Stroke, AcuteiCASNCT02225730
Imaging Collaterals in Acute Stroke (iCAS)
An observational study of Stroke, Acute, run by Stanford University at 4 sites in United States.
Trial summary
Stroke is caused by a sudden blockage of a blood vessel that delivers blood to the brain. Unblocking the blood vessel with a blood clot removal device restores blood flow and if done quickly may prevent the disability that can be caused by a stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- How many people
- 187 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2013to 31 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the hospital with diagnosis of acute ischemic stroke who are scheduled to undergo (or have undergone) acute IA stroke therapy will be screened for study enrollment.
Who may be able to join
- Age 18 and older
- Clinical diagnosis of ischemic stroke and an associated score on the NIHSS of 5 or more points
- Planned to undergo (or has undergone) intra-arterial (IA) thrombectomy and/or thrombolysis for acute hemispheric stroke. (Either as primary therapy or as adjuvant therapy following intravenous tPA treatment)
- Planned to undergo or has undergone an MR brain scan including MR perfusion imaging (ASL \& bolus PWI) and MR angiography of the circle of Willis prior to IA therapy
- Intra-arterial thrombectomy can be started within 90 minutes of completion of the MR perfusion scan and within 24 hours of symptom onset (Start of IA therapy is defined as the time of insertion of the femoral artery sheath; Time of brain scan is defined as the time that the scan is completed)
- Able to obtain informed consent
Who cannot join
- Any pre-existing illness resulting in a modified Rankin Scale Score of 2 or higher prior to the qualifying stroke
- Creatinine clearance < 40 ml/min based on the NIDDK four-variable MDRD method (non-weight based)
- Documented allergy to MR contrast agent
- MRI contraindications (pacemaker, etc.)
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Eden Medical Center
Castro Valley, California, 94546
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Swedish Hospital
Seattle, Washington, 98122
Stanford University Medical Center
Stanford, California, 94035
About this study
Official title: Imaging Collaterals in Acute Stroke
Stroke is caused by a sudden blockage of a blood vessel that delivers blood to the brain. Unblocking the blood vessel with a blood clot removal device restores blood flow and if done quickly may prevent the disability that can be caused by a stroke.
However, not all stroke patients benefit from having their blood vessel unblocked.
The aim of this study is to determine if special brain imaging, called MRI, can be used to identify which stroke patients are most likely to benefit from attempts to unblock their blood vessel with a special blood clot removal device. In particular, we will assess in this trial whether a noncontrast MR imaging sequence, arterial spin labeling (ASL), can demonstrate the presence of collateral blood flow (compared with a gold standard of the angiogram) and whether it is useful to predict who will benefit from treatment.
Read the detailed description
Intravenous tissue plasminogen activator (IV tPA) is the standard of care treatment for stroke patients when treatment can be initiated within 3 hours after symptom onset. Unfortunately, only a very small fraction of stroke patients is treated with tPA, and benefits from tPA. This is the result of two main limitations of tPA therapy.
First, the proportion of patients that can be treated with iv tPA is small. Because of the narrow three hour time-window during which tPA is effective, only patients who arrive to the hospital early on can be treated with tPA. Most stroke patients, however, arrive at the hospital after the three-hour time-window and are therefore excluded from tPA treatment. Second, stroke patients who receive tPA do not always benefit because the treatment does not restore blood flow in all patients.
Patients with persistent blood vessel occlusions and no improvement in their clinical condition after receiving tPA or those arriving at the hospital outside the 3 hour time window routinely undergo mechanical clot removal to open an occluded blood vessel in the brain.
