StrokeNCT03367286
Comparison Influence to Prognosis of CTP and MRP in AIS Patients
An observational study of Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Acute ischemia stroke (AIS) is the leading cause of death in China. Thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) has been proven to reduce disability in AIS patients within 4.5 hours after symptom onset. However, only 2% of AIS patients received thrombolytic therapy in China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- inspection mode
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2009to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: acute ischemic stroke patients
Who may be able to join
- Provision of informed consent;
- Male and female adults aged 18-80 years old;
- For patients accepting CTP or MRP over 4.5 hours after stroke onset, imaging criteria: infarct core volume <70mL, perfusion leison volume / infarct core volume >1.2, and absolute mismatch >10 mL.
Who cannot join
- Standard contraindications to rt-PA;
- Contraindication to imaging with contrast agents;
- Pre-stroke mRS score of ≥2 (indicating previous disability);
- Participation in any investigational study in the previous 30 days;
- Any terminal illness such that patient would not be expected to survive more than one-year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of Zhejiang University
Hangzhou, 310000
Min Lou, Ph.D, 13958007213, loumingxc@vip.sina.com
About this study
Official title: Comparison Influence to Prognosis of Computed Tomography Perfusion (CTP) and Magnetic Resonance Perfusion (MRP) in Acute Ischemic Stroke (AIS) Patients
Acute ischemia stroke (AIS) is the leading cause of death in China. Thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) has been proven to reduce disability in AIS patients within 4.5 hours after symptom onset. However, only 2% of AIS patients received thrombolytic therapy in China.
Perfusion imaging is demonstrated to increase the rate of thrombolytic therapy by identifying the ischemic infarct core (the brain tissue that is irreversibly injured) and the ischemia penumbra (the brain tissue surrounding the ischemia infarct core that is hypoperfused but still viable) for those patients with extending therapeutic window (beyond the current 4.5 hours after symptom onset), as well as minor stroke or those with atypical symptoms.
Read more
Three prospective clinical trials, DEFUSE, DEFUSE-2 and EPITHET, has confirmed that mismatch between perfusion weighted-imaging (PWI) and diffusion weighted-imaging (DWI) correspond to the ischemic penumbra whereas DWI provides information of the ischemia infarct core and major reperfusion relate to good clinical outcome in extending therapeutic window AIS patients with DWI-PWI mismatch.
Computed tomography perfusion (CTP) may be a potential alternative technology for recognition of reversibly damaged brain tissue in AIS patients, with the prominent advantage of fast scan. Recent studies also demonstrated that CTP could select eligible candidates for reperfusion therapy. More recently, with data of EXTEND-IA, reperfusion therapy in AIS patients with CTP mismatch (using a CT time to maximum >6 s as ischemic hypoperfusion volume and a CT relative cerebral blood flow <30% of that in normal tissue as ischemic core volume) were related to good clinical outcome.
However, plenty of studies demonstrated CT cerebral blood volume did not always predict ischemic infarct core in AIS patients. A recent study also confirmed the poor contrast: noise ratios of CT cerebral blood volume and CT cerebral blood flow result in large measurement error, compared with those of diffusion weighted imaging (DWI), making it problematic to substitute DWI in selecting individual AIS patients for reperfusion treatment.
Based on those studies, it is still remained unclear whether CTP can be an alternative choice to replace magnetic resonance perfusion (MRP) in AIS patients with extending therapeutic windows. So in this study, the investigators try to determine whether baseline CTP profiles have a comparable ability to MRP in identifying patients who have a robust clinical response after early reperfusion.
Read the detailed description
This is a prospective, non-blind, single-center clinical trial to evaluate whether baseline computed tomography perfusion (CTP) profiles have a comparable ability to magnetic resonance perfusion (MRP) in identifying acute ischemia stroke (AIS) patients who have a robust clinical response after early reperfusion.
The study will enroll 1000 patients, and patients will be divided into 2 groups according to the imaging available situation (to see which can provide immediately): CTP scan group and MRP scan group.
Core: CT: cerebral blood flow <30% of that in normal tissue / MR: ADC < 600 ×D10-6 mm2 / s.
Hypoperfusion: CT / MR: time to maximum >6.
For patients accepting CTP or MRP over 4.5 hours after stroke onset, only patients who meet imaging criteria (infarct core volume < 70mL, perfusion lesion volume / infarct core volume >1.2, and absolute mismatch >10 mL) at baseline will receive recombinant tissue plasminogen activator (rt-PA) intravenous thrombolysis. CTP or MRP will be performed at 24 hours after thrombolytic therapy. Modified Rankin score (mRS) will be measured at 3 months after stroke onset.
