Skip to main content
Top
Published in: BMC Complementary Medicine and Therapies 1/2017

Open Access 01-12-2017 | Study protocol

Chinese acute ischemic stroke treatment outcome registry (CASTOR): protocol for a prospective registry study on patterns of real-world treatment of acute ischemic stroke in China

Authors: Weiping Sun, Qianhua Ou, Zhijun Zhang, Jiazhi Qu, Yining Huang

Published in: BMC Complementary Medicine and Therapies | Issue 1/2017

Login to get access

Abstract

Rationale

Stroke presents a serious health problem in China. Despite progresses made in recent years, there is still a lack of effective treatments for acute ischemic stroke (AIS) in clinical practices.

Aims

The Chinese Acute Ischemic Stroke Treatment Outcome Registry (CASTOR) is designed to evaluate the patterns and cost-effectiveness of current treatments for AIS in real-world settings in China.

Design

CASTOR is a prospective, multi-center study registered with ClinicalTrials.​gov (NCT02470624) with a target sample size of 10,000 patients who are experiencing AIS. The patients are treated for AIS following the Chinese stroke guideline and local practice. Real-world data on treatment regimens, outcomes and costs are collected at baseline (Visit 1) and during subsequent visits (Visit 2 to Visit 5) after medication treatments.

Outcome

The primary objective of the present study is to analyze the current treatment status of AIS in real world settings. The secondary objectives include: 1) to compare the effectiveness of common treatment regimens, 2) to analyze the cost-effectiveness of different treatment regimens for AIS, 3) to analyze the incidence of adverse events and complications in enrolled patients with AIS, 4) to analyze the effect of Trial of Org 10,172 in Acute Stroke Treatment (TOAST) classification on the specific therapies during acute phase treatment period.

