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Prediction Model for the Recanalization OuTcome Evaluation of Ischemic Stroke Using Multimodal CT

Prediction Model for the Recanalization Outcome Evaluation of Ischemic Stroke Using Multimodal CT

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03670862
Acronym
PROTECT
Enrollment
862
Registered
2018-09-14
Start date
2019-01-01
Completion date
2021-03-30
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Acute

Keywords

Ischemic stroke, CTP, CTA

Brief 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.

Detailed 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.

Interventions

OTHERCT

Non-contrast computed tomography , computed tomography angiography, computed tomography perfusion imaging

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cerebral ischemic sympton with onset in 24 hours * All CT examination performed according to study protocol * Signed informed consent obtained from the patient or patient's legally authorized representative

Exclusion criteria

* Acute intracranial hemorrhage * Pre-existing medical, the neurological, or psychiatric disease that would confound the neurological, functional, or imaging evaluations * Pregnancy * Known allergy to iodine previously refractory to pretreatment medications * Renal Failure (serum creatinine \> 2.0 or Glomerular Filtration Rate \< 30) * History of severe kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure * Severe cardiac insufficiency

Design outcomes

Primary

MeasureTime frameDescription
90-day functional outcome90 days after symptom onsetAssessed by modified Rankin Scale with scores ranging from 0 (no symptoms) to 6 (death)

Secondary

MeasureTime frameDescription
Final infarction volumewithin 30 days after symptom onsetFinding the predictive value of novel imaging biomarkers/ imaging patterns on final infarction volume
Percentage of Hemorrhagic Transformationwithin 7 days after symptom onsetSymptomatic hemorrhagic transformation after acute ischemic stroke

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026