Penumbra and Recanalisation Acute Computed Tomography in Ischaemic Stroke Evaluation

NCT02360670 | Unknown DMC

• 1 other identifier: GN11NE418
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischaemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  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

Study Arms (2)

Control imaging (NCCT)

PLACEBO COMPARATOR

Standard imaging

Other: control imaging

additional multimodal imaging

EXPERIMENTAL

CT + CTA + CTP

Other: additional multimodal imaging

Interventions

control imaging OTHER

Control imaging (NCCT)

additional multimodal imaging OTHER

additional multimodal imaging

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• University of Edinburgh: collaborator
• King's College London: collaborator

Study Sites (1)

Southern General Hospital, NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Keith Muir, MBChB, MSc, MD, FRCP

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 10, 2015
• Study Start: February 1, 2015
• Primary Completion: August 26, 2018
• Study Completion: November 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

GB (1)