Evidence map›Paper›PMID 29363651›Full record

ArticleChinese medical journal2018

Rationale and Study Design for a Single-Arm Phase IIa Study Investigating Feasibility of Preventing Ischemic Cerebrovascular Events in High-Risk Patients with Acute Non-disabling Ischemic Cerebrovascular Events Using Remote Ischemic Conditioning.

Shi-Meng Liu, Wen-Le Zhao, Hai-Qing Song, Ran Meng, Si-Jie Li, Chang-Hong Ren, Bruce Ovbiagele, Xun-Ming Ji, Wu-Wei Feng

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Chinese medical journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03004820 (Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack -A Single-arm Futility Study), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 41% of its field
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.

NCT03004820 nacompletednot on this map

Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack -A Single-arm Futility Study

TypeinterventionalSponsorCapital Medical UniversityRan2016 to 2017Enrolled167ConditionsTransient Ischemic Attack, Non-disabling StrokeArmsRemote Ischemic Conditioning
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
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

9 authors at 2 institutions in 2 countries.

Shi-Meng LiuDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Wen-Le ZhaoDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC 29403, USA.
Hai-Qing SongDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Ran MengDepartment of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Si-Jie LiBeijing Key Laboratory of Hypoxia Conditioning Translational Medicine, Beijing 100053, China.
Chang-Hong RenBeijing Key Laboratory of Hypoxia Conditioning Translational Medicine, Beijing 100053, China.
Bruce OvbiageleDepartment of Neurology, Medical University of South Carolina, Charleston, SC 29403, USA.
Xun-Ming JiDepartment of Neurology, Xuanwu Hospital, Capital Medical University; Beijing Key Laboratory of Hypoxia Conditioning Translational Medicine, Beijing 100053, China.
Wu-Wei FengDepartment of Neurology, Medical University of South Carolina, Charleston, SC 29403, USA.
Capital Medical University · CNMedical University of South Carolina · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute minor ischemic stroke (AMIS) or transient ischemic attack (TIA) is a common cerebrovascular event with a considerable high recurrence. Prior research demonstrated the effectiveness of regular long-term remote ischemic conditioning (RIC) in secondary stroke prevention in patients with intracranial stenosis. We hypothesized that RIC can serve as an effective adjunctive therapy to pharmacotherapy in preventing ischemic events in patients with AMIS/TIA. This study aimed to investigate the feasibility, safety, and preliminary efficacy of daily RIC in inhibiting cerebrovascular/cardiovascular events after AMIS/TIA.

methodsThis is a single-arm, open-label, multicenter Phase IIa futility study with a sample size of 165. Patients with AMIS/TIA receive RIC as an additional therapy to secondary stroke prevention regimen. RIC consists of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuffs on bilateral upper limbs twice a day for 90 days. The antiplatelet strategy is based on individual physician's best practice: aspirin alone, clopidogrel alone, or combination of aspirin and clopidogrel. We will assess the recurrence rate of ischemic stroke/TIA within 3 months as the primary outcomes.

conclusionsThe data gathered from the study will be used to determine whether a further large-scale, multicenter randomized controlled Phase II trial is warranted in patients with AMIS/TIA.

trial registrationClinicalTrials.gov, NCT03004820; https://www.clinicaltrials.gov/ct2/show/NCT03004820.

Indexed as

Ischemic PreconditioningAdolescentAdultAgedAged, 80 and overAspirinCardiovascular DiseasesClinical Trials, Phase II as TopicClopidogrelDrug Therapy, CombinationFeasibility StudiesFemaleHumansIschemic Attack, TransientMaleMedical FutilityAspirinClopidogrel

Identifiers

PMID29363651
PMCPMC5798057
OpenAlexW2790281180

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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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.