Stroke, AcutePROTECTNCT03670862
Prediction Model for the Recanalization OuTcome Evaluation of Ischemic Stroke Using Multimodal CT
An observational study of Stroke, Acute, run by Chinese PLA General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- CT
- How many people
- 862 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Mar 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic stroke patients with sympton onset in 24 hours
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Acute
- Being tested
- CT
- Keywords
- Ischemic stroke, CTP, CTA
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTOther
Non-contrast computed tomography , computed tomography angiography, computed tomography perfusion imaging
| Study group | Role | What they receive |
|---|---|---|
| stroke | Ischemic stroke patients with sympton onset in 24 hours Receives: Other: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day functional outcome
Assessed by modified Rankin Scale with scores ranging from 0 (no symptoms) to 6 (death)
Measured: 90 days after symptom onset
Secondary outcomes (2)
Final infarction volume
Finding the predictive value of novel imaging biomarkers/ imaging patterns on final infarction volume
Measured: within 30 days after symptom onset
Percentage of Hemorrhagic Transformation
Symptomatic hemorrhagic transformation after acute ischemic stroke
Measured: within 7 days after symptom onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Jan 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 862 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, M.D.,Ph.D., Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670862
- Sponsor's protocol ID
- PROTECT-ChinaPLAGH
- Acronym
- PROTECT
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2018
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model for the Recanalization Outcome Evaluation of Ischemic Stroke Using Multimodal CT
- ClinicalTrials.gov ID
- NCT03670862
- Acronym / sponsor ID
- PROTECT / PROTECT-ChinaPLAGH
- Conditions
- Stroke, Acute
- Keywords
- Ischemic stroke, CTP, CTA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 862 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke | – | Other: CTIschemic stroke patients with sympton onset in 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic stroke patients with sympton onset in 24 hours
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTNon-contrast computed tomography , computed tomography angiography, computed tomography perfusion imaging | Other | stroke |
Primary outcome
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)
2 secondary outcomes
Final infarction volume
Time frame: within 30 days after symptom onset
Percentage of Hemorrhagic Transformation
Time frame: within 7 days after symptom onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Lou, M.D.,Ph.D. study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day functional outcome (time frame: 90 days after symptom onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.