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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03670862
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Xin Lou, Chinese PLA General Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Stroke, Acute Other: CT

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.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 862 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Prediction Model for the Recanalization Outcome Evaluation of Ischemic Stroke Using Multimodal CT
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : March 30, 2021
Actual Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Groups and Cohorts
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Group/Cohort Intervention/treatment
stroke
Ischemic stroke patients with sympton onset in 24 hours
 Other: CT
Non-contrast computed tomography , computed tomography angiography, computed tomography perfusion imaging


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Ischemic stroke patients with sympton onset in 24 hours
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670862


Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Chair: Xin Lou, M.D.,Ph.D. Chinese PLA General Hospital
More Information
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Additional Information:

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Responsible Party: Xin Lou, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03670862    
Other Study ID Numbers: PROTECT-ChinaPLAGH
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xin Lou, Chinese PLA General Hospital:
Ischemic stroke
CTP
CTA
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases