Cranial Temperature Early Diagnose Hemorrhagic and Ischemic Stroke (CTedHI)

June 19, 2016 updated by: Tan Liang, Third Military Medical University

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • the southwest Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Feng Hua, Ph,D MD
        • Sub-Investigator:
          • Tan Liang, MD
        • Sub-Investigator:
          • Chen Weixiang, MD
        • Sub-Investigator:
          • Ma Kang, MD
        • Principal Investigator:
          • Liu Xin, Ph,D
        • Sub-Investigator:
          • Zhang Yangqi, Ph,D
        • Sub-Investigator:
          • Hu Rong, MD
        • Sub-Investigator:
          • Zhou Zhenghua, MD
        • Sub-Investigator:
          • Ren Xiaobao, MD
        • Sub-Investigator:
          • Rong Yuan, MD
        • Sub-Investigator:
          • Zhang Yi, MD
        • Sub-Investigator:
          • Chen Lin, MD
        • Sub-Investigator:
          • Huang Yi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnose accordance rate
Time Frame: 14 days
This evaluation will be based on how accordant ischemic stroke diagnosis by cranial temperature compared with later clinical diagnosis.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 7, 2015

First Submitted That Met QC Criteria

November 7, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 19, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ThirdMMU-tl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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