Discussion

In face of changing treatment patterns and increasing demand from medical insurers for cost-effectiveness data in China, a large-scale registry study examining the real-world patterns of AIS in hospitals is needed. The CASTOR study will help to find favorable cost-utility treatment regimens for AIS and improve the overall treatment outcome of Chinese patients with AIS.
Appendix
Available only for authorised users
Literature
1.
go back to reference Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S. Heart disease and stroke statistics-2014 update. Circulation. 2014;129(3). Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S. Heart disease and stroke statistics-2014 update. Circulation. 2014;129(3).
2.
go back to reference Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011;42(12):3651–4.CrossRefPubMed Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011;42(12):3651–4.CrossRefPubMed
3.
go back to reference Yang G, Wang Y, Zeng Y, Gao GF, Liang X, Zhou M, Wan X, Yu S, Jiang Y, Naghavi M, et al. Rapid health transition in China, 1990-2010: findings from the global burden of disease study 2010. Lancet. 2013;381(9882):1987–2015.CrossRefPubMed Yang G, Wang Y, Zeng Y, Gao GF, Liang X, Zhou M, Wan X, Yu S, Jiang Y, Naghavi M, et al. Rapid health transition in China, 1990-2010: findings from the global burden of disease study 2010. Lancet. 2013;381(9882):1987–2015.CrossRefPubMed
4.
go back to reference Wang YJ, Zhang SM, Zhang L, Wang CX, Dong Q, Gao S, Huang RX, Huang YN, Lv CZ, Liu M, et al. Chinese guidelines for the secondary prevention of ischemic stroke and transient ischemic attack 2010. CNS neuroscience & therapeutics. 2012;18(2):93–101.CrossRef Wang YJ, Zhang SM, Zhang L, Wang CX, Dong Q, Gao S, Huang RX, Huang YN, Lv CZ, Liu M, et al. Chinese guidelines for the secondary prevention of ischemic stroke and transient ischemic attack 2010. CNS neuroscience & therapeutics. 2012;18(2):93–101.CrossRef
5.
go back to reference Kolominskyrabas PL, Weber M, Gefeller O, Neundoerfer B, Heuschmann PU: Epidemiology of ischemic stroke subtypes according to TOAST criteria: incidence, recurrence, and long-term survival in ischemic stroke subtypes: a population-based study. 2001;32(12):2735–2740. Kolominskyrabas PL, Weber M, Gefeller O, Neundoerfer B, Heuschmann PU: Epidemiology of ischemic stroke subtypes according to TOAST criteria: incidence, recurrence, and long-term survival in ischemic stroke subtypes: a population-based study. 2001;32(12):2735–2740.
6.
go back to reference Liu M, Wu B, Wang WZ, Lee LM, Zhang SH, Kong LZ. Stroke in China: epidemiology, prevention, and management strategies. The Lancet Neurology. 2007;6(5):456–64.CrossRefPubMed Liu M, Wu B, Wang WZ, Lee LM, Zhang SH, Kong LZ. Stroke in China: epidemiology, prevention, and management strategies. The Lancet Neurology. 2007;6(5):456–64.CrossRefPubMed
7.
go back to reference Chen Z. The third national survey on the cause of death. Ministry of Health, People's Republic of China: Peking Union Medical University Press; 2008. Chen Z. The third national survey on the cause of death. Ministry of Health, People's Republic of China: Peking Union Medical University Press; 2008.
8.
go back to reference Wang C, Li J, Zhao X, Wang Y, Wu D, Wang Y. Stroke care development in mainland China: past, present and future. International journal of stroke: official journal of the International Stroke Society. 2008;3(4):288–9.CrossRef Wang C, Li J, Zhao X, Wang Y, Wu D, Wang Y. Stroke care development in mainland China: past, present and future. International journal of stroke: official journal of the International Stroke Society. 2008;3(4):288–9.CrossRef
9.
go back to reference Chinese Guidelines Revision Committee of Prevention and Treatment for Hypertension. Chinese guidelines of prevention and treatment for hypertension (2005 revision edition). Chin J Hypertens. 2005;13:5–41. Chinese Guidelines Revision Committee of Prevention and Treatment for Hypertension. Chinese guidelines of prevention and treatment for hypertension (2005 revision edition). Chin J Hypertens. 2005;13:5–41.
10.
go back to reference Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008;359(13):1317–29.CrossRefPubMed Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008;359(13):1317–29.CrossRefPubMed
11.
