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NCT Number: NCT03670862

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 (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT

Other

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

Primary outcomes

  1. 90-day functional outcome

    Time frame: 90 days after symptom onset

    Assessed by modified Rankin Scale with scores ranging from 0 (no symptoms) to 6 (death)

Secondary outcomes

  1. Final infarction volume

    Time frame: within 30 days after symptom onset

    Finding the predictive value of novel imaging biomarkers/ imaging patterns on final infarction volume

  2. Percentage of Hemorrhagic Transformation

    Time frame: within 7 days after symptom onset

    Symptomatic hemorrhagic transformation after acute ischemic stroke

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Acronym: PROTECT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2018
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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