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CTedHI
Cranial Temperature, as an Early Diagnosis Marker for Hemorrhagic and Ischemic Stroke
Sponsor study identifier
observational
60
1 country
1
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2015
Actual (reported)November 10, 2015
Actual (reported)May 2016
Date type not reportedThis date has not been verified as actual or estimated.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Diagnose accordance rate
This evaluation will be based on how accordant ischemic stroke diagnosis by cranial temperature compared with imaging examination.
24 hours
Diagnose accordance rate
14 days
The patients in the group are diagnosed as ischemic stroke by CT or MRA examination within 8h following stroke attack.
The patients in the group are diagnosed as hemorrhagic stroke by CT or MRA examination within 8h following stroke attack.
The patients with a symptom and sign of acute stroke admitted to a specialized stroke service within 4.5 hours.
the Southwest hospital
Chongqing, Chongqing Municipality, 400038, China
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.
Hemphill 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.
First Submitted
November 7, 2015
First Posted
November 10, 2015
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 21, 2016
Record last verified: 2016-06
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