Clinical trial NCT02360670: Penumbra and Recanalisation Acute Computed Tomography in Ischaemic Stroke Evaluation
Official title: Penumbra and Recanalisation Acute Computed Tomography in Ischaemic Stroke Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischaemic Stroke
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: University of Edinburgh
name: King's College London
First posted: 2015-02-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients receiving Intravenous Recombinant Tissue Plasminogen Activator (IV rtPA)
timeFrame: 4.5 hours from onset
Secondary outcomes:
measure: Time to treatment decision and administration
timeFrame: 4.5 hours from onset
measure: 3 month modified Rankin Scale (mRS), by intention to treat, using a Cochran Mantel Haeszel distribution analysis
timeFrame: 90 days from onset
measure: Safety - symptomatic Intracerebral hemorrhage (ICH) and major infarct swelling rates
timeFrame: 7 days from onset
measure: Diagnostic sensitivity and specificity
timeFrame: 4.5 hours from onset
measure: 3 month mRS distribution in patients i) selected for IV rtPA and excluded from IV rtPA
timeFrame: 90 days from onset
measure: Comparisons of efficacy & safety outcomes in Target Population (imaged as per randomised allocation and per protocol)
timeFrame: 90 days after onset
measure: Interobserver Agreement for rtPA eligibility between local and centrally processed CTP/CTA
timeFrame: Six months after recruitment
measure: Interobserver agreement in interpretation of locally processed Computed Tomography Perfusion (CTP) scans
timeFrame: Six months after recruitment
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Southern General Hospital, NHS Greater Glasgow and Clyde
Study officials:
affiliation: University of Glasgow
name: Keith Muir, MBChB, MSc, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: