Evidence map›Paper›PMID 34872617›Full record

ArticleTrials2021

INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial.

Lili Song, Chen Chen, Xiaoying Chen, Yijia Guo, Feifeng Liu, Yapeng Lin, Laurent Billot, Qiang Li, Hueiming Liu, Lei Si and 14 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03790800 (Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 6% 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.

NCT03790800 phase3completednot on this map

Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial

TypeinterventionalSponsorThe George Institute for Global Health, ChinaRan2020 to 2023Enrolled2,425ConditionsStroke, Acute, Cerebrovascular DisordersArmsurapidil
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

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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

24 authors at 17 institutions in 7 countries.

Lili Song *The George Institute China, Peking University Health Science Center, Room 052A, Unit 1, Tayuan Diplomatic Office Building, No. 14 Liangmahe Nan Lu, Chaoyang District, Beijing, China.
Chen Chen *The George Institute China, Peking University Health Science Center, Room 052A, Unit 1, Tayuan Diplomatic Office Building, No. 14 Liangmahe Nan Lu, Chaoyang District, Beijing, China.
Xiaoying ChenThe George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, 1 King Street, PO Box M201, 83-117 Missenden Road, Camperdown, NSW, 2050, Australia.
Yijia GuoDepartment of Neurology, Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College, 278, middle section of Baoguang Avenue, Xindu District, Chengdu City, 610500, Sichuan Province, China.
Feifeng LiuDepartment of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, 1800, Yuntai Road, Shanghai, 200120, China.
Yapeng LinDepartment of Neurology, Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College, 278, middle section of Baoguang Avenue, Xindu District, Chengdu City, 610500, Sichuan Province, China.
Laurent BillotThe George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, 1 King Street, PO Box M201, 83-117 Missenden Road, Camperdown, NSW, 2050, Australia.
Qiang LiThe George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, 1 King Street, PO Box M201, 83-117 Missenden Road, Camperdown, NSW, 2050, Australia.
Hueiming LiuThe George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, 1 King Street, PO Box M201, 83-117 Missenden Road, Camperdown, NSW, 2050, Australia.
Lei SiThe George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, 1 King Street, PO Box M201, 83-117 Missenden Road, Camperdown, NSW, 2050, Australia.
Menglu OuyangThe George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, 1 King Street, PO Box M201, 83-117 Missenden Road, Camperdown, NSW, 2050, Australia.
Hisatomi ArimaThe George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, 1 King Street, PO Box M201, 83-117 Missenden Road, Camperdown, NSW, 2050, Australia.
Philip M BathStroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Gary A FordOxford University Hospitals NHS Foundation Trust and University of Oxford, Oxford, UK.
Thompson RobinsonCollege of Life Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.
Else Charlotte SandsetDepartment of Neurology, Oslo University Hospital, Oslo, Norway.
Jeffrey L SaverUniversity of California, Los Angeles, USA.
Nikola SpriggStroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK.
H Bart van der WorpUniversity Medical Center, Utrecht, the Netherlands.
Chunfang ZhangShanghai Pudong New Area Medical Emergency Center, Shanghai, China.
Jie YangDepartment of Neurology, Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College, 278, middle section of Baoguang Avenue, Xindu District, Chengdu City, 610500, Sichuan Province, China. yangjie1126@163.com.
Gang LiDepartment of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, 1800, Yuntai Road, Shanghai, 200120, China. ligang@tongji.edu.cn.
Craig S AndersonThe George Institute China, Peking University Health Science Center, Room 052A, Unit 1, Tayuan Diplomatic Office Building, No. 14 Liangmahe Nan Lu, Chaoyang District, Beijing, China. canderson@georgeinstitute.org.au.ORCID http://orcid.org/0000-0002-7248-4863
INTERACT4 investigators
The George Institute for Global Health · AUFirst Affiliated Hospital of Chengdu Medical College · CNUniversity of Nottingham · GBSichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital · CNPudong New Area People's Hospital · CNTongji University · CNChengdu Medical College · CNPeking University · CNOslo University Hospital · NOShanghai East Hospital · CNThe University of Sydney · AUUniversity of California, Los Angeles · USFukuoka University · JPUniversity Medical Center Utrecht · NLStiftelsen Norsk Luftambulanse · NOUniversity of Leicester · GBUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4).

methodsA multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression. DISCUSSION: INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke.

trial registrationClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper.

Indexed as

AmbulancesStrokeAntihypertensive AgentsBlood PressureHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeAntihypertensive AgentsAmbulanceBlood pressureClinical trialManagementPre-hospitalStroke

Identifiers

PMID34872617
PMCPMC8646007
OpenAlexW4200543498

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.