735758     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 (rho = 0.23; P<.001) and time from stroke onset to baseline CT scan (rho = 0.11; P =.007). After adjusting for baseline variables, there was no EIC x 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.
Authors:
S C Patel; S R Levine; B C Tilley; J C Grotta; M Lu; M Frankel; E C Haley; T G Brott; J P Broderick; S Horowitz; P D Lyden; C A Lewandowski; J R Marler; K M Welch;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA     Volume:  286     ISSN:  0098-7484     ISO Abbreviation:  JAMA     Publication Date:  2001 Dec 
Date Detail:
Created Date:  2001-12-12     Completed Date:  2001-12-28     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2830-8     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
Aged
Brain Ischemia / radiography*
Humans
Intracranial Hemorrhages / radiography
Logistic Models
Middle Aged
Plasminogen Activators / therapeutic use*
Poisson Distribution
Recombinant Proteins
Risk
Severity of Illness Index
Stroke / drug therapy*,  physiopathology,  radiography*
Survival Analysis
Time Factors
Tissue Plasminogen Activator / therapeutic use*
Tomography, X-Ray Computed
Treatment Outcome
Chemical
Reg. No./Substance:
0/Recombinant Proteins; EC 3.4.21.-/Plasminogen Activators; EC 3.4.21.68/Tissue Plasminogen Activator
Comments/Corrections
Comment In:
JAMA. 2002 May 8;287(18):2361-2; author reply 2362   [PMID:  11988052 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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