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

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ClinicalTrials.gov Identifier: NCT02360670
Recruitment Status : Unknown
Verified August 2018 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Active, not recruiting
First Posted : February 10, 2015
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
University of Glasgow
University of Edinburgh
King's College London
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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.


Condition or disease Intervention/treatment Phase
Ischaemic Stroke Other: control imaging Other: additional multimodal imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Penumbra and Recanalisation Acute Computed Tomography in Ischaemic Stroke Evaluation
Study Start Date : February 2015
Estimated Primary Completion Date : August 26, 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

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



Primary Outcome Measures :
  1. Proportion of patients receiving Intravenous Recombinant Tissue Plasminogen Activator (IV rtPA) [ Time Frame: 4.5 hours from onset ]
    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


Secondary Outcome Measures :
  1. Time to treatment decision and administration [ Time Frame: 4.5 hours from onset ]
  2. 3 month modified Rankin Scale (mRS), by intention to treat, using a Cochran Mantel Haeszel distribution analysis [ Time Frame: 90 days from onset ]
  3. Safety - symptomatic Intracerebral hemorrhage (ICH) and major infarct swelling rates [ Time Frame: 7 days from onset ]
  4. Diagnostic sensitivity and specificity [ Time Frame: 4.5 hours from onset ]
    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

  5. 3 month mRS distribution in patients i) selected for IV rtPA and excluded from IV rtPA [ Time Frame: 90 days from onset ]
  6. Comparisons of efficacy & safety outcomes in Target Population (imaged as per randomised allocation and per protocol) [ Time Frame: 90 days after onset ]
    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

  7. Interobserver Agreement for rtPA eligibility between local and centrally processed CTP/CTA [ Time Frame: Six months after recruitment ]
    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

  8. Interobserver agreement in interpretation of locally processed Computed Tomography Perfusion (CTP) scans [ Time Frame: Six months after recruitment ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360670


Locations
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United Kingdom
Southern General Hospital, NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
University of Edinburgh
King's College London
Investigators
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Principal Investigator: Keith Muir, MBChB, MSc, MD, FRCP University of Glasgow
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02360670    
Other Study ID Numbers: GN11NE418
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia