Intracerebral HemorrhageNCT02350010
Etiology and Prognostic Risk Factors of Intracerebral Hemorrhage in Beijing
An observational study of Intracerebral Hemorrhage, run by Beijing Neurosurgical Institute at 1 site in China.
Trial summary
There were lack of data and analysis about medical management, etiology, and long-term outcome of Intracerebral Hemorrhage (ICH) in Beijing. In this study the investigators do acute CT angiography, a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- CT Angiography
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Mar 2017
- 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: Patients admitted with CT-demonstrated Intracerebral Hemorrhage (ICH) within 72 hours after symptom onset.
Who may be able to join
- CT demonstrated ICH
- Age above 18
- within 72 hours of symptom onset
- Informed consent from patient or proxy
Who cannot join
- allergy to contrast medium incompletion of a standard CT protocol including noncontrast CT (NCCT) and CTA Lack of informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Neurosurgical Institute
Beijing, Beijing Municipality, 100000
Hai-Xin Sun, doctor, 0086-010-67058731, sunhaixin2003@163.com
Wen-Zhi Wang, professor, 0086-010-65112838, qgnfbwwz@163.com
About this study
Official title: The Research of Etiology and Risk Factors Related to Prognosis of Intracerebral Hemorrhage in Beijing
There were lack of data and analysis about medical management, etiology, and long-term outcome of Intracerebral Hemorrhage (ICH) in Beijing. In this study the investigators do acute CT angiography, a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Further the investigators will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH.
Read the detailed description
Intracerebral hemorrhage (ICH) accounts for 10 %-15 % of all strokes and is one of leading causes of stroke related mortality and morbidity worldwide. Despite advances in medical knowledge, treatment for ICH remains strictly supportive. ICH accounted for 26.7～51.5% of stroke in China, the proportion was higher than in Western countries. There were lack of data and analysis about medical management, etiology, and long-term outcome of ICH in Beijing.
In this study we do acute CT angiography (CTA), a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Further we will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH. There are some studies of CTA to assess the cause of ICH and functional outcomes, but lack of multi-center, large sample studies to support and validate these findings, particularly fewer application of postcontrast CT. This would allow an early intervention base on different causes and Select treatment decisions according to risk score.
We are planning to:
When patients with ICH arrive in stroke department of the topic cooperation hospitals within 72 hours after symptom onset, they will be subject to CTA with the protocoled sequences.
Standard sequences: Pre- and postcontrast head imaging is acquired from the skull base to vertex with parameters: 120 kVp; 340 mA; 4x5 mm collimation; 1second/rotation; and a table speed of 15 mm/rotation. CTA was performed immediately after initial noncontrast CT(NCCT) performance using a bolus-tracking method by injecting 90 mL of nonionic iodinated contrast (OPTIRAY 350) at 5 mL/s. The protocol for the circle of Willis was 120 kVp, 360 mAs, 0.5 second/rotation, 0.75 mm thick with a pitch of 0.65. Postprocessing procedure including multiplanar reconstruction was performed by a CT technologist at the CT operator's discretion for assessment of contrast extravagation and etiologies of ICH such as vascular malformation, and venous sinus thrombosis. Coronal and sagittal multiplanar reconstructed images were created as 10.0-mm-thick images spaced by 3 mm. Axial reformed images were 4 mm thick with 2-mm spacing.
Clinical data of patients with ICH will be collected by 2 neurologists blinded to the radiological data during patients' hospitalization and at the 3-month, 6-month, and 1-year follow-up. The collected demographic and clinical variables included gender, age, body mass index, alcohol and tobacco use, history of hypertension, diabetes, hyperlipidemia, stroke, coronary heart disease, and medications (antihypertensive, antiplatelet, and anticoagulation agents). The systolic and diastolic blood pressure of patients will be recorded. Stroke severity on admission will be evaluated by Glasgow Coma Scale and National Institutes of Health Stroke Scale. Laboratory tests on admission included white blood cell count, hemoglobin, platelet count, serum glucose, serum creatinine, fibrinogen, activated partial thromboplastin time, and prothrombin time as expressed by the international normalized ratio. Length of hospital stay was recorded. The patients' clinical outcome will be assessed by modified Rankin Scale on discharge and 30-day, 3-month, 6-month, and 1-year.
To sum up the purpose of this present study is to explore etiology and prognostic risk factors of ICH by acute CTA and develop and validate a risk score for predicting 1-year functional outcome after ICH.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- CT Angiography
- Keywords
- Etiology, Prognostic risk factors, Intracerebral Hemorrhage, non-invasive imaging, CT angiography
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT AngiographyDevice
CTA Scan with the specified sequences below:
120 kVp, 360 mAs, 0.5 second/rotation, 0.75 mm thick with a pitch of 0.65. Coronal and sagittal multiplanar reconstructed images with 10.0-mm-thick images spaced by 3 mm.
Axial reformed images were 4 mm thick with 2-mm spacing. 90 mL of nonionic iodinated contrast (OPTIRAY 350) at 5 mL/s.
What is being measured
The primary outcome is the main question the study is designed to answer.
one-year functional outcome and mortality of Intracerebral hemorrhage.
Good functional outcome was defined as modified Rankin Scale score (mRS) ≤2.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Beijing Tiantan Hospital, Beijing Shijitan Hospital, Capital Medical University, KaiLuan General Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, People's Hospital of Beijing Daxing District, Beijing Aerospace General Hospital, Beijing Haidian Hospital, Beijing Fangshan District Liangxiang Hospital, The 263 Hospital of PLA, General Hospital of Beijing PLA Military Region, Peking University Aerospace Center Hospital, Beijing Renhe Hospital, Beijing Pinggu District Hospital, Beijing Shuyi Hospital, Beijing Huairou Hospital, Beijing Luhe Hospital, Fu Xing Hospital, Capital Medical University
- Responsible party
- Sponsor
- Investigators
- Wen-Zhi Wang, professor, Study chair, Beijing Neurosurgical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350010
- Sponsor's protocol ID
- D141100000114003
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hemphill JC 3rd, Bonovich DC, Besmertis L, Manley GT, Johnston SC. The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke. 2001 Apr;32(4):891-7. doi: 10.1161/01.str.32.4.891.
PubMed 11283388Hemphill JC 3rd, Farrant M, Neill TA Jr. Prospective validation of the ICH Score for 12-month functional outcome. Neurology. 2009 Oct 6;73(14):1088-94. doi: 10.1212/WNL.0b013e3181b8b332. Epub 2009 Sep 2.
PubMed 19726752Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009 Apr;8(4):355-69. doi: 10.1016/S1474-4422(09)70025-0. Epub 2009 Feb 21.
PubMed 19233729van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.
PubMed 20056489Zhang LF, Yang J, Hong Z, Yuan GG, Zhou BF, Zhao LC, Huang YN, Chen J, Wu YF; Collaborative Group of China Multicenter Study of Cardiovascular Epidemiology. Proportion of different subtypes of stroke in China. Stroke. 2003 Sep;34(9):2091-6. doi: 10.1161/01.STR.0000087149.42294.8C. Epub 2003 Aug 7.
PubMed 12907817Jiang B, Wang WZ, Chen H, Hong Z, Yang QD, Wu SP, Du XL, Bao QJ. Incidence and trends of stroke and its subtypes in China: results from three large cities. Stroke. 2006 Jan;37(1):63-8. doi: 10.1161/01.STR.0000194955.34820.78. Epub 2005 Nov 23.
PubMed 16306469Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messe SR, Mitchell PH, Selim M, Tamargo RJ; American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010 Sep;41(9):2108-29. doi: 10.1161/STR.0b013e3181ec611b. Epub 2010 Jul 22.
PubMed 20651276
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research of Etiology and Risk Factors Related to Prognosis of Intracerebral Hemorrhage in Beijing
- ClinicalTrials.gov ID
- NCT02350010
- Acronym / sponsor ID
- D141100000114003
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Etiology, Prognostic risk factors, Intracerebral Hemorrhage, non-invasive imaging, CT angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Beijing Tiantan Hospital, Beijing Shijitan Hospital, Capital Medical University, KaiLuan General Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, People's Hospital of Beijing Daxing District, Beijing Aerospace General Hospital, Beijing Haidian Hospital, Beijing Fangshan District Liangxiang Hospital, The 263 Hospital of PLA, General Hospital of Beijing PLA Military Region, Peking University Aerospace Center Hospital, Beijing Renhe Hospital, Beijing Pinggu District Hospital, Beijing Shuyi Hospital, Beijing Huairou Hospital, Beijing Luhe Hospital, Fu Xing Hospital, Capital Medical University
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 29 Jan 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.
There were lack of data and analysis about medical management, etiology, and long-term outcome of Intracerebral Hemorrhage (ICH) in Beijing. In this study the investigators do acute CT angiography, a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Further the investigators will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH.
Detailed description
Intracerebral hemorrhage (ICH) accounts for 10 %-15 % of all strokes and is one of leading causes of stroke related mortality and morbidity worldwide. Despite advances in medical knowledge, treatment for ICH remains strictly supportive. ICH accounted for 26.7～51.5% of stroke in China, the proportion was higher than in Western countries. There were lack of data and analysis about medical management, etiology, and long-term outcome of ICH in Beijing.
In this study we do acute CT angiography (CTA), a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Further we will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH. There are some studies of CTA to assess the cause of ICH and functional outcomes, but lack of multi-center, large sample studies to support and validate these findings, particularly fewer application of postcontrast CT. This would allow an early intervention base on different causes and Select treatment decisions according to risk score.
We are planning to:
When patients with ICH arrive in stroke department of the topic cooperation hospitals within 72 hours after symptom onset, they will be subject to CTA with the protocoled sequences.
