TeleStroke-Guided Thrombolysis for Acute Ischemic Stroke in Oman

July 19, 2026 updated by: Oman Ministry of Health

Thrombolysis for Acute Ischemic Stroke Facilitated by TeleStroke: Oman TeleStroke Initiative

The goal of this study is to establish and examine the efficacy of using a Telestroke network in Oman to facilitate using emergent thrombolysis for patients with acute ischemic stroke encountered in selected peripheral hospitals. It is proposed to establish a TeleStroke network involving two central hospitals in Muscat linked to three to five peripheral hospitals in Oman which currently have access to CT scans and basic infrastructure for management of AIS patients- but do not have a Neurology service. Selected staff from Internal Medicine/Emergency Medicine departments, Nursing, Technical service and support staffs will be trained in the process of assessment and management of AIS patients including the use of IV alteplase or tenecteplase. They will also be trained in timely access of a Neurologist on call at the central hospital(s) using a TeleStroke network. The Neurologist would conduct a Telestroke based clinical assessment of the AIS patient, review imaging and laboratory results in a timely manner and advice the medical team at the peripheral hospital regarding administration of IV alteplase/tenecteplase. The main purpose of such consultation would be to recognize eligible patients for administration of IV thrombolysis safely at the earliest opportunity within 4.5 hours, leading to increased rates of such thrombolysis with expected improved outcomes. Outcomes would be compared among 100 patients with AIS managed across these 5 hospitals prior to initiation of the practice of thrombolysis and at least 100 patients treated each with IV alteplase using TeleStroke Consultation with Neurologist. Demonstration of efficacy of TeleStroke based stroke thrombolysis would lead to effective implementation of this practice in Oman.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is the second leading cause of death globally and the primary cause of long-term disability. Timely management of acute ischemic stroke (AIS) requires emergent administration of intravenous thrombolytics (alteplase or tenecteplase) within 4.5 hours of symptom onset, often followed by triage for possible thrombectomy. However, many peripheral hospitals, particularly in regions like Oman, lack the specialized neurological expertise necessary for this time-sensitive management.

Telemedicine, specifically 'TeleStroke,' has emerged as a crucial solution in numerous countries and communities to bridge this gap, enabling remote neurological support for acute stroke thrombolysis. The Oman TeleStroke Initiative aims to establish and evaluate the efficacy of such a network.

Study Objectives:

This study aims to:

Establish a TeleStroke 'hub' center within one or two major hospitals in Muscat with existing neurologic services.

Develop 'spoke' TeleStroke centers in five peripheral hospitals (Rustaq, Ibra, Buraimi, Ibri, and Sur) by identifying and engaging multidisciplinary participating teams (Internal Medicine, Emergency Medicine, Imaging, Laboratory, Nursing, Technical support).

Train senior physician-led teams at spoke hospitals in TeleStroke-based acute stroke management protocols, specifically focusing on intravenous thrombolysis.

Educate broader medical and paramedical teams in overall acute stroke management and decision-making processes.

Sequentially initiate acute stroke thrombolysis services at peripheral centers following a stepped-wedge trial model.

Conduct 3-5 mock TeleStroke-based stroke thrombolysis cycles at each peripheral center to ensure readiness and troubleshoot protocols.

Support and monitor 20 stroke care encounters for thrombolysis at each spoke center.

Document demographic data, stroke type and severity (NIH Stroke Scale, GCS), main neurologic deficits, risk factors, discharge outcome (neurologic deficits; NISS; modified Rankin Score), and 3-month outcome for two patient groups at each center: 30 patients receiving conventional management before TeleStroke initiation and 20 patients after TeleStroke-facilitated thrombolysis.

Conduct a comprehensive cost-benefit analysis.

Compare outcomes and cost-benefit between cohorts before and after TeleStroke initiation.

Facilitate handover of the project to a standing committee managed by participating hospitals upon project completion.

Study Design and Setting:

This is an implementation study utilizing a stepped-wedge randomized trial model. The project will establish a TeleStroke network comprising one or two expert 'hub' hospitals in Muscat linked to five 'spoke' hospitals in the periphery (Rustaq, Ibra, Buraimi, Ibri, and Sur). The sequential initiation of thrombolysis services at spoke centers under TeleStroke guidance will allow for observation of conventional management (control phase) followed by the intervention phase at each site.

Intervention and Training:

The intervention involves the implementation of a TeleStroke network and comprehensive training. At peripheral hospitals, 2-3 dedicated senior physicians from Internal Medicine and Emergency Medicine will be trained in acute stroke management, focusing on thrombolytic care. This training will include didactic lectures, case discussions, hands-on sessions (e.g., NIH Stroke Scale administration), CT evaluation in acute stroke, thrombolysis decision-making, post-thrombolysis care, and communication skills. Related medical and paramedical teams (Nursing, Physical Medicine) will also receive training in overall acute stroke and post-stroke patient management. Essential IT infrastructure (computers with audio-video, image/lab upload capabilities) will be provided, and a dedicated computer application for systematic communication and documentation will be adapted. Mock encounters will be practiced at each center to refine protocols and achieve short door-to-needle times.

Key Management Steps:

Eligible patients will undergo a rapid assessment including focused history ("last known to be normal" time), neurological exam (NIHSS, GCS), vital signs, and urgent investigations (blood glucose, CBC, U&E, ECG, CT brain plain, with CTA if available). If eligible for IV alteplase, consent will be obtained, and a TeleStroke consultation with a neurologist will be initiated. The remote neurologist will confirm eligibility, review imaging and labs, confirm consent, recommend the alteplase dose (0.9 mg/kg total, 10% bolus over 2 min, remainder over 1 hour), and guide post-dosing care. Patients will be monitored for BP, sensorium, deficits, and hemorrhage, with repeat CT at 24 hours or earlier if worsening. Patients with poor neurological status or complications may be transferred to a central hospital for expert care. Follow-up will extend to 3 months.

Endpoints of Interest:

Primary Outcomes:

Rate of utilization of IV alteplase thrombolysis for AIS at peripheral hospitals.

3-month clinical outcomes (Good=mRS 0-2; Poor=mRS 3-6) comparing control and rtPA groups.

Rates of intracranial or systemic hemorrhage.

Secondary Outcomes:

Discharge clinical outcomes (Good=mRS 0-2; Poor=mRS 3-6) comparing control and rtPA groups.

Time from patient arrival to initiation of TeleStroke Consult.

Door-to-Needle time for rtPA administration.

Rates of TeleStroke Consultations for acute stroke from peripheral hospitals.

Frequency of patient transfers to central hospitals.

Frequency of ICU admissions required.

Estimated cost of care: Comparison among Controls and rtPA Groups.

Statistical Analysis:

A stepped-wedge randomized model will guide implementation. Data from 30 patients managed conventionally will be documented at each center prior to thrombolysis initiation. After at least 20 thrombolysis encounters per peripheral hospital, overall outcomes will be analyzed. Continuous variables will be summarized using means/SDs or medians/quartiles, and categorical variables using frequencies/percentages. Analyses will be 2-tailed (p<0.05) using SPSS-21. Univariate methods will compare endpoints, and logistic regression will explore factors influencing outcomes. Cost-benefit analysis will compare TeleStroke-based management to conventional methods.

Significance to Oman and Benefits:

This initiative addresses a critical gap in acute ischemic stroke care by extending access to thrombolysis, currently largely inaccessible in many Omani peripheral communities. Successful implementation will align Omani stroke care with current international standards, potentially reducing stroke-related mortality and long-term morbidity. The expected reduction in long-term disability care costs is anticipated to offset program implementation and management expenses. This project will also foster ongoing skilled manpower development in acute care, telemedicine, and TeleStroke technology within Oman. While replicating studies conducted elsewhere, this research is vital to address local limitations such as telecommunications access, technological constraints, and community/hospital acceptability specific to Oman.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18 years. Acute neurologic deficits due to cerebral ischemia/infarction. Clearly defined onset with duration from stroke onset of <4.5 hours. Significant neurological deficit (usually NIHSS score of 4-25).

Exclusion Criteria:

  • CT brain shows showing evidence of intracranial hemorrhage
  • CT brain showing acute or subacute infarct of size about >1/3 Middle Cerebral Artery territory.
  • Arterial puncture at non compressible site in previous 7 days
  • History of previous intracranial hemorrhage.
  • Intracranial neoplasm, AV malformation, or aneurysm
  • Recent head injury OR intracranial or intraspinal surgery in last 3 mo.
  • Persistent Elevated BP >185/110 mm Hg despite treatment.
  • Active ongoing internal bleeding.
  • Platelet count <100 000/mm3.
  • Current use of NOACs OR warfarin with INR >1.7 OR Inj.Enoxaparin/Heparin in therapeutic dose
  • Blood glucose concentration <2.7mmol/L (<50mg/dl).

Relative contraindications: (may consider IV alteplase on individual evaluation).

  • Seizure at onset with post ictal residual neurological deficit.
  • Signs of mild stroke in isolation or rapidly improving symptoms.
  • Pregnancy.
  • Recent GI or UT hemorrhage within the last 21 days.
  • Recent MI within previous 3 months (to exclude anterolateral infarct / STEMI)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thrombolysis arm
This arm includes patients with Acute ischemic stroke treated with thrombolysis using TeleStroke consultation
Drug: alteplase or tenecteplase
Thrombolysis using TeleStroke consultation with Neurologist
Other Names:
  • rt-PA, TNK
No Intervention: Control Arm
This arm includes age, gender matched patients with Acute Ischemic stroke who are not treated by thrombolysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90 day outcome
Time Frame: 90 days
Clinical outcome on modified Rankin Score at 90 days. This scale rates outcome from 0 to 6, with 0=no symptoms, 5=bed bound requiring assistance, 6=dead.
90 days
Discharge Outcome
Time Frame: At discharge (assessed up to 5 days)
Clinical outcome on modified Rankin Score at discharge from hospital (assessed up to 5 days). This scale rates outcome from 0 to 6, with 0=no symptoms, 5=bed bound requiring assistance, 6=dead.
At discharge (assessed up to 5 days)
Rate of Thrombolysis
Time Frame: At admission and initial management- 2 hours
Rate of utilization of IV alteplase / tenecteplase thrombolysis for acute ischemic stroke at peripheral hospitals
At admission and initial management- 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial Hemorrhage Rate
Time Frame: 24 hours
Rate of symptomatic intracranial hemorrhage at 24 hours of IV thrombolysis
24 hours
Door to Needle time
Time Frame: 1 hour
Time from Triage arrival of patient to time IV thrombolysis is initiated
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oman Ministry of Health

Collaborators

Sultan Qaboos University

Investigators

  • Principal Investigator: Arunodaya R Gujjar, MD, DM, FRCP, College of Medicine and Health Sciences, Sultan Qaboos University, Muscat, Oman
  • Study Director: Sanjay Jaju, MD, College of Medicine and Health Sciences, Sultan Qaboos University, Muscat, Oman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

July 16, 2025

First Submitted That Met QC Criteria

July 19, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC/SR-MED/MEDI/23/02
  • SQU-EC/619/2021 MREC#2641 (Other Identifier: Sultan Qaboos University, Oman)
  • MoH/CSR/21/25078 (Other Identifier: Ministry of Health, Oman)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After completion of study, anonymized IPD data can be shared on request by eligible researchers.

IPD Sharing Time Frame

Dec 2026 to Dec 2027

IPD Sharing Access Criteria

After completion of study, anonymized IPD data can be shared on request by eligible researchers.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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