Etiology and Prognostic Risk Factors of Intracerebral Hemorrhage in Beijing

Intracerebral Hemorrhage Clinical Trial

Official title:

The Research of Etiology and Risk Factors Related to Prognosis of Intracerebral Hemorrhage in Beijing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02350010
• Other study ID #: D141100000114003
• Status: Not yet recruiting
• Phase: N/A
• First received: January 7, 2015
• Last updated: January 26, 2015
• Start date: January 2015
• Est. completion date: March 2017

Study information

• Verified date: January 2015
• Source: Beijing Neurosurgical Institute
• Contact: Wen-Zhi Wang, professor
• Phone: 0086-010-65112838
• Email: qgnfbwwz[@]163.com
• Is FDA regulated: No
• Health authority: China:Beijing TeSMO Company
• Study type: Observational

Clinical 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. Further the investigators will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CT demonstrated ICH

• Age above 18

• within 72 hours of symptom onset

• Informed consent from patient or proxy

Exclusion Criteria:

allergy to contrast medium incompletion of a standard CT protocol including noncontrast CT (NCCT) and CTA Lack of informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Device:
• CT Angiography
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.

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute	Beijing	Beijing

Sponsors (19)

Lead Sponsor

Collaborator

Beijing Neurosurgical Institute

Beijing Aerospace General Hospital, Beijing Fangshan District Liangxiang Hospital, Beijing Haidian Hospital, Beijing Huairou District first hospital, Beijing Luhe Hospital, Beijing Pinggu District Hospital, Beijing Renhe Hospital, Beijing Shijitan Hospital, Beijing Shuyi Hospital, Beijing Tiantan Hospital, Fu Xing Hospital, Capital Medical University, General Hospital of Beijing PLA Military Region, KaiLuan General Hospital, Peking University Aerospace Centre Hospital, Peking University Third Hospital, People’s Hospital of Beijing Daxing District, The 263 Hospital of PLA, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (7)

Feigin 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. Review. — View Citation

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. — View Citation

Hemphill 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. — View Citation

Jiang 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. Epub 2005 Nov 23. — View Citation

Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messé 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. — View Citation

van 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. Review. — View Citation

Zhang 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. Epub 2003 Aug 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	one-year functional outcome and mortality of Intracerebral hemorrhage.	Good functional outcome was defined as modified Rankin Scale score (mRS) =2.	one year	Yes