Study Endpoints: Primary endpoint: mRS 0-2 at 3 months. Secondary endpoints: (1) symptomatic intracranial haemorrhage, (2) reperfusion, (3) recanalization, and (4) infarct growth at 24 hours.
Criteria:
Inclusion Criteria:
- Provision of informed consent;
- Male and female adults aged 18-80 years old;
- For patients accepting CTP or MRP over 4.5 hours after stroke onset, imaging criteria: infarct core volume <70mL, perfusion leison volume / infarct core volume >1.2, and absolute mismatch >10 mL.
Exclusion Criteria:
- Standard contraindications to rt-PA;
- Contraindication to imaging with contrast agents;
- Pre-stroke mRS score of ≥2 (indicating previous disability);
- Participation in any investigational study in the previous 30 days;
- Any terminal illness such that patient would not be expected to survive more than one-year.
- Conditions
- Stroke
- Being tested
- inspection mode
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspection modeOther
different inspection modes：Computed Tomography Perfusion (CTP) or Magnetic Resonance Perfusion (MRP)
| Study group | Role | What they receive |
|---|---|---|
| Computed Tomography Perfusion (CTP) | Not described Receives: Other: inspection mode | |
| Magnetic Resonance Perfusion (MRP) | Not described Receives: Other: inspection mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale at 90 days
modified Rankin Scale at 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start30 Jun 2009
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2026 (estimated)
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 StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367286
- Sponsor's protocol ID
- CIPPIS
- Status last verified
- Nov 2022
- First submitted
- 5 Oct 2017
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou Y, He Y, Yan S, Chen L, Zhang R, Xu J, Hu H, Liebeskind DS, Lou M. Reperfusion Injury Is Associated With Poor Outcome in Patients With Recanalization After Thrombectomy. Stroke. 2023 Jan;54(1):96-104. doi: 10.1161/STROKEAHA.122.039337. Epub 2022 Nov 11.
PubMed 36367100Yan S, Zhang X, Zhang R, Xu J, Lou M. Early Fibrinogen Depletion and Symptomatic Intracranial Hemorrhage After Reperfusion Therapy. Stroke. 2019 Oct;50(10):2716-2721. doi: 10.1161/STROKEAHA.119.025711. Epub 2019 Aug 9.
PubMed 31394994
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Influence to Prognosis of Computed Tomography Perfusion (CTP) and Magnetic Resonance Perfusion (MRP) in Acute Ischemic Stroke (AIS) Patients
- ClinicalTrials.gov ID
- NCT03367286
- Acronym / sponsor ID
- CIPPIS
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Jun 2009 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Dec 2017 (actual)
- 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.
Acute ischemia stroke (AIS) is the leading cause of death in China. Thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) has been proven to reduce disability in AIS patients within 4.5 hours after symptom onset. However, only 2% of AIS patients received thrombolytic therapy in China.
Perfusion imaging is demonstrated to increase the rate of thrombolytic therapy by identifying the ischemic infarct core (the brain tissue that is irreversibly injured) and the ischemia penumbra (the brain tissue surrounding the ischemia infarct core that is hypoperfused but still viable) for those patients with extending therapeutic window (beyond the current 4.5 hours after symptom onset), as well as minor stroke or those with atypical symptoms.
Three prospective clinical trials, DEFUSE, DEFUSE-2 and EPITHET, has confirmed that mismatch between perfusion weighted-imaging (PWI) and diffusion weighted-imaging (DWI) correspond to the ischemic penumbra whereas DWI provides information of the ischemia infarct core and major reperfusion relate to good clinical outcome in extending therapeutic window AIS patients with DWI-PWI mismatch.
Computed tomography perfusion (CTP) may be a potential alternative technology for recognition of reversibly damaged brain tissue in AIS patients, with the prominent advantage of fast scan. Recent studies also demonstrated that CTP could select eligible candidates for reperfusion therapy. More recently, with data of EXTEND-IA, reperfusion therapy in AIS patients with CTP mismatch (using a CT time to maximum >6 s as ischemic hypoperfusion volume and a CT relative cerebral blood flow <30% of that in normal tissue as ischemic core volume) were related to good clinical outcome.
However, plenty of studies demonstrated CT cerebral blood volume did not always predict ischemic infarct core in AIS patients. A recent study also confirmed the poor contrast: noise ratios of CT cerebral blood volume and CT cerebral blood flow result in large measurement error, compared with those of diffusion weighted imaging (DWI), making it problematic to substitute DWI in selecting individual AIS patients for reperfusion treatment.