Standard sequences: Pre- and postcontrast head imaging is acquired from the skull base to vertex with parameters: 120 kVp; 340 mA; 4x5 mm collimation; 1second/rotation; and a table speed of 15 mm/rotation. CTA was performed immediately after initial noncontrast CT(NCCT) performance using a bolus-tracking method by injecting 90 mL of nonionic iodinated contrast (OPTIRAY 350) at 5 mL/s. The protocol for the circle of Willis was 120 kVp, 360 mAs, 0.5 second/rotation, 0.75 mm thick with a pitch of 0.65. Postprocessing procedure including multiplanar reconstruction was performed by a CT technologist at the CT operator's discretion for assessment of contrast extravagation and etiologies of ICH such as vascular malformation, and venous sinus thrombosis. Coronal and sagittal multiplanar reconstructed images were created as 10.0-mm-thick images spaced by 3 mm. Axial reformed images were 4 mm thick with 2-mm spacing.
Clinical data of patients with ICH will be collected by 2 neurologists blinded to the radiological data during patients' hospitalization and at the 3-month, 6-month, and 1-year follow-up. The collected demographic and clinical variables included gender, age, body mass index, alcohol and tobacco use, history of hypertension, diabetes, hyperlipidemia, stroke, coronary heart disease, and medications (antihypertensive, antiplatelet, and anticoagulation agents). The systolic and diastolic blood pressure of patients will be recorded. Stroke severity on admission will be evaluated by Glasgow Coma Scale and National Institutes of Health Stroke Scale. Laboratory tests on admission included white blood cell count, hemoglobin, platelet count, serum glucose, serum creatinine, fibrinogen, activated partial thromboplastin time, and prothrombin time as expressed by the international normalized ratio. Length of hospital stay was recorded. The patients' clinical outcome will be assessed by modified Rankin Scale on discharge and 30-day, 3-month, 6-month, and 1-year.
To sum up the purpose of this present study is to explore etiology and prognostic risk factors of ICH by acute CTA and develop and validate a risk score for predicting 1-year functional outcome after ICH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with CT-demonstrated Intracerebral Hemorrhage (ICH) within 72 hours after symptom onset.
Key inclusion criteria (4 listed)
- CT demonstrated ICH
- Age above 18
- within 72 hours of symptom onset
- Informed consent from patient or proxy
Key exclusion criteria (1 listed)
- allergy to contrast medium incompletion of a standard CT protocol including noncontrast CT (NCCT) and CTA Lack of informed consent
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 |
|---|---|---|
| CT AngiographyCTA Scan with the specified sequences below: 120 kVp, 360 mAs, 0.5 second/rotation, 0.75 mm thick with a pitch of 0.65. Coronal and sagittal multiplanar reconstructed images with 10.0-mm-thick images spaced by 3 mm. Axial reformed images were 4 mm thick with 2-mm spacing. 90 mL of nonionic iodinated contrast (OPTIRAY 350) at 5 mL/s. | Device | – |
Primary outcome
one-year functional outcome and mortality of Intracerebral hemorrhage.
Time frame: one year
Good functional outcome was defined as modified Rankin Scale score (mRS) ≤2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
- Background: PubMed 11283388Hemphill JC 3rd, Bonovich DC, Besmertis L, Manley GT, Johnston SC. The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke. 2001 Apr;32(4):891-7. doi: 10.1161/01.str.32.4.891.
- Background: PubMed 19726752Hemphill JC 3rd, Farrant M, Neill TA Jr. Prospective validation of the ICH Score for 12-month functional outcome. Neurology. 2009 Oct 6;73(14):1088-94. doi: 10.1212/WNL.0b013e3181b8b332. Epub 2009 Sep 2.
- Background: PubMed 19233729Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009 Apr;8(4):355-69. doi: 10.1016/S1474-4422(09)70025-0. Epub 2009 Feb 21.
- Background: PubMed 20056489van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.
- Background: PubMed 12907817Zhang LF, Yang J, Hong Z, Yuan GG, Zhou BF, Zhao LC, Huang YN, Chen J, Wu YF; Collaborative Group of China Multicenter Study of Cardiovascular Epidemiology. Proportion of different subtypes of stroke in China. Stroke. 2003 Sep;34(9):2091-6. doi: 10.1161/01.STR.0000087149.42294.8C. Epub 2003 Aug 7.
- Background: PubMed 16306469Jiang B, Wang WZ, Chen H, Hong Z, Yang QD, Wu SP, Du XL, Bao QJ. Incidence and trends of stroke and its subtypes in China: results from three large cities. Stroke. 2006 Jan;37(1):63-8. doi: 10.1161/01.STR.0000194955.34820.78. Epub 2005 Nov 23.
- Background: PubMed 20651276Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messe SR, Mitchell PH, Selim M, Tamargo RJ; American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010 Sep;41(9):2108-29. doi: 10.1161/STR.0b013e3181ec611b. Epub 2010 Jul 22.
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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.
Wen-Zhi Wang, professor study chair
Beijing Neurosurgical Institute
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 Intracerebral Hemorrhage, run by Beijing Neurosurgical Institute 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 4 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 29 Jan 2015. 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 Wen-Zhi Wang, professor (0086-010-65112838, qgnfbwwz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one-year functional outcome and mortality of Intracerebral hemorrhage. (time frame: one year). 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 NCT02350010, which also lists 7 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 29 Jan 2015.