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| Name | Class |
|---|---|
| Zhongshan People's Hospital, Guangdong, China | OTHER |
| Kaiping Central Hospital | OTHER |
| Second Affiliated Hospital of Shantou University Medical College | OTHER |
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This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.
This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrombus aspiration | Experimental | Upfront manual thrombus aspiration followed by PCI |
|
| PCI Alone | Active Comparator | PCI without upfront manual thrombus aspiration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombus aspiration | Procedure | Percutaneous Coronary Intervention with manual aspiration thrombectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events | The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization | up to180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke | The symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular | up to 30 days |
| Composite adverse cardiocerebrovascular events | The first occurence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization or stroke. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengchen He, MD | Contact | 86-13829730152 | drhepengcheng@aliyun.co |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Hospital | Not yet recruiting | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6350634 | Background | Herrick JB. Landmark article (JAMA 1912). Clinical features of sudden obstruction of the coronary arteries. By James B. Herrick. JAMA. 1983 Oct 7;250(13):1757-65. No abstract available. | |
| 7412821 | Background | DeWood MA, Spores J, Notske R, Mouser LT, Burroughs R, Golden MS, Lang HT. Prevalence of total coronary occlusion during the early hours of transmural myocardial infarction. N Engl J Med. 1980 Oct 16;303(16):897-902. doi: 10.1056/NEJM198010163031601. |
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| The Third Xiangya Hospital of Central South University |
| OTHER |
| Sihui City People's Hospital | UNKNOWN |
| Shenzhen Baoan District People's Hospital | OTHER |
| People's Hospital of Nanxiong County | UNKNOWN |
| Yuebei People's Hospital | OTHER |
| Weifang Medical University | OTHER |
| Wuzhou Gongren Hospital | UNKNOWN |
| Dafeng Hospital of Chaoyang District in Shantou City | UNKNOWN |
| Dongguan People's Hospital | OTHER_GOV |
| Yangchun People's Hospital | UNKNOWN |
| Taishan People's Hospital | UNKNOWN |
| The Second People's Hospital of Foshan | OTHER |
| Guangzhou Hospital of integrated Traditional and West Medicine | UNKNOWN |
| Guangning People's Hospital | UNKNOWN |
| Foshan Sanshui District People's Hospital | UNKNOWN |
| Qingyuan People's Hospital | OTHER |
| Luhe County People's Hospital | UNKNOWN |
| People's Hospital of Xinjiang Uygur Autonomous Region | OTHER |
| The Fourth People's Hospital of Chenzhou | UNKNOWN |
| People's Hospital of Dapu County | UNKNOWN |
| Shenzhen People's Hospital | OTHER |
| Heyuan people's Hospital | UNKNOWN |
| Huaiji People's Hospital | UNKNOWN |
| People's Hospital of Yingde City | UNKNOWN |
| Zhongshan Hospital Of Traditional Chinese Medicine | OTHER |
| The Third Affiliated Hospital of Guangzhou Medical University | OTHER |
| Lianzhou People's Hospital | UNKNOWN |
| Lianping Xian Ren Ming Yi Yuan | UNKNOWN |
| Guangxi Zhuang Autonomous Region Nationalities Hospital | UNKNOWN |
| Liuzhou Municipal Liutie Central Hospital | UNKNOWN |
| Chen Zhou 3RD People's Hospital | UNKNOWN |
| Longgang District People's Hospital of Shenzhen | OTHER |
| The Affiliated Shunde Hospital of Jinan University | UNKNOWN |
| Shenzhen Longhua District Central Hospital | UNKNOWN |
| Shantou Central Hospital | OTHER |
| Tongxiang First People's Hospital | UNKNOWN |
| Bobai County People's Hospital, Guangxi | UNKNOWN |
| Meizhou Traditional Chinese Medicine Hospital | UNKNOWN |
| The Third Affiliated Hospital of Sun Yat-Sen University, Yuedong Hospital | UNKNOWN |
| Shenzhen Third People's Hospital | OTHER |
| Yangjiang People's Hospital | OTHER |
| Jiangmen Central Hospital | OTHER |
| Eighth Affiliated Hospital, Sun Yat-sen University | OTHER |
| The First People's Hospital of Kashgar Erea | UNKNOWN |
| First People's Hospital of Foshan | OTHER |
| Zhaoqing Gaoyao People's Hospital | UNKNOWN |
| People's Hospital of Nanhai District, Foshan | UNKNOWN |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| Nanning Second People's Hospital | OTHER |
| The Second People's Hospital of Nanhai District of Foshan | UNKNOWN |
| Shangyou People's Hospital | UNKNOWN |
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| PCI Alone | Procedure | Percutaneous Coronary Intervention without manual aspiration thrombectomy |
|
| up to 1 year |
| First People's Hospital of Foshan | Not yet recruiting | Foshan | Guangdong | 528000 | China |
|
| The Second People's Hospital of Nanhai District | Recruiting | Foshan | Guangdong | 528251 | China |
|
| First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University) | Not yet recruiting | Foshan | Guangdong | 528300 | China |
|
| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | Guangdong | 510000 | China |
|
| Guangzhou Panyu Central Hospital | Not yet recruiting | Guangzhou | Guangdong | 510000 | China |
|
| Guangzhou General Hospital of Guangzhou Military Command | Not yet recruiting | Guangzhou | Guangdong | 510010 | China |
|
| The first Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
|
| Guangdong Provincial Hospital of traditional Chinese Medicine | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
|
| The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
|