Mechanical clot removal increases the percentage of stroke patients who achieve recanalization, and as a result may increase the proportion of patients who have good clinical outcomes. However it is unclear for which stroke patients mechanical thrombectomy is most suitable. Although effective at removing blood-clots, it appears that mechanical clot retrieval is not beneficial for all patients. Whereas some patients benefit, others experience no effect, and yet others are likely harmed by mechanical clot retrieval. In order to avoid harm and maximize benefit it is important to know, prior to initiation of the mechanical clot retrieval procedure, if the procedure is likely to result in a clinical improvement. We hypothesize that the response to mechanical clot retrieval can be predicted based on characteristics of an MRI scan obtained just prior to the retrieval procedure. In particular, this study will assess whether a new non-contrast MR imaging method, arterial spin labeling (ASL), which measures cerebral blood flow and can give insight into collateral flow, is effective at predicting who will benefit most from treatment. The investigators hope to learn if these new MRI techniques can help identify which patients are most likely to benefit from mechanical clot removal after receiving tPA.
- Conditions
- Stroke, Acute
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
favorable clinical response
A "favorable clinical response", defined as an 8-point or more improvement on the NIH score when comparing the baseline score to the 30-day score or NIH score of 0 or a 30-day NIH score of 0-1
Measured: day 30
Secondary outcomes (1)
modified Rankin Score
90 day modified Rankin Score 5-6 and 90 day modified Rankin distribution
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startSep 2013
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Medical Center, University of Pittsburgh
- Responsible party
- Principal investigator, Greg Zaharchuk, Stanford University
- Investigators
- Gregory Zaharchuk, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225730
- Sponsor's protocol ID
- 28213
- Acronym
- iCAS
- Status last verified
- Mar 2020
- First submitted
- 22 Aug 2014
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu Y, Christensen S, Ouyang J, Scalzo F, Liebeskind DS, Lansberg MG, Albers GW, Zaharchuk G. Predicting Hypoperfusion Lesion and Target Mismatch in Stroke from Diffusion-weighted MRI Using Deep Learning. Radiology. 2023 Apr;307(1):e220882. doi: 10.1148/radiol.220882. Epub 2022 Dec 6.
PubMed 36472536Thamm T, Guo J, Rosenberg J, Liang T, Marks MP, Christensen S, Do HM, Kemp SM, Adair E, Eyngorn I, Mlynash M, Jovin TG, Keogh BP, Chen HJ, Lansberg MG, Albers GW, Zaharchuk G. Contralateral Hemispheric Cerebral Blood Flow Measured With Arterial Spin Labeling Can Predict Outcome in Acute Stroke. Stroke. 2019 Dec;50(12):3408-3415. doi: 10.1161/STROKEAHA.119.026499. Epub 2019 Oct 17.
PubMed 31619150
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Collaterals in Acute Stroke
- ClinicalTrials.gov ID
- NCT02225730
- Acronym / sponsor ID
- iCAS / 28213
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Swedish Medical Center, University of Pittsburgh
- Study start
- Sep 2013
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 26 Aug 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.
Stroke is caused by a sudden blockage of a blood vessel that delivers blood to the brain. Unblocking the blood vessel with a blood clot removal device restores blood flow and if done quickly may prevent the disability that can be caused by a stroke.
However, not all stroke patients benefit from having their blood vessel unblocked.
The aim of this study is to determine if special brain imaging, called MRI, can be used to identify which stroke patients are most likely to benefit from attempts to unblock their blood vessel with a special blood clot removal device. In particular, we will assess in this trial whether a noncontrast MR imaging sequence, arterial spin labeling (ASL), can demonstrate the presence of collateral blood flow (compared with a gold standard of the angiogram) and whether it is useful to predict who will benefit from treatment.
Detailed description
Intravenous tissue plasminogen activator (IV tPA) is the standard of care treatment for stroke patients when treatment can be initiated within 3 hours after symptom onset. Unfortunately, only a very small fraction of stroke patients is treated with tPA, and benefits from tPA. This is the result of two main limitations of tPA therapy.
First, the proportion of patients that can be treated with iv tPA is small. Because of the narrow three hour time-window during which tPA is effective, only patients who arrive to the hospital early on can be treated with tPA. Most stroke patients, however, arrive at the hospital after the three-hour time-window and are therefore excluded from tPA treatment. Second, stroke patients who receive tPA do not always benefit because the treatment does not restore blood flow in all patients.