Based on those studies, it is still remained unclear whether CTP can be an alternative choice to replace magnetic resonance perfusion (MRP) in AIS patients with extending therapeutic windows. So in this study, the investigators try to determine whether baseline CTP profiles have a comparable ability to MRP in identifying patients who have a robust clinical response after early reperfusion.
Detailed description
This is a prospective, non-blind, single-center clinical trial to evaluate whether baseline computed tomography perfusion (CTP) profiles have a comparable ability to magnetic resonance perfusion (MRP) in identifying acute ischemia stroke (AIS) patients who have a robust clinical response after early reperfusion.
The study will enroll 1000 patients, and patients will be divided into 2 groups according to the imaging available situation (to see which can provide immediately): CTP scan group and MRP scan group.
Core: CT: cerebral blood flow <30% of that in normal tissue / MR: ADC < 600 ×D10-6 mm2 / s.
Hypoperfusion: CT / MR: time to maximum >6.
For patients accepting CTP or MRP over 4.5 hours after stroke onset, only patients who meet imaging criteria (infarct core volume < 70mL, perfusion lesion volume / infarct core volume >1.2, and absolute mismatch >10 mL) at baseline will receive recombinant tissue plasminogen activator (rt-PA) intravenous thrombolysis. CTP or MRP will be performed at 24 hours after thrombolytic therapy. Modified Rankin score (mRS) will be measured at 3 months after stroke onset.
Study Endpoints: Primary endpoint: mRS 0-2 at 3 months. Secondary endpoints: (1) symptomatic intracranial haemorrhage, (2) reperfusion, (3) recanalization, and (4) infarct growth at 24 hours.
Criteria:
Inclusion Criteria:
- Provision of informed consent;
- Male and female adults aged 18-80 years old;
- For patients accepting CTP or MRP over 4.5 hours after stroke onset, imaging criteria: infarct core volume <70mL, perfusion leison volume / infarct core volume >1.2, and absolute mismatch >10 mL.
Exclusion Criteria:
- Standard contraindications to rt-PA;
- Contraindication to imaging with contrast agents;
- Pre-stroke mRS score of ≥2 (indicating previous disability);
- Participation in any investigational study in the previous 30 days;
- Any terminal illness such that patient would not be expected to survive more than one-year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computed Tomography Perfusion (CTP) | – | Other: inspection mode |
| Magnetic Resonance Perfusion (MRP) | – | Other: inspection mode |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- acute ischemic stroke patients
Key inclusion criteria (3 listed)
- Provision of informed consent;
- Male and female adults aged 18-80 years old;
- For patients accepting CTP or MRP over 4.5 hours after stroke onset, imaging criteria: infarct core volume <70mL, perfusion leison volume / infarct core volume >1.2, and absolute mismatch >10 mL.
Key exclusion criteria (5 listed)
- Standard contraindications to rt-PA;
- Contraindication to imaging with contrast agents;
- Pre-stroke mRS score of ≥2 (indicating previous disability);
- Participation in any investigational study in the previous 30 days;
- Any terminal illness such that patient would not be expected to survive more than one-year.
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 |
|---|---|---|
| inspection modedifferent inspection modes：Computed Tomography Perfusion (CTP) or Magnetic Resonance Perfusion (MRP) | Other | Computed Tomography Perfusion (CTP), Magnetic Resonance Perfusion (MRP) |
Primary outcome
modified Rankin Scale at 90 days
Time frame: 90 days
modified Rankin Scale at 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Derived from this study: PubMed 36367100Zhou Y, He Y, Yan S, Chen L, Zhang R, Xu J, Hu H, Liebeskind DS, Lou M. Reperfusion Injury Is Associated With Poor Outcome in Patients With Recanalization After Thrombectomy. Stroke. 2023 Jan;54(1):96-104. doi: 10.1161/STROKEAHA.122.039337. Epub 2022 Nov 11.
- Derived from this study: PubMed 31394994Yan S, Zhang X, Zhang R, Xu J, Lou M. Early Fibrinogen Depletion and Symptomatic Intracranial Hemorrhage After Reperfusion Therapy. Stroke. 2019 Oct;50(10):2716-2721. doi: 10.1161/STROKEAHA.119.025711. Epub 2019 Aug 9.
- Individual participant dataSharing planned: Undecided
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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.
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 Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 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: looking for participants now, as of the sponsor's last update on 23 Nov 2022. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, Ph.D (13958007213, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale at 90 days (time frame: 90 days). 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 NCT03367286, 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 23 Nov 2022.