Penumbra and Recanalisation Acute Computed Tomography in Ischaemic Stroke Evaluation (PRACTISE)

Stroke affects over 125,000 people each year in the UK and leaves at least 50% disabled. Treatment of stroke caused by a blockage in a blood vessel (ischaemic stroke), with clotbusting drugs improves the chances of good recovery, but must be given within 4.5 hours of onset. Currently only a small proportion of patients who arrive in hospital within 4.5 hours are treated. This is largely due to uncertainty about diagnosis and concerns about risk of bleeding associated with clotbusting medication. Patients with mild or improving symptoms in particular are often not treated because of uncertainty about relative risks and benefits. However, around one third of these patients go on to be significantly disabled. Routine CT scanning often does not show abnormalities in acute stroke (which take hours to become easily visible), and cannot show the extent or severity of blood flow changes in ischemic stroke.

We wish to investigate the value of additional CT scanning that gives information on the blood vessels (angiography, CTA) and blood flow to the brain (perfusion, CTP) by undertaking a randomised trial. Extra scans are done in the same scanner and involve some extra radiation, injections of a contrast dye, and some extra time to acquire process and interpret. The extra scans may allow better treatment decisions for patients by increasing diagnostic certainty and by better assessment of stroke severity. However, we do not know whether the potential gains from better selection justify the resources and potential treatment delays that are involved. We will investigate whether the proportion of patients given clotbusting drugs differs between the two scanning protocols; and whether the outcomes differ, using standard measures of disability. We will also investigate whether use of different scanner manufacturers' software affect interpretation of scans.

Study Overview

• Status: Unknown
• Conditions: Ischaemic Stroke
• Intervention / Treatment: Other: control imaging; Other: additional multimodal imaging

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Southern General Hospital, NHS Greater Glasgow and Clyde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of stroke eligible for IV rtPA according to current guidelines
• Informed consent
• Male or nonpregnant female ≥18 years of age
• Within 4.5 hours of onset as defined by time since last known well

Exclusion Criteria:

• Contraindications to thrombolytic drug treatment for stroke
• Pregnancy
• Known impaired renal function precluding contrast CT
• Known allergy to CT contrast agents
• Severe concurrent medical condition that would prevent participation in study procedures (e.g. cardiac failure with severe pulmonary oedema) or with life expectancy ≤ 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control imaging (NCCT); Standard imaging	Other: control imaging
Experimental: additional multimodal imaging; CT + CTA + CTP	Other: additional multimodal imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients receiving Intravenous Recombinant Tissue Plasminogen Activator (IV rtPA)	Data will be collected at 4.5 hours from onset, comparison of proportion of patients receiving treatment will only be assessed at the end of the study	4.5 hours from onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment decision and administration		4.5 hours from onset
3 month modified Rankin Scale (mRS), by intention to treat, using a Cochran Mantel Haeszel distribution analysis		90 days from onset
Safety - symptomatic Intracerebral hemorrhage (ICH) and major infarct swelling rates		7 days from onset
Diagnostic sensitivity and specificity	Data will be collected at 4.5 hours from onset, comparison of proportion of patients receiving treatment will only be assessed at the end of the study	4.5 hours from onset
3 month mRS distribution in patients i) selected for IV rtPA and excluded from IV rtPA		90 days from onset
Comparisons of efficacy & safety outcomes in Target Population (imaged as per randomised allocation and per protocol)	Data will for safety will be collected at day 7, data for efficacy will be collected at day 90. Comparison between to groups will be done at the end of the study	90 days after onset
Interobserver Agreement for rtPA eligibility between local and centrally processed CTP/CTA	Scans will be collected, centrally processed and presented again to the local clinicians in electronic form. Participants will be asked about clinical decision in view of centrally processed scans. The final data about inter observer agreement will be available at the end of the study	Six months after recruitment
Interobserver agreement in interpretation of locally processed Computed Tomography Perfusion (CTP) scans	Scans will be collected, centrally processed and presented again to the clinicians in electronic form. The final data about inter observer agreement will be available at the end of the study	Six months after recruitment

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: King's College London; University of Edinburgh; University of Glasgow
• Investigators: Principal Investigator: Keith Muir, MBChB, MSc, MD, FRCP, University of Glasgow

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): August 26, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: GN11NE418