Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03670862 |
Other study ID # |
PROTECT-ChinaPLAGH |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2019 |
Est. completion date |
March 30, 2021 |
Study information
Verified date |
September 2021 |
Source |
Chinese PLA General Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Prediction model for the Recanalization OuTcome Evaluation of ischemic stroke using
multimodal CT (PROTECT) study was a multicenter prospective observational study that
recruited patients from 13 centers located in 10 provinces across China. The study was to
assess the effects of novel imaging biomarkers/ imaging patterns based on multimodel CT for
patients selection and outcome prediction in acute ischemic stroke.
Description:
Patients Patients with cerebral ischemia symptoms of anterior circulation or posterior
circulation onset in 24 hours were included. A neurological evaluation (Modified Rankin Scale
and NIHSS); physical examination, including measurement of weight (kg) and vital signs
(supine systolic and diastolic blood pressure); time from symptom onset to enrollment were
recorded.
Imaging protocols:
CT scan protocols: Non-contrast computed tomography(NCCT) , computed tomography
angiography(CTA), computed tomography perfusion(CTP)
Contrast agent:
CTA: Omniscan 40-50ml, 5ml/s; saline solution 50ml, 5ml/s
CTP: Omniscan 50ml, 5ml/s; saline solution 50ml, 5ml/s
Imaging evaluation:
CTA was reviewed and stenosis or occlusive lesions were identified. Parameter maps including
cerebral blood flow, cerebral blood volume, mean transit time, the time to the maximum of the
residue function derived from CTP were processed by the software Rapid to quantitatively
assess infarct core volume and mismatch.
Multiphase CTA was extracted from CTP to evaluate the collateral circulation.
Treatment:
Intravenous recombinant tissue plasminogen activator(rtPA), endovascular therapy, and
conventional treatment including neuroprotection, anti-platelet, and statin according to the
guideline.
Follow up:
Modified Rankin Scale(mRS) was obtained at 90 days after symptom onset. An imaging follow-up
was also recommended within 30 days after symptom onset.