Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03367286 |
Other study ID # |
CIPPIS |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 30, 2009 |
Est. completion date |
December 30, 2026 |
Study information
Verified date |
November 2022 |
Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
Contact |
Min Lou, Ph.D |
Phone |
13958007213 |
Email |
loumingxc[@]vip.sina.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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.
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.
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:
1. Provision of informed consent;
2. Male and female adults aged 18-80 years old;
3. 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:
1. Standard contraindications to rt-PA;
2. Contraindication to imaging with contrast agents;
3. Pre-stroke mRS score of ≥2 (indicating previous disability);
4. Participation in any investigational study in the previous 30 days;
5. Any terminal illness such that patient would not be expected to survive more than
one-year.