go back to reference Wahlgren N, Ahmed N, Dávalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V. Thrombolysis with alteplase for acute ischaemic stroke in the safe implementation of thrombolysis in stroke-monitoring study (SITS-MOST): an observational study. Lancet. 2007;369(9558):275–82.CrossRefPubMed Wahlgren N, Ahmed N, Dávalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V. Thrombolysis with alteplase for acute ischaemic stroke in the safe implementation of thrombolysis in stroke-monitoring study (SITS-MOST): an observational study. Lancet. 2007;369(9558):275–82.CrossRefPubMed
12.
go back to reference Xydas T, Georgantopoulos C, Bethanis D, Sarris M. Thrombolysis for Acute Ischemic Stroke: a New Paradigm. Hosp Chron. 2012;7(1 Sup):77–80. Xydas T, Georgantopoulos C, Bethanis D, Sarris M. Thrombolysis for Acute Ischemic Stroke: a New Paradigm. Hosp Chron. 2012;7(1 Sup):77–80.
13.
go back to reference 95s' Project: Intravenous thrombolysis with urokinase for acute cerebral infarctions. Chin J Neurol. 2002;35(4):210–213. 95s' Project: Intravenous thrombolysis with urokinase for acute cerebral infarctions. Chin J Neurol. 2002;35(4):210–213.
14.
go back to reference Heuschmann PU, Kolominskyrabas PL, Roether J, Misselwitz B, Lowitzsch K, Heidrich J, Hermanek P, Leffmann C, Sitzer M, Biegler M. Predictors of in-hospital mortality in patients with acute ischemic stroke treated with thrombolytic therapy. JAMA. 2004;14(1):1831.CrossRef Heuschmann PU, Kolominskyrabas PL, Roether J, Misselwitz B, Lowitzsch K, Heidrich J, Hermanek P, Leffmann C, Sitzer M, Biegler M. Predictors of in-hospital mortality in patients with acute ischemic stroke treated with thrombolytic therapy. JAMA. 2004;14(1):1831.CrossRef
15.
go back to reference Minnerup J, Wersching H, Teuber A, Wellmann J, Eyding J, Weber R, Reimann G, Weber W, Krause LU, Kurth T. Outcome after Thrombectomy and intravenous thrombolysis in patients with acute ischemic stroke: a prospective observational study. Stroke. 2016;47(6):1584.CrossRefPubMed Minnerup J, Wersching H, Teuber A, Wellmann J, Eyding J, Weber R, Reimann G, Weber W, Krause LU, Kurth T. Outcome after Thrombectomy and intravenous thrombolysis in patients with acute ischemic stroke: a prospective observational study. Stroke. 2016;47(6):1584.CrossRefPubMed
16.
go back to reference Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W. Stent-retriever Thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015;372(24):2285–95.CrossRefPubMed Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W. Stent-retriever Thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015;372(24):2285–95.CrossRefPubMed
17.
go back to reference Berkhemer OA, Fransen PS, Beumer D, La VDB, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015;372(1):11.CrossRefPubMed Berkhemer OA, Fransen PS, Beumer D, La VDB, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015;372(1):11.CrossRefPubMed
18.
go back to reference Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015;372(11):1009–18.CrossRefPubMed Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015;372(11):1009–18.CrossRefPubMed
19.
go back to reference Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015;372(11):1019.CrossRefPubMed Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015;372(11):1019.CrossRefPubMed
20.
go back to reference Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San RL, Serena J, Abilleira S, Ribó M. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015;372(24):2296–306.CrossRefPubMed Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San RL, Serena J, Abilleira S, Ribó M. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015;372(24):2296–306.CrossRefPubMed
21.
go back to reference Wang Y, Cui L, Ji X, Dong Q, Zeng J, Wang Y, Zhou Y, Zhao X, Wang C, Liu L, et al. The China National Stroke Registry for patients with acute cerebrovascular events: design, rationale, and baseline patient characteristics. International journal of stroke : official journal of the International Stroke Society. 2011;6(4):355–61.CrossRef Wang Y, Cui L, Ji X, Dong Q, Zeng J, Wang Y, Zhou Y, Zhao X, Wang C, Liu L, et al. The China National Stroke Registry for patients with acute cerebrovascular events: design, rationale, and baseline patient characteristics. International journal of stroke : official journal of the International Stroke Society. 2011;6(4):355–61.CrossRef
22.
