Ischemic StrokeCTedHINCT02601183
Cranial Temperature Early Diagnose Hemorrhagic and Ischemic Stroke
An observational study of Ischemic Stroke and Hemorrhagic Stroke, run by Third Military Medical University at 1 site in China.
Trial summary
The cerebrovascular diseases can be approximately divided as two types, namely ischemic and hemorrhagic stroke. Intravenous thrombolysis within 3-4.5 hours is highly recommended for acute ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Stroke
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Dec 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with a symptom and sign of acute stroke admitted to a specialized stroke service within 4.5 hours.
Who may be able to join
- 1.Patients aged 18 to 80 years. 2.Supratentorial hypertensive intracerebral hemorrhage diagnosed by head CT or MRI.
- 3.The intracerebral hematoma is more than 10ml. 4.Ischemic stroke diagnosed by head CT or MRI. 5.Unilateral middle cerebral artery occlusion or infarcted volume more than 1/2 of a hemicerebrum.
- 6.The head temperature collection within 4.5 hours following stroke attack. 7.Glasgow Coma Scale between 5-10.
Who cannot join
- 1.the time after stroke attack exceed 4.5 hours. 2.The intracerebral hematoma is less than 10ml. 3.The infarcted volume less than 1/3 of a hemicerebrum. 4.With terminal cerebral hernia. 5.Pregnant women. 6.Serious impaired liver function, coagulation disorders, AIDS, combine other tumor or special condition.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Southwest hospital
Chongqing, Chongqing Municipality, 400038
Yang Jing, Ph,D, 86-023-68754814, cqhl13@163.com
He Laoshi, Ph,D, 86-136-3549-1484, 45195304@qq.com
About this study
Official title: Cranial Temperature, as an Early Diagnosis Marker for Hemorrhagic and Ischemic Stroke
The cerebrovascular diseases can be approximately divided as two types, namely ischemic and hemorrhagic stroke. Intravenous thrombolysis within 3-4.5 hours is highly recommended for acute ischemic stroke patients. But it's difficult to diagnose the ischemic stroke with the hemorrhagic stroke from the early symptoms and signs. It's with high risk of enlarging the hematoma if the patients with hemorrhagic stroke received the thrombolytic drugs. And time cost by CT or MRI examination is likely to responsible for missing the narrow time window and poor prognosis of stroke patients. Consequently, seeking for a noninvasive, rapid, portable and inexpensive diagnosis method which can sensitively distinguish the stroke type before CT or MRI examination would be very helpful in treating the ischemic stroke patients.
Because of the blockage in the cerebral supply artery, the heat from circulatory system will sharply decrease in infracted hemisphere among the ischemic stroke patients. The reduced brain temperature influenced the temperature on the ipsilateral forehead according to the data of our animal and preliminary clinical trial. In contrast, the temperature of the ipsilateral hemisphere showed a mild increase among the ischemic stroke patients in our preliminary experiment. The difference of the temperature tendency on the ipsilateral forehead has a great chance to be an early physical mark.
In our study, 30 ischemic stroke patients and 30 hemorrhagic stroke patients will be recruited. In the process of recruitment, the patients with acute stroke attack in no more than 4.5 hours will be collected the temperature at the five point without head coverage, including ipsilateral tempora, ipsilateral forehead, galbella, contralateral forehead, and contralateral tempora. Then the stroke would be recruited into the ischemic and hemorrhagic group according to the later CT or MRI results in the hospital. The accuracy and sensibility of early brain temperature in distinguishing stroke type would be tested in comparison with the diagnosis of imaging examination.
Read the detailed description
Stroke is the leading cause of morbidity and disability among the aged population around the world, and its incidence is still rising recently. The cerebrovascular diseases can be approximately divided as two types, namely ischemic and hemorrhagic stroke. Their pathophysiological processes and therapeutical strategies are totally different. For hemorrhagic stroke, which takes up about 20% patients with cerebrovascular diseases, there is a lack of valid medical management in the very early stage except surgical hematoma removal. Whereas it's the key management for ischemic stroke to recanalize the occluded artery and restore blood flow before the irreversible brain damage. According the Guidelines for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack, intravenous thrombolysis within 3-4.5 hours is highly recommended for acute ischemic stroke patients. The time window of thrombolysis after ischemic stroke is extremely narrow and greatly affected the patients' outcomes.
Despite the efficacious therapy exists, the rate of successful early thrombolysis is still awfully low, especially in the developing countries. Only 3-5% stroke patients can take advantage of the early thrombolysis. There are two major reasons response for such a low successful thrombolysis rate, including the civilian and some first-aid personnel hasn't mastered the timing of thrombolysis therapy for ischemic stroke. That would be improved by propaganda and education of the stroke knowledge. But what's more critical is the difficulty to diagnose the ischemic stroke with the hemorrhagic stroke from the early symptoms and signs. It's with high risk of enlarging the hematoma if the patients with hemorrhagic stroke received the thrombolytic drugs. For this reason, it's hard for the doctors to provide the correct treatment at the first time before imaging examination finished. And the time cost by CT or MRI examination is likely to responsible for missing the narrow time window and poor prognosis of stroke patients. Consequently, seeking for a noninvasive, rapid, portable and inexpensive diagnosis method which can sensitively distinguish the stroke type before CT or MRI examination would be very helpful in treating the ischemic stroke patients. The new method would enable the first-aid personnel to judge the stroke type in the ambulance and decide to apply intravenous thrombolysis or not.
Because of the blockage in the cerebral supply artery, especially the cerebral middle artery which can't be compensated, the blood flow in the corresponding hemisphere would drop sharply among the ischemic stroke patients. Along with decreasing heat from circulatory system, the infracted hemisphere's temperature should drop. The reduced brain temperature influenced the temperature on the ipsilateral forehead according to the data of our animal and preliminary clinical trial. In contrast, the temperature of the ipsilateral hemisphere showed a mild increase among the ischemic stroke patients in our preliminary experiment. That's possibly because the early mitochondrial dysfunction and inflammatory reaction induced by the hematoma. The difference of the temperature tendency on the ipsilateral forehead has a great chance to be an early physical mark. Temperature test could be rapid and noninvasive, making this mark a promising method to help the doctors to distinguish the stroke type in very early stage. Earlier diagnosis of ischemic stroke means earlier thrombolysis and much better prognosis.
In our study, 30 ischemic stroke patients and 30 hemorrhagic stroke patients will be recruited. In the process of recruitment, the patients with acute stroke attack in no more than 4.5 hours will be collected the temperature at the five point without head coverage, including ipsilateral tempora, ipsilateral forehead, galbella, contralateral forehead, and contralateral tempora. Then the stroke would be recruited into the ischemic and hemorrhagic group according to the later CT or MRI results in the hospital. The accuracy and sensibility of early brain temperature in distinguishing stroke type would be tested in comparison with the diagnosis of imaging examination. It should be emphasized that the diagnosis and following treatment should depend on the imaging examination and our brain temperature test is rapid and noninvasive. The therapy of the recruited stroke patients wouldn't be influenced by the trial and should be as usual as the standard therapy.
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- brain temperture,thrombolysis,early diagnosis
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic stroke | The patients in the group are diagnosed as ischemic stroke by CT or MRA examination within 8h following stroke attack. | |
| Hemorrhagic stroke | The patients in the group are diagnosed as hemorrhagic stroke by CT or MRA examination within 8h following stroke attack. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnose accordance rate
This evaluation will be based on how accordant ischemic stroke diagnosis by cranial temperature compared with imaging examination.
