Evidence map›Paper›PMID 38134268›Full record

Trial reportStroke2024

Trial Readiness of Cavernous Malformations With Symptomatic Hemorrhage, Part I: Event Rates and Clinical Outcome.

Kelly D Flemming, Helen Kim, Stephanie Hage, Jay Mandrekar, Serena Kinkade, Romuald Girard, Michel Torbey, Judy Huang, John Huston, Yunhong Shu and 22 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Stroke, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03652181 (CASH), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03652181 completednot on this map

CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness

TypeobservationalSponsorUniversity of ChicagoRan2018 to 2022Enrolled123ConditionsCCM, Cavernoma, Cerebral Cavernous Malformation, Cerebral Cavernous Malformations 1
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Trial
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  5. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors.

Kelly D FlemmingDepartment of Neurology (K.D.F.), Mayo Clinic, Rochester, MN.ORCID 0000-0001-6021-1190
Helen KimCenter for Cerebrovascular Research, Department of Anesthesiology and Perioperative Care (H.K.), University of California San Francisco.ORCID 0000-0002-1937-354X
Stephanie HageNeurovascular Surgery Program, Department of Neurological Surgery, University of Chicago Medicine and Biological Sciences, IL (S.H., S.K., R.G., J.L., A.S., R.J.A.-F., R.S., I.A.).ORCID 0000-0002-8168-4621
Jay MandrekarDepartment of Biostatistics (J.M.), Mayo Clinic, Rochester, MN.
Serena KinkadeNeurovascular Surgery Program, Department of Neurological Surgery, University of Chicago Medicine and Biological Sciences, IL (S.H., S.K., R.G., J.L., A.S., R.J.A.-F., R.S., I.A.).
Romuald GirardNeurovascular Surgery Program, Department of Neurological Surgery, University of Chicago Medicine and Biological Sciences, IL (S.H., S.K., R.G., J.L., A.S., R.J.A.-F., R.S., I.A.).
Michel TorbeyDepartment of Neurology (M.T.), University of New Mexico, Albuquerque.ORCID 0000-0001-8187-9683
Judy HuangDepartment of Neurosurgery (J. Huang, J.F.), Johns Hopkins University Medical Institutions, Baltimore, MD.ORCID 0000-0002-0675-1935
John HustonDepartment of Radiology (J. Huston, Y.S.), Mayo Clinic, Rochester, MN.ORCID 0000-0003-0584-9460
Yunhong ShuDepartment of Radiology (J. Huston, Y.S.), Mayo Clinic, Rochester, MN.ORCID 0000-0002-7521-9088
Giuseppe LanzinoDepartment of Neurosurgery (G.L.), Mayo Clinic, Rochester, MN.ORCID 0000-0003-1479-465X
Reed SelwynNeurovascular Surgery Program, Department of Neurological Surgery, University of Chicago Medicine and Biological Sciences, IL (S.H., S.K., R.G., J.L., A.S., R.J.A.-F., R.S., I.A.).ORCID 0000-0003-4547-8342
Blaine HartDepartment of Radiology (R.S., B.H., M.M.), University of New Mexico, Albuquerque.ORCID 0000-0001-5207-1087
Marc MabrayDepartment of Radiology (R.S., B.H., M.M.), University of New Mexico, Albuquerque.ORCID 0000-0001-7355-6833
James FeghaliDepartment of Neurosurgery (J. Huang, J.F.), Johns Hopkins University Medical Institutions, Baltimore, MD.ORCID 0000-0001-7168-4751
Haris I SairDepartment of Radiology, Johns Hopkins University, Baltimore, MD (H.I.S.).
Jared NarvidDepartment of Radiology and Biomedical Imaging (J.N., J.M.L.), University of California San Francisco.ORCID 0000-0002-2887-4231
Janine M LupoDepartment of Radiology and Biomedical Imaging (J.N., J.M.L.), University of California San Francisco.
Justine LeeNeurovascular Surgery Program, Department of Neurological Surgery, University of Chicago Medicine and Biological Sciences, IL (S.H., S.K., R.G., J.L., A.S., R.J.A.-F., R.S., I.A.).
Agnieszka StadnikNeurovascular Surgery Program, Department of Neurological Surgery, University of Chicago Medicine and Biological Sciences, IL (S.H., S.K., R.G., J.L., A.S., R.J.A.-F., R.S., I.A.).
Roberto J Alcazar-FelixNeurovascular Surgery Program, Department of Neurological Surgery, University of Chicago Medicine and Biological Sciences, IL (S.H., S.K., R.G., J.L., A.S., R.J.A.-F., R.S., I.A.).ORCID 0000-0003-1214-5576
Karen LaneBrain Injury Outcomes Unit, Department of Neurology (K.L., N.M., K.T., N.O., Y.W., R.T., D.H.), Johns Hopkins University Medical Institutions, Baltimore, MD.ORCID 0000-0002-7529-0714
Nichole McBeeBrain Injury Outcomes Unit, Department of Neurology (K.L., N.M., K.T., N.O., Y.W., R.T., D.H.), Johns Hopkins University Medical Institutions, Baltimore, MD.
Kevin TreineBrain Injury Outcomes Unit, Department of Neurology (K.L., N.M., K.T., N.O., Y.W., R.T., D.H.), Johns Hopkins University Medical Institutions, Baltimore, MD.
Noeleen OstapkovichBrain Injury Outcomes Unit, Department of Neurology (K.L., N.M., K.T., N.O., Y.W., R.T., D.H.), Johns Hopkins University Medical Institutions, Baltimore, MD.ORCID 0000-0002-6465-2345
Ying WangBrain Injury Outcomes Unit, Department of Neurology (K.L., N.M., K.T., N.O., Y.W., R.T., D.H.), Johns Hopkins University Medical Institutions, Baltimore, MD.
Richard ThompsonBrain Injury Outcomes Unit, Department of Neurology (K.L., N.M., K.T., N.O., Y.W., R.T., D.H.), Johns Hopkins University Medical Institutions, Baltimore, MD.
James I KoenigNational Institute of Neurological Disorders and Stroke, Bethesda, MD (J.I.K.).ORCID 0000-0003-1930-6870
Timothy CarrollDepartment of Diagnostic Radiology, The University of Chicago Medicine and Biological Sciences, IL (T.C.).ORCID 0000-0003-2113-6284
Daniel HanleyBrain Injury Outcomes Unit, Department of Neurology (K.L., N.M., K.T., N.O., Y.W., R.T., D.H.), Johns Hopkins University Medical Institutions, Baltimore, MD.ORCID 0000-0002-9536-4258
Issam AwadNeurovascular Surgery Program, Department of Neurological Surgery, University of Chicago Medicine and Biological Sciences, IL (S.H., S.K., R.G., J.L., A.S., R.J.A.-F., R.S., I.A.).ORCID 0000-0003-1510-602X

