急性心肌梗死后免疫反应的作用 (BATTLE-AMI)
2015年6月10日 更新者：Francisco Antonio Helfenstein Fonseca、Federal University of São Paulo
先天免疫和适应性免疫在急性心肌梗死后的作用 BATTLE-AMI 研究（B 型和 T 型淋巴细胞在急性心肌梗死中的评估）
淋巴细胞亚型在冠状动脉疾病发展中的迷人作用可能是理解和治疗急性心肌梗死的新战略目标。
细胞活力的决定因素是未知的，假设它们产生的因素不仅与微循环或能量消耗有关，而且与炎症和免疫反应有关。
此外，继发于心肌梗死的祖细胞的强烈动员会引发大量淋巴细胞增殖，从而在发育中的斑块中定植，从而导致复发性缺血结果。
该项目旨在评估参与缺血性心肌恢复和冠心病进展的免疫和代谢机制。
研究概览
地位
地位
未知
干预/治疗
干预/治疗
详细说明
具体而言，研究人员将研究先天免疫和适应性免疫，重点研究与急性心肌梗死患者的早期和晚期替代结果相关的淋巴细胞亚型、细胞培养和流式细胞术中的特征（B1、B2 和 T 淋巴细胞）和免疫反应（oxLDL 的 IgM 和 IgG 和 apoB 的特定表位）。 此外，该项目还将评估通过代谢组学研究确定的新生物标志物，以及相应的信号通路。 将评估自心肌梗死急性期至 6 个月的治疗药理学策略和肠道微生物群的变化。
在这项研究中，研究人员将比较四组联合治疗：氯吡格雷与瑞舒伐他汀；或氯吡格雷与辛伐他汀；或替格瑞洛与瑞舒伐他汀；或替格瑞洛与辛伐他汀。 研究者的假设是，与其他联合疗法相比，瑞舒伐他汀和替格瑞洛（协同多效作用）改善微循环可能会减少梗塞肿块面积，从而导致更好的左心室射血分数。
微生物群的监测和基因型将与在 MI 急性期以及 1 个月和 6 个月 FU 后获得的代谢组学和心脏 MRI 一起检查。
研究类型
研究类型
介入性
注册 (预期的)
注册
300
阶段
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
学习联系方式
- 姓名：Francisco A Fonseca, MD, PhD
- 电话号码：+55 11 992639082
- 邮箱：fahfonseca@terra.com.br
研究联系人备份
- 姓名：Maria C Izar, MD, PhD
- 电话号码：+55 11
- 邮箱：mcoizar@terra.com.br
学习地点
-
-
-
Sao Paulo、巴西、04040001
- 招聘中
- Hospital São Paulo - UNIFESP
-
接触：
- Francisco A H Fonseca, MD, PhD
- 电话号码：+5511992639082
- 邮箱：fahfonseca@terra.com.br
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
1.稳定的ST段抬高型心肌梗死（STEMI）患者，在前6小时或出现MI症状时接受溶栓治疗。
排除标准：
- 对研究药物方案的禁忌症或已知不耐受
- 患有肿瘤、肾功能不全（4 期或更高）等合并症的人
患者应在 AMI 的前 24 小时内随机分组，并在冠状动脉造影前至少 2 小时接受四种联合疗法中的一种治疗，然后在必要时进行经皮介入治疗。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
手臂数量
4
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
|
有源比较器：瑞舒伐他汀加氯吡格雷
瑞舒伐他汀 40 毫克和氯吡格雷 75 毫克
|
Crestor 40 mg 加 Brilinta 180 mg（初始剂量）和 90 mg bid，最多 6 个月
其他名称：
Zocor 40 毫克加 Plavix 600 毫克（初始剂量）和每天 75 毫克，最多 6 个月
其他名称：
Zocor 40 mg 加 Brilinta 180 mg（初始剂量）和 90 mg bid，最多 6 个月
其他名称：
|
|
有源比较器：瑞舒伐他汀加替格瑞洛
瑞舒伐他汀 40 mg 加替格瑞洛 90 mg bid
|
Zocor 40 毫克加 Plavix 600 毫克（初始剂量）和每天 75 毫克，最多 6 个月
其他名称：
Zocor 40 mg 加 Brilinta 180 mg（初始剂量）和 90 mg bid，最多 6 个月
其他名称：
Crestor 每天 40 毫克加上 Plavix 600 毫克（初始剂量）和每天 75 毫克，最多 6 个月
其他名称：
|
|
有源比较器：辛伐他汀加氯吡格雷
辛伐他汀 40 毫克加氯吡格雷 75 毫克
|
Crestor 40 mg 加 Brilinta 180 mg（初始剂量）和 90 mg bid，最多 6 个月
其他名称：
Zocor 40 mg 加 Brilinta 180 mg（初始剂量）和 90 mg bid，最多 6 个月
其他名称：
Crestor 每天 40 毫克加上 Plavix 600 毫克（初始剂量）和每天 75 毫克，最多 6 个月
