Ischemic StrokeNCT02309970
Perfusion Computer Tomography: Imaging and Clinical Validation Following Reperfusion Therapy in Acute Ischaemic Stroke
An observational study of Ischemic Stroke, run by Rabin Medical Center at 1 site in Israel.
Trial summary
CT perfusion (CTP) of the brain is an innovative technique to identify rapidly regions which are only partially or insufficiently perfused during an acute ischemic event. The differentiation between the core infarct and the still viable penumbra is its major clinical application. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran, alteplase and endovascular
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: men and women admittedto the emergency room at Rabin Medical Center, Beilinson Campus and hospitalized at the neurology department.
Who may be able to join
- NIHSS>=8
- up to 6 hours from event onset
Who cannot join
- mRS>= 3 before the start of the event
- life expectency <1 year because other disability disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center
Petach Tiqva, Central District, 49100
Guy Raphaeli, MD, 972-50-4065626, guyre@clalit.org.il
About this study
CT perfusion (CTP) of the brain is an innovative technique to identify rapidly regions which are only partially or insufficiently perfused during an acute ischemic event. The differentiation between the core infarct and the still viable penumbra is its major clinical application. CTP helps directly in the decision-making process in the event of acute ischemic stroke by increasing the potential of success in patient who can benefit from thrombolytic/endovascular treatment.
The use of CTP in patient selection for thrombolytic/endovascular treatment was never evaluated in a prospective randomized study. Yet, clinical experience well demonstrated a good correlation between the size of the penumbra and the clinical outcome when done in early as well as late stages of the event.
Read more
The importance of identifying the penumbra in the acute phase of the ischemic stroke is widely accepted. But crucial evidence to support the predictive value of CTP to predict the clinical and anatomical/structural outcomes in the late phases (90 days after) is lacking.
Currently, the use of CTP is based on theoretical assumptions and expert opinions but a randomized prospective study to validate its use is lacking.
The current guidelines restrict the use of CTP trials and to patients that can't performed MRI scan.
- Conditions
- Ischemic Stroke
- Being tested
- acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran, alteplase, endovascular
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, DabigatranDrug
Also called Aspirin, Plavix, Coumadin, Eliquis,Xarelto, Pradaxa, Sintrom
subject in this group will receive oral treatment with anti platelet drug
alteplaseDrug
subject in this group will receive intravenous tPA
endovascularProcedure or surgery
Also called subject in this group will undergo mechanical thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Conservative | patient will get treatment with Antiplatelets or Anticoagulant depending on their clinical status/etiology Receives: Drug: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran | |
| IV tPA | patient will receive intravenous thrombolysis treatment Receives: Drug: alteplase | |
| Endovascular treatment | patient who will receive endovascular treatment Receives: Procedure: endovascular |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Raphaeli, Rabin Medical Center
- Investigators
- Guy Raphaeli, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309970
- Sponsor's protocol ID
- GR 05 - 14
- Status last verified
- Dec 2014
- First submitted
- 3 Dec 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bivard A, Spratt N, Levi C, Parsons M. Perfusion computer tomography: imaging and clinical validation in acute ischaemic stroke. Brain. 2011 Nov;134(Pt 11):3408-16. doi: 10.1093/brain/awr257.
PubMed 22075524Koton S, Bornstein NM, Green MS. Population group differences in trends in stroke mortality in Israel. Stroke. 2001 Sep;32(9):1984-8. doi: 10.1161/hs0901.095407.
PubMed 11546885National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.
PubMed 7477192Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
PubMed 18815396Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999 Dec 1;282(21):2003-11. doi: 10.1001/jama.282.21.2003.
PubMed 10591382Wardlaw JM, Zoppo G, Yamaguchi T, Berge E. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2003;(3):CD000213. doi: 10.1002/14651858.CD000213.
PubMed 12917889Parsons M, Spratt N, Bivard A, Campbell B, Chung K, Miteff F, O'Brien B, Bladin C, McElduff P, Allen C, Bateman G, Donnan G, Davis S, Levi C. A randomized trial of tenecteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2012 Mar 22;366(12):1099-107. doi: 10.1056/NEJMoa1109842.
PubMed 22435369Parsons MW. Perfusion CT: is it clinically useful? Int J Stroke. 2008 Feb;3(1):41-50. doi: 10.1111/j.1747-4949.2008.00175.x.
PubMed 18705914Goyal M, Menon BK, Derdeyn CP. Perfusion imaging in acute ischemic stroke: let us improve the science before changing clinical practice. Radiology. 2013 Jan;266(1):16-21. doi: 10.1148/radiol.12112134. No abstract available.
PubMed 23264523Gonzalez RG, Copen WA, Schaefer PW, Lev MH, Pomerantz SR, Rapalino O, Chen JW, Hunter GJ, Romero JM, Buchbinder BR, Larvie M, Hirsch JA, Gupta R. The Massachusetts General Hospital acute stroke imaging algorithm: an experience and evidence based approach. J Neurointerv Surg. 2013 May;5 Suppl 1(Suppl 1):i7-12. doi: 10.1136/neurintsurg-2013-010715. Epub 2013 Mar 14.
