TeleStroke-Guided Thrombolysis for Acute Ischemic Stroke in Oman

NCT07721129 | Not Yet Recruiting Phase 4

• 3 other identifiers: RC/SR-MED/MEDI/23/02SQU-EC/619/2021 MREC#2641MoH/CSR/21/25078
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ischemic Stroke, Acute; Ischemic Stroke

Keywords

Stroke; Acute Ischemic Stroke; Thrombolysis; Telestroke; Telemedicine

Outcome Measures

Primary Outcomes (3)

• 90 day outcome

  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

  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

  Rate of utilization of IV alteplase / tenecteplase thrombolysis for acute ischemic stroke at peripheral hospitals

  At admission and initial management- 2 hours

Secondary Outcomes (2)

• Intracranial Hemorrhage Rate

  24 hours

• Door to Needle time

  1 hour

Study Arms (2)

Thrombolysis arm

EXPERIMENTAL

This arm includes patients with Acute ischemic stroke treated with thrombolysis using TeleStroke consultation

Drug: alteplase or tenecteplase

Control Arm

NO INTERVENTION

This arm includes age, gender matched patients with Acute Ischemic stroke who are not treated by thrombolysis.

Interventions

alteplase or tenecteplase DRUG

Thrombolysis using TeleStroke consultation with Neurologist

Also known as: rt-PA, TNK

Thrombolysis arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oman Ministry of Health: lead
• Sultan Qaboos University: collaborator

Related Publications (5)

• Ganguly SS, Gujjar AR, Al Harthi H, Al Hashmi A, Jaju S, Al-Mahrezi A, Al-Asmi AR. Risk Factors for Ischaemic Stroke in an Omani Community: A case-control study. Sultan Qaboos Univ Med J. 2021 Nov;21(4):585-590. doi: 10.18295/squmj.4.2021.043. Epub 2021 Nov 25.

  PMID: 34888078 BACKGROUND

• Gujjar AR, Lal D, Kumar S, Ganguly SS, Raniga S, Al-Azri F, Al-Asmi AR. Coexisting Dual Mechanisms of Ischaemic Stroke: Frequency and outcomes in a university hospital-based stroke registry. Sultan Qaboos Univ Med J. 2025 May 2;25(1):200-208. doi: 10.18295/2075-0528.2833.

  PMID: 40641688 BACKGROUND

• Commiskey P, Afshinnik A, Cothren E, Gropen T, Iwuchukwu I, Jennings B, McGrade HC, Mora-Guillot J, Sabharwal V, Vidal GA, Zweifler RM, Gaines K. Description of a novel telemedicine-enabled comprehensive system of care: drip and ship plus drip and keep within a system of stroke care delivery. J Telemed Telecare. 2017 Apr;23(3):428-436. doi: 10.1177/1357633X16637967. Epub 2016 Mar 16.

  PMID: 26989161 BACKGROUND

• Demaerschalk BM, Berg J, Chong BW, Gross H, Nystrom K, Adeoye O, Schwamm L, Wechsler L, Whitchurch S. American Telemedicine Association: Telestroke Guidelines. Telemed J E Health. 2017 May;23(5):376-389. doi: 10.1089/tmj.2017.0006. Epub 2017 Apr 6.

  PMID: 28384077 BACKGROUND

• Boulanger JM, Lindsay MP, Gubitz G, Smith EE, Stotts G, Foley N, Bhogal S, Boyle K, Braun L, Goddard T, Heran M, Kanya-Forster N, Lang E, Lavoie P, McClelland M, O'Kelly C, Pageau P, Pettersen J, Purvis H, Shamy M, Tampieri D, vanAdel B, Verbeek R, Blacquiere D, Casaubon L, Ferguson D, Hegedus Y, Jacquin GJ, Kelly M, Kamal N, Linkewich B, Lum C, Mann B, Milot G, Newcommon N, Poirier P, Simpkin W, Snieder E, Trivedi A, Whelan R, Eustace M, Smitko E, Butcher K. Canadian Stroke Best Practice Recommendations for Acute Stroke Management: Prehospital, Emergency Department, and Acute Inpatient Stroke Care, 6th Edition, Update 2018. Int J Stroke. 2018 Dec;13(9):949-984. doi: 10.1177/1747493018786616. Epub 2018 Jul 18.

  PMID: 30021503 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Tissue Plasminogen Activator; Tenecteplase

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Arunodaya R Gujjar, MD, DM, FRCP

  College of Medicine and Health Sciences, Sultan Qaboos University, Muscat, Oman

  PRINCIPAL INVESTIGATOR

• Sanjay Jaju, MD

  College of Medicine and Health Sciences, Sultan Qaboos University, Muscat, Oman

  STUDY DIRECTOR

Central Study Contacts

Arunodaya R Gujjar, MD, FRCP

CONTACT

+968 95154022; arunoday@squ.edu.om

Ali Al-Belushi, MD

CONTACT

+96896069012; altaweel1@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor at 90 days would be masked and unaware of initial intervention arm in which the patient was.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective case series

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Dec 2026 to Dec 2027
• Access Criteria: After completion of study, anonymized IPD data can be shared on request by eligible researchers.