go back to reference Wang X, Wang Y, Wang C, Zhao X, Xian Y, Wang D, Liu L, Luo Y, Liu G, Wang Y. Association between estimated glomerular filtration rate and clinical outcomes in patients with acute ischaemic stroke: results from China national stroke registry. Age Ageing. 2014;43(6):839–45.CrossRefPubMed Wang X, Wang Y, Wang C, Zhao X, Xian Y, Wang D, Liu L, Luo Y, Liu G, Wang Y. Association between estimated glomerular filtration rate and clinical outcomes in patients with acute ischaemic stroke: results from China national stroke registry. Age Ageing. 2014;43(6):839–45.CrossRefPubMed
23.
go back to reference Meng X, Chen Y, Jing J, Zhao X, Wang C, Liu L, Wang A, Pan Y, Li C, Wang Y. Association between polyvascular atherosclerosis and estimated glomerular filtration rate in patients with ischaemic stroke: data analysis of the patients in the Chinese national stroke registry. Neurol Res. 2015;37(5):415–20.CrossRefPubMed Meng X, Chen Y, Jing J, Zhao X, Wang C, Liu L, Wang A, Pan Y, Li C, Wang Y. Association between polyvascular atherosclerosis and estimated glomerular filtration rate in patients with ischaemic stroke: data analysis of the patients in the Chinese national stroke registry. Neurol Res. 2015;37(5):415–20.CrossRefPubMed
24.
go back to reference Li Z, Zhao X, Wang Y, Wang C, Liu L, Shao X, Wang W, Pan Y, Wang C, Ji R, et al. Association between seizures and outcomes among intracerebral hemorrhage patients: the China national stroke registry. Journal of stroke and cerebrovascular diseases: the official journal of National Stroke Association. 2015;24(2):455–64.CrossRef Li Z, Zhao X, Wang Y, Wang C, Liu L, Shao X, Wang W, Pan Y, Wang C, Ji R, et al. Association between seizures and outcomes among intracerebral hemorrhage patients: the China national stroke registry. Journal of stroke and cerebrovascular diseases: the official journal of National Stroke Association. 2015;24(2):455–64.CrossRef
25.
go back to reference Luo Y, Wang X, Wang Y, Wang C, Wang H, Wang D, Liu L, Jia Q, Liu G, Zhao X, et al. Association of glomerular filtration rate with outcomes of acute stroke in type 2 diabetic patients: results from the China national stroke registry. Diabetes Care. 2014;37(1):173–9.CrossRefPubMed Luo Y, Wang X, Wang Y, Wang C, Wang H, Wang D, Liu L, Jia Q, Liu G, Zhao X, et al. Association of glomerular filtration rate with outcomes of acute stroke in type 2 diabetic patients: results from the China national stroke registry. Diabetes Care. 2014;37(1):173–9.CrossRefPubMed
26.
go back to reference Jia Q, Zhao X, Wang C, Wang Y, Yan Y, Li H, Zhong L, Liu L, Zheng H, Zhou Y, et al. Diabetes and poor outcomes within 6 months after acute ischemic stroke: the China National Stroke Registry. Stroke. 2011;42(10):2758–62.CrossRefPubMed Jia Q, Zhao X, Wang C, Wang Y, Yan Y, Li H, Zhong L, Liu L, Zheng H, Zhou Y, et al. Diabetes and poor outcomes within 6 months after acute ischemic stroke: the China National Stroke Registry. Stroke. 2011;42(10):2758–62.CrossRefPubMed
27.
go back to reference Chinese Society of Neurology. Cerebrovascular disease Group of the Chinese Society of neurology: Chinese guidelines of diagnosis and treatment for acute ischemic stroke (2014). Chin J Neurol. 2015;48(4):246–57. Chinese Society of Neurology. Cerebrovascular disease Group of the Chinese Society of neurology: Chinese guidelines of diagnosis and treatment for acute ischemic stroke (2014). Chin J Neurol. 2015;48(4):246–57.
28.
go back to reference Phillips C, Thompson G. What is QALY? (second edition). Health Econ. 2009;1:400–5. Phillips C, Thompson G. What is QALY? (second edition). Health Econ. 2009;1:400–5.
29.
go back to reference Shi R, Zhang R, Yang F, Lin M, Li M, Liu L, Yin Q, Lin H, Xiong Y, Liu W, et al. Tissue Kallikrein prevents restenosis after stenting of severe atherosclerotic stenosis of the middle cerebral artery: a randomized controlled trial. Medicine. 2016;95(6):e2809.CrossRefPubMedPubMedCentral Shi R, Zhang R, Yang F, Lin M, Li M, Liu L, Yin Q, Lin H, Xiong Y, Liu W, et al. Tissue Kallikrein prevents restenosis after stenting of severe atherosclerotic stenosis of the middle cerebral artery: a randomized controlled trial. Medicine. 2016;95(6):e2809.CrossRefPubMedPubMedCentral
Metadata
Title
Chinese acute ischemic stroke treatment outcome registry (CASTOR): protocol for a prospective registry study on patterns of real-world treatment of acute ischemic stroke in China
Authors
Weiping Sun
Qianhua Ou
Zhijun Zhang
Jiazhi Qu
Yining Huang
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2017
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-017-1863-4

Other articles of this Issue 1/2017

BMC Complementary Medicine and Therapies 1/2017 Go to the issue