PubMed 23493340Abstracts of the 17th European Stroke Conference. Nice, France. May 13-16, 2008. Cerebrovasc Dis. 2008;25 Suppl 2:1-204. doi: 10.1159/000132086. No abstract available.
PubMed 22015331
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Computer Tomography: Imaging and Clinical Validation Following Reperfusion Therapy in Acute Ischaemic Stroke
- ClinicalTrials.gov ID
- NCT02309970
- Acronym / sponsor ID
- GR 05 - 14
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CT perfusion (CTP) of the brain is an innovative technique to identify rapidly regions which are only partially or insufficiently perfused during an acute ischemic event. The differentiation between the core infarct and the still viable penumbra is its major clinical application. CTP helps directly in the decision-making process in the event of acute ischemic stroke by increasing the potential of success in patient who can benefit from thrombolytic/endovascular treatment.
The use of CTP in patient selection for thrombolytic/endovascular treatment was never evaluated in a prospective randomized study. Yet, clinical experience well demonstrated a good correlation between the size of the penumbra and the clinical outcome when done in early as well as late stages of the event.
The importance of identifying the penumbra in the acute phase of the ischemic stroke is widely accepted. But crucial evidence to support the predictive value of CTP to predict the clinical and anatomical/structural outcomes in the late phases (90 days after) is lacking.
Currently, the use of CTP is based on theoretical assumptions and expert opinions but a randomized prospective study to validate its use is lacking.
The current guidelines restrict the use of CTP trials and to patients that can't performed MRI scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative | – | Drug: acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatranpatient will get treatment with Antiplatelets or Anticoagulant depending on their clinical status/etiology |
| IV tPA | – | Drug: alteplasepatient will receive intravenous thrombolysis treatment |
| Endovascular treatment | – | Procedure: endovascularpatient who will receive endovascular treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men and women admittedto the emergency room at Rabin Medical Center, Beilinson Campus and hospitalized at the neurology department.
Key inclusion criteria (2 listed)
- NIHSS>=8
- up to 6 hours from event onset
Key exclusion criteria (2 listed)
- mRS>= 3 before the start of the event
- life expectency <1 year because other disability disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, DabigatranAlso: Aspirin, Plavix, Coumadin, Eliquis,Xarelto, Pradaxa, Sintromsubject in this group will receive oral treatment with anti platelet drug | Drug | Conservative |
| alteplasesubject in this group will receive intravenous tPA | Drug | IV tPA |
| endovascularAlso: subject in this group will undergo mechanical thrombectomy | Procedure or surgery | Endovascular treatment |
Primary outcome
The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke
Time frame: three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Background: PubMed 22075524Bivard A, Spratt N, Levi C, Parsons M. Perfusion computer tomography: imaging and clinical validation in acute ischaemic stroke. Brain. 2011 Nov;134(Pt 11):3408-16. doi: 10.1093/brain/awr257.
- Results publication: PubMed 11546885Koton S, Bornstein NM, Green MS. Population group differences in trends in stroke mortality in Israel. Stroke. 2001 Sep;32(9):1984-8. doi: 10.1161/hs0901.095407.
- Results publication: PubMed 7477192National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.
- Results publication: PubMed 18815396Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.
- Results publication: PubMed 10591382Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999 Dec 1;282(21):2003-11. doi: 10.1001/jama.282.21.2003.
- Results publication: PubMed 12917889Wardlaw JM, Zoppo G, Yamaguchi T, Berge E. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2003;(3):CD000213. doi: 10.1002/14651858.CD000213.
- Results publication: PubMed 22435369Parsons M, Spratt N, Bivard A, Campbell B, Chung K, Miteff F, O'Brien B, Bladin C, McElduff P, Allen C, Bateman G, Donnan G, Davis S, Levi C. A randomized trial of tenecteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2012 Mar 22;366(12):1099-107. doi: 10.1056/NEJMoa1109842.
- Results publication: PubMed 18705914Parsons MW. Perfusion CT: is it clinically useful? Int J Stroke. 2008 Feb;3(1):41-50. doi: 10.1111/j.1747-4949.2008.00175.x.
- Results publication: PubMed 23264523Goyal M, Menon BK, Derdeyn CP. Perfusion imaging in acute ischemic stroke: let us improve the science before changing clinical practice. Radiology. 2013 Jan;266(1):16-21. doi: 10.1148/radiol.12112134. No abstract available.
- Results publication: PubMed 23493340Gonzalez RG, Copen WA, Schaefer PW, Lev MH, Pomerantz SR, Rapalino O, Chen JW, Hunter GJ, Romero JM, Buchbinder BR, Larvie M, Hirsch JA, Gupta R. The Massachusetts General Hospital acute stroke imaging algorithm: an experience and evidence based approach. J Neurointerv Surg. 2013 May;5 Suppl 1(Suppl 1):i7-12. doi: 10.1136/neurintsurg-2013-010715. Epub 2013 Mar 14.
- Results publication: PubMed 22015331Abstracts of the 17th European Stroke Conference. Nice, France. May 13-16, 2008. Cerebrovasc Dis. 2008;25 Suppl 2:1-204. doi: 10.1159/000132086. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Raphaeli, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Raphaeli, MD (972-50-4065626, guyre@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive value of CTP in identifying penumbra (salvagable brain tissue) in event of ischemic stroke (time frame: three month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02309970, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.