Funding

University of New Mexico (UNM) Center for Brain Recovery and RepairP20GM109089 · NIGMS · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI SHUTTLEWORTH, CLAUDE W · 2015 to 2024
$22.7M
Trial Readiness in Cavernous Angiomas with Symptomatic HemorrhageU01NS104157 · NINDS · UNIVERSITY OF CHICAGO · PI AWAD, ISSAM A · 2018 to 2022
$3.8M
NIGMS NIH HHS P20 GM109089NINDS NIH HHS U01 NS104157
6 · The paper itself

Abstract

backgroundCerebral cavernous malformation with symptomatic hemorrhage (SH) are targets for novel therapies. A multisite trial-readiness project (https://www.clinicaltrials.gov; Unique identifier: NCT03652181) aimed to identify clinical, imaging, and functional changes in these patients.

methodsWe enrolled adult cerebral cavernous malformation patients from 5 high-volume centers with SH within the prior year and no planned surgery. In addition to clinical and imaging review, we assessed baseline, 1- and 2-year National Institutes of Health Stroke Scale, modified Rankin Scale, European Quality of Life 5D-3 L, and patient-reported outcome-measurement information system, Version 2.0. SH and asymptomatic change rates were adjudicated. Changes in functional scores were assessed as a marker for hemorrhage.

resultsOne hundred twenty-three, 102, and 69 patients completed baseline, 1- and 2-year clinical assessments, respectively. There were 21 SH during 178.3 patient years of follow-up (11.8% per patient year). At baseline, 62.6% and 95.1% of patients had a modified Rankin Scale score of 1 and National Institutes of Health Stroke Scale score of 0 to 4, respectively, which improved to 75.4% (

conclusionsWe report SH rate, functional, and patient-reported outcomes in trial-eligible cerebral cavernous malformation with SH patients. Functional outcomes and patient-reported outcomes generally improved over 2 years. No score change was highly sensitive or specific for SH and could not be used as a primary end point in a trial.

Indexed as

Hemangioma, Cavernous, Central Nervous SystemStrokeAdultHemorrhageHumansProspective StudiesQuality of LifeTreatment Outcomecavernous angiomaintracranial hemorrhagepatient-reported outcomequality of lifetrial readiness

Identifiers

PMID38134268
PMCPMC10752254

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.