Prediction Model for the Recanalization OuTcome Evaluation of Ischemic Stroke Using Multimodal CT
PROTECT
1 other identifier
observational
862
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 14, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedSeptember 20, 2021
September 1, 2021
2.2 years
September 12, 2018
September 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
90-day functional outcome
Assessed by modified Rankin Scale with scores ranging from 0 (no symptoms) to 6 (death)
90 days after symptom onset
Secondary Outcomes (2)
Final infarction volume
within 30 days after symptom onset
Percentage of Hemorrhagic Transformation
within 7 days after symptom onset
Study Arms (1)
stroke
Ischemic stroke patients with sympton onset in 24 hours
Interventions
Non-contrast computed tomography , computed tomography angiography, computed tomography perfusion imaging
Eligibility Criteria
Ischemic stroke patients with sympton onset in 24 hours
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xin Lou, M.D.,Ph.D.
Chinese PLA General Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 12, 2018
First Posted
September 14, 2018
Study Start
January 1, 2019
Primary Completion
March 30, 2021
Study Completion
March 30, 2021
Last Updated
September 20, 2021
Record last verified: 2021-09