Measured: 24 hours
Secondary outcomes (1)
Diagnose accordance rate
This evaluation will be based on how accordant ischemic stroke diagnosis by cranial temperature compared with later clinical diagnosis.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startMay 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Liang, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601183
- Sponsor's protocol ID
- ThirdMMU-tl
- Acronym
- CTedHI
- Status last verified
- Jun 2016
- First submitted
- 7 Nov 2015
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.
PubMed 24788967Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.
PubMed 26022637
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Temperature, as an Early Diagnosis Marker for Hemorrhagic and Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02601183
- Acronym / sponsor ID
- CTedHI / ThirdMMU-tl
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- brain temperture,thrombolysis,early diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Nov 2015 (estimated)
- 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.
The cerebrovascular diseases can be approximately divided as two types, namely ischemic and hemorrhagic stroke. Intravenous thrombolysis within 3-4.5 hours is highly recommended for acute ischemic stroke patients. But it's difficult to diagnose the ischemic stroke with the hemorrhagic stroke from the early symptoms and signs. It's with high risk of enlarging the hematoma if the patients with hemorrhagic stroke received the thrombolytic drugs. And time cost by CT or MRI examination is likely to responsible for missing the narrow time window and poor prognosis of stroke patients. Consequently, seeking for a noninvasive, rapid, portable and inexpensive diagnosis method which can sensitively distinguish the stroke type before CT or MRI examination would be very helpful in treating the ischemic stroke patients.
Because of the blockage in the cerebral supply artery, the heat from circulatory system will sharply decrease in infracted hemisphere among the ischemic stroke patients. The reduced brain temperature influenced the temperature on the ipsilateral forehead according to the data of our animal and preliminary clinical trial. In contrast, the temperature of the ipsilateral hemisphere showed a mild increase among the ischemic stroke patients in our preliminary experiment. The difference of the temperature tendency on the ipsilateral forehead has a great chance to be an early physical mark.
In our study, 30 ischemic stroke patients and 30 hemorrhagic stroke patients will be recruited. In the process of recruitment, the patients with acute stroke attack in no more than 4.5 hours will be collected the temperature at the five point without head coverage, including ipsilateral tempora, ipsilateral forehead, galbella, contralateral forehead, and contralateral tempora. Then the stroke would be recruited into the ischemic and hemorrhagic group according to the later CT or MRI results in the hospital. The accuracy and sensibility of early brain temperature in distinguishing stroke type would be tested in comparison with the diagnosis of imaging examination.
Detailed description
Stroke is the leading cause of morbidity and disability among the aged population around the world, and its incidence is still rising recently. The cerebrovascular diseases can be approximately divided as two types, namely ischemic and hemorrhagic stroke. Their pathophysiological processes and therapeutical strategies are totally different. For hemorrhagic stroke, which takes up about 20% patients with cerebrovascular diseases, there is a lack of valid medical management in the very early stage except surgical hematoma removal. Whereas it's the key management for ischemic stroke to recanalize the occluded artery and restore blood flow before the irreversible brain damage. According the Guidelines for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack, intravenous thrombolysis within 3-4.5 hours is highly recommended for acute ischemic stroke patients. The time window of thrombolysis after ischemic stroke is extremely narrow and greatly affected the patients' outcomes.
Despite the efficacious therapy exists, the rate of successful early thrombolysis is still awfully low, especially in the developing countries. Only 3-5% stroke patients can take advantage of the early thrombolysis. There are two major reasons response for such a low successful thrombolysis rate, including the civilian and some first-aid personnel hasn't mastered the timing of thrombolysis therapy for ischemic stroke. That would be improved by propaganda and education of the stroke knowledge. But what's more critical is the difficulty to diagnose the ischemic stroke with the hemorrhagic stroke from the early symptoms and signs. It's with high risk of enlarging the hematoma if the patients with hemorrhagic stroke received the thrombolytic drugs. For this reason, it's hard for the doctors to provide the correct treatment at the first time before imaging examination finished. And the time cost by CT or MRI examination is likely to responsible for missing the narrow time window and poor prognosis of stroke patients. Consequently, seeking for a noninvasive, rapid, portable and inexpensive diagnosis method which can sensitively distinguish the stroke type before CT or MRI examination would be very helpful in treating the ischemic stroke patients. The new method would enable the first-aid personnel to judge the stroke type in the ambulance and decide to apply intravenous thrombolysis or not.