| The Second Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting | Guangzhou | Guangdong | 510235 | China |
|
| Zhujiang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510280 | China |
|
| Nanfang Hospital | Not yet recruiting | Guangzhou | Guangdong | 510515 | China |
|
| Huangpu Division of The First Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510700 | China |
|
| Huadu District People's Hospital of Guangzhou | Not yet recruiting | Guangzhou | Guangdong | 510800 | China |
|
| Huizhou Third People's Hospital | Not yet recruiting | Huizhou | Guangdong | 516002 | China |
|
| Jiangmen Central Hospital | Not yet recruiting | Jiangmen | Guangdong | 529030 | China |
|
| Kaiping Central Hospital | Recruiting | Kaiping | Guangdong | 529300 | China |
| Maoming People's Hospital | Not yet recruiting | Maoming | Guangdong | 525000 | China |
|
| The Second Affiliated Hospital of Shantou university Medical College | Recruiting | Shantou | Guangdong | 515041 | China |
|
| Yue Bei People's Hospital | Not yet recruiting | Shaoguan | Guangdong | 512026 | China |
|
| Shenzhen People's Hospital | Not yet recruiting | Shenzhen | Guangdong | 518020 | China |
|
| The Eighth Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting | Shenzhen | Guangdong | 518033 | China |
|
| Peking University Shenzhen Hospital | Not yet recruiting | Shenzhen | Guangdong | 518035 | China |
|
| Shenzhen Bao'an District People's Hospital | Not yet recruiting | Shenzhen | Guangdong | 518101 | China |
|
| Taishan people's Hospital | Not yet recruiting | Taishan | Guangdong | 529200 | China |
|
| Nanxiong people's Hospital | Not yet recruiting | Xiongzhou | Guangdong | 512400 | China |
|
| People's Hospital of Yangjiang City | Recruiting | Yangjiang | Guangdong | 529500 | China |
|
| The Second Affiliated Hospital of Guangdong Medical University | Not yet recruiting | Zhanjiang | Guangdong | China |
|
| Sihui people's Hospital | Recruiting | Zhaoqing | Guangdong | 526200 | China |
|
| Zhongshan People's Hospital | Not yet recruiting | Zhongshan | Guangdong | 528403 | China |
|
| The Fifth Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting | Zhuhai | Guangdong | 519000 | China |
|
| Zhuhai people's Hospital | Not yet recruiting | Zhuhai | Guangdong | 519000 | China |
|
| Guilin people's Hospital | Not yet recruiting | Guilin | Guangxi | 541002 | China |
|
| The Second Clinical College of Hainan Medical University | Not yet recruiting | Haikou | Hainan | 460106 | China |
|
| Hainan People's Hospital | Not yet recruiting | Haikou | Hainan | 570311 | China |
|
| Wuhan Asia Heart Hospital | Not yet recruiting | Wuhan | Hubei | 430022 | China |
|
| The Third Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 13787318063 | China |
|
| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410008 | China |
|
| GanZhou Municopal Hospital | Not yet recruiting | Ganzhou | Jiangxi | 341000 | China |
|
| Shangyou Hospital | Not yet recruiting | Ganzhou | Jiangxi | 341200 | China |
|
| Affiliated Hospital, Weifang Medical University | Not yet recruiting | Weifang | Shandong | 261031 | China |
|
| The first Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710061 | China |
|
| West China Hospital | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
|
| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
|
| Kashgar first people's Hospital | Not yet recruiting | Kashgar | Xinjiang | 844000 | China |
|
| The First Affilicated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830054 | China |
|
| Yan'an Hospital of Kunming City | Not yet recruiting | Kunming | Yunnan | 65005 | China |
|
| Shaoxing people's Hospital | Not yet recruiting | Shaoxing | Zhejiang | 312000 | China |
|
| The First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| 17692740 | Background | Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30. |
| 12021220 | Background | Beran G, Lang I, Schreiber W, Denk S, Stefenelli T, Syeda B, Maurer G, Glogar D, Siostrzonek P. Intracoronary thrombectomy with the X-sizer catheter system improves epicardial flow and accelerates ST-segment resolution in patients with acute coronary syndrome: a prospective, randomized, controlled study. Circulation. 2002 May 21;105(20):2355-60. doi: 10.1161/01.cir.0000016350.02669.1d. |
| 16022970 | Background | Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, Garramone B, Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo R, Crea F. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 2005 Jul 19;46(2):371-6. doi: 10.1016/j.jacc.2005.04.057. |
| 18539223 | Background | Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8. |
| 23991656 | Background | Frobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angeras O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Karegren A, Nilsson J, Robertson L, Sandhall L, Sjogren I, Ostlund O, Harnek J, James SK; TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013 Oct 24;369(17):1587-97. doi: 10.1056/NEJMoa1308789. Epub 2013 Aug 31. |
| 25853743 | Background | Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16. |
| 26498666 | Background | Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. No abstract available. |
| 27941066 | Background | Jolly SS, James S, Dzavik V, Cairns JA, Mahmoud KD, Zijlstra F, Yusuf S, Olivecrona GK, Renlund H, Gao P, Lagerqvist B, Alazzoni A, Kedev S, Stankovic G, Meeks B, Frobert O. Thrombus Aspiration in ST-Segment-Elevation Myocardial Infarction: An Individual Patient Meta-Analysis: Thrombectomy Trialists Collaboration. Circulation. 2017 Jan 10;135(2):143-152. doi: 10.1161/CIRCULATIONAHA.116.025371. Epub 2016 Dec 9. |
| 28886621 | Background | Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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