Patients with persistent blood vessel occlusions and no improvement in their clinical condition after receiving tPA or those arriving at the hospital outside the 3 hour time window routinely undergo mechanical clot removal to open an occluded blood vessel in the brain.
Mechanical clot removal increases the percentage of stroke patients who achieve recanalization, and as a result may increase the proportion of patients who have good clinical outcomes. However it is unclear for which stroke patients mechanical thrombectomy is most suitable. Although effective at removing blood-clots, it appears that mechanical clot retrieval is not beneficial for all patients. Whereas some patients benefit, others experience no effect, and yet others are likely harmed by mechanical clot retrieval. In order to avoid harm and maximize benefit it is important to know, prior to initiation of the mechanical clot retrieval procedure, if the procedure is likely to result in a clinical improvement. We hypothesize that the response to mechanical clot retrieval can be predicted based on characteristics of an MRI scan obtained just prior to the retrieval procedure. In particular, this study will assess whether a new non-contrast MR imaging method, arterial spin labeling (ASL), which measures cerebral blood flow and can give insight into collateral flow, is effective at predicting who will benefit most from treatment. The investigators hope to learn if these new MRI techniques can help identify which patients are most likely to benefit from mechanical clot removal after receiving tPA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the hospital with diagnosis of acute ischemic stroke who are scheduled to undergo (or have undergone) acute IA stroke therapy will be screened for study enrollment.
Key inclusion criteria (6 listed)
- Age 18 and older
- Clinical diagnosis of ischemic stroke and an associated score on the NIHSS of 5 or more points
- Planned to undergo (or has undergone) intra-arterial (IA) thrombectomy and/or thrombolysis for acute hemispheric stroke. (Either as primary therapy or as adjuvant therapy following intravenous tPA treatment)
- Planned to undergo or has undergone an MR brain scan including MR perfusion imaging (ASL \& bolus PWI) and MR angiography of the circle of Willis prior to IA therapy
- Intra-arterial thrombectomy can be started within 90 minutes of completion of the MR perfusion scan and within 24 hours of symptom onset (Start of IA therapy is defined as the time of insertion of the femoral artery sheath; Time of brain scan is defined as the time that the scan is completed)
Key exclusion criteria (5 listed)
- Any pre-existing illness resulting in a modified Rankin Scale Score of 2 or higher prior to the qualifying stroke
- Creatinine clearance < 40 ml/min based on the NIDDK four-variable MDRD method (non-weight based)
- Documented allergy to MR contrast agent
- MRI contraindications (pacemaker, etc.)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
favorable clinical response
Time frame: day 30
A "favorable clinical response", defined as an 8-point or more improvement on the NIH score when comparing the baseline score to the 30-day score or NIH score of 0 or a 30-day NIH score of 0-1
1 secondary outcome
modified Rankin Score
Time frame: day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Derived from this study: PubMed 36472536Yu Y, Christensen S, Ouyang J, Scalzo F, Liebeskind DS, Lansberg MG, Albers GW, Zaharchuk G. Predicting Hypoperfusion Lesion and Target Mismatch in Stroke from Diffusion-weighted MRI Using Deep Learning. Radiology. 2023 Apr;307(1):e220882. doi: 10.1148/radiol.220882. Epub 2022 Dec 6.
- Derived from this study: PubMed 31619150Thamm T, Guo J, Rosenberg J, Liang T, Marks MP, Christensen S, Do HM, Kemp SM, Adair E, Eyngorn I, Mlynash M, Jovin TG, Keogh BP, Chen HJ, Lansberg MG, Albers GW, Zaharchuk G. Contralateral Hemispheric Cerebral Blood Flow Measured With Arterial Spin Labeling Can Predict Outcome in Acute Stroke. Stroke. 2019 Dec;50(12):3408-3415. doi: 10.1161/STROKEAHA.119.026499. Epub 2019 Oct 17.
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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.
Gregory Zaharchuk, MD principal investigator
Stanford University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Stanford University at 4 sites in United States.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
favorable clinical response (time frame: day 30). 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 NCT02225730, which also lists 2 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 19 Mar 2020.