Because of the blockage in the cerebral supply artery, especially the cerebral middle artery which can't be compensated, the blood flow in the corresponding hemisphere would drop sharply among the ischemic stroke patients. Along with decreasing heat from circulatory system, the infracted hemisphere's temperature should drop. The reduced brain temperature influenced the temperature on the ipsilateral forehead according to the data of our animal and preliminary clinical trial. In contrast, the temperature of the ipsilateral hemisphere showed a mild increase among the ischemic stroke patients in our preliminary experiment. That's possibly because the early mitochondrial dysfunction and inflammatory reaction induced by the hematoma. The difference of the temperature tendency on the ipsilateral forehead has a great chance to be an early physical mark. Temperature test could be rapid and noninvasive, making this mark a promising method to help the doctors to distinguish the stroke type in very early stage. Earlier diagnosis of ischemic stroke means earlier thrombolysis and much better prognosis.
In our study, 30 ischemic stroke patients and 30 hemorrhagic stroke patients will be recruited. In the process of recruitment, the patients with acute stroke attack in no more than 4.5 hours will be collected the temperature at the five point without head coverage, including ipsilateral tempora, ipsilateral forehead, galbella, contralateral forehead, and contralateral tempora. Then the stroke would be recruited into the ischemic and hemorrhagic group according to the later CT or MRI results in the hospital. The accuracy and sensibility of early brain temperature in distinguishing stroke type would be tested in comparison with the diagnosis of imaging examination. It should be emphasized that the diagnosis and following treatment should depend on the imaging examination and our brain temperature test is rapid and noninvasive. The therapy of the recruited stroke patients wouldn't be influenced by the trial and should be as usual as the standard therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke | – | –The patients in the group are diagnosed as ischemic stroke by CT or MRA examination within 8h following stroke attack. |
| Hemorrhagic stroke | – | –The patients in the group are diagnosed as hemorrhagic stroke by CT or MRA examination within 8h following stroke attack. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with a symptom and sign of acute stroke admitted to a specialized stroke service within 4.5 hours.
Key inclusion criteria (3 listed)
- 1.Patients aged 18 to 80 years. 2.Supratentorial hypertensive intracerebral hemorrhage diagnosed by head CT or MRI.
- 3.The intracerebral hematoma is more than 10ml. 4.Ischemic stroke diagnosed by head CT or MRI. 5.Unilateral middle cerebral artery occlusion or infarcted volume more than 1/2 of a hemicerebrum.
- 6.The head temperature collection within 4.5 hours following stroke attack. 7.Glasgow Coma Scale between 5-10.
Key exclusion criteria (1 listed)
- 1.the time after stroke attack exceed 4.5 hours. 2.The intracerebral hematoma is less than 10ml. 3.The infarcted volume less than 1/3 of a hemicerebrum. 4.With terminal cerebral hernia. 5.Pregnant women. 6.Serious impaired liver function, coagulation disorders, AIDS, combine other tumor or special condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnose accordance rate
Time frame: 24 hours
This evaluation will be based on how accordant ischemic stroke diagnosis by cranial temperature compared with imaging examination.
1 secondary outcome
Diagnose accordance rate
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Background: PubMed 24788967Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.
- Background: PubMed 26022637Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.
- Individual participant dataSharing planned: Yes
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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.
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 Ischemic Stroke and Hemorrhagic Stroke, run by Third Military Medical University 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 1 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: status not confirmed, as of the sponsor's last update on 21 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Hua, Ph.D,MD (86-137-0832-1681, fenghua8888@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnose accordance rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02601183, which also lists 2 linked publications.
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 21 Jun 2016.