Cranial Temperature Early Diagnose Hemorrhagic and Ischemic Stroke

NCT02601183 | Unknown DMC

• 1 other identifier: ThirdMMU-tl
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Keywords

brain temperture，thrombolysis，early diagnosis

Outcome Measures

Primary Outcomes (1)

• Diagnose accordance rate

  This evaluation will be based on how accordant ischemic stroke diagnosis by cranial temperature compared with imaging examination.

  24 hours

Secondary Outcomes (1)

• Diagnose accordance rate

  14 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with a symptom and sign of acute stroke admitted to a specialized stroke service within 4.5 hours.

You may qualify if:

• Patients aged 18 to 80 years. 2.Supratentorial hypertensive intracerebral hemorrhage diagnosed by head CT or MRI.
• 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.
• The head temperature collection within 4.5 hours following stroke attack. 7.Glasgow Coma Scale between 5-10.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

the Southwest hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 24788967 BACKGROUND

• 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.

  PMID: 26022637 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Feng Hua, Ph.D,MD

CONTACT

86-137-0832-1681; fenghua8888@aliyun.com

Tan Liang, MD

CONTACT

86-158-2354-0630; tracy200712@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Southwest hospital

Study Record Dates

• First Submitted: November 7, 2015
• First Posted: November 10, 2015
• Study Start: May 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: June 21, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)