其他名称：
|
|
有源比较器：辛伐他汀加替格瑞洛
辛伐他汀 40 毫克加替格瑞洛 90 毫克 bid
|
Crestor 40 mg 加 Brilinta 180 mg（初始剂量）和 90 mg bid，最多 6 个月
其他名称：
Zocor 40 毫克加 Plavix 600 毫克（初始剂量）和每天 75 毫克，最多 6 个月
其他名称：
Crestor 每天 40 毫克加上 Plavix 600 毫克（初始剂量）和每天 75 毫克，最多 6 个月
其他名称：
|
研究衡量的是什么？
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
STEMI 后四种联合治疗的左心室功能 (MRI) 比较
大体时间：1个月
|
治疗对左心室功能的影响将通过 MRI 测量
|
1个月
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
比较四种联合疗法对STEMI后左心室功能的影响
大体时间：3维
|
变量将通过 MRI 检查
|
3维
|
|
比较四种联合疗法对STEMI后左心室功能的影响
大体时间：6个月
|
变量将通过 MRI 检查
|
6个月
|
|
比较四种联合疗法对 STEMI 后梗死肿块面积的影响
大体时间：1个月
|
变量将通过 MRI 检查
|
1个月
|
|
比较四种联合疗法对 STEMI 后梗死肿块面积的影响
大体时间：6个月
|
变量将通过 MRI 检查
|
6个月
|
|
比较四种联合疗法对 STEMI 后左心室射血分数 < 40% 受试者百分比的影响
大体时间：1个月
|
变量将通过 MRI 检查
|
1个月
|
|
比较四种联合疗法对 STEMI 后左心室射血分数 < 40% 受试者百分比的影响
大体时间：6个月
|
变量将通过 MRI 检查
|
6个月
|
|
量化淋巴细胞 B1、B2、TCD4 和 TCD8 亚型的百分比和绝对数量及其与 STEMI 后左心室射血分数的相关性
大体时间：一维
|
通过流式细胞术定量淋巴细胞亚型，通过 MRI 定量左心室射血分数
|
一维
|
|
量化淋巴细胞 B1、B2、TCD4 和 TCD8 亚型的百分比和绝对数量及其与 STEMI 后左心室射血分数的相关性
大体时间：1个月
|
通过流式细胞术定量淋巴细胞亚型，通过 MRI 定量左心室射血分数
|
1个月
|
|
量化淋巴细胞 B1、B2、TCD4 和 TCD8 亚型的百分比和绝对数量及其与 STEMI 后左心室射血分数的相关性
大体时间：6个月
|
通过流式细胞术定量淋巴细胞亚型，通过 MRI 定量左心室射血分数
|
6个月
|
|
量化淋巴细胞 B1、B2、TCD4 和 TCD8 亚型的百分比和绝对数量及其与 STEMI 后梗死肿块面积的相关性
大体时间：一维
|
通过流式细胞术量化淋巴细胞亚型，通过 MRI 量化梗塞肿块面积
|
一维
|
|
量化淋巴细胞 B1、B2、TCD4 和 TCD8 亚型的百分比和绝对数量及其与 STEMI 后梗死肿块面积的相关性
大体时间：1个月
|
通过流式细胞术量化淋巴细胞亚型，通过 MRI 量化梗塞肿块面积
|
1个月
|
|
量化淋巴细胞 B1、B2、TCD4 和 TCD8 亚型的百分比和绝对数量及其与 STEMI 后梗死肿块面积的相关性
大体时间：6个月
|
通过流式细胞术量化淋巴细胞亚型，通过 MRI 量化梗塞肿块面积
|
6个月
|
|
量化淋巴细胞 B1、B2、TCD4 和 TCD8 亚型的百分比和绝对数量及其与 STEMI 后左心室射血分数 <40% 的相关性
大体时间：一维
|
通过流式细胞术定量淋巴细胞亚型，通过 MRI 定量左心室射血分数
|
一维
|
|
量化淋巴细胞 B1、B2、TCD4 和 TCD8 亚型的百分比和绝对数量及其与 STEMI 后左心室射血分数 <40% 的相关性
大体时间：1个月
|
通过流式细胞术定量淋巴细胞亚型，通过 MRI 定量左心室射血分数
|
1个月
|
|
量化淋巴细胞 B1、B2、TCD4 和 TCD8 亚型的百分比和绝对数量及其与 STEMI 后左心室射血分数 <40% 的相关性
大体时间：6个月
|
通过流式细胞术定量淋巴细胞亚型，通过 MRI 定量左心室射血分数
|
6个月
|
其他结果措施
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
STEMI 后肠道菌群与糖尿病状态的关系
大体时间：1-3天
|
肠道微生物群将根据 HbA1c 水平进行基因分型和糖尿病状态（非糖尿病、糖尿病前期或糖尿病）。
|
1-3天
|
|
STEMI 后肠道菌群与糖尿病状态的关系
大体时间：1个月
|
肠道微生物群将根据 HbA1c 水平进行基因分型和糖尿病状态（非糖尿病、糖尿病前期或糖尿病）。
|
1个月
|
|
肠道菌群与糖尿病状态的关系
大体时间：6个月
|
肠道微生物群将根据 HbA1c 水平进行基因分型和糖尿病状态（非糖尿病、糖尿病前期或糖尿病）。
|
6个月
|
|
肠道菌群与代谢组学的关系
大体时间：1-3天
|
肠道微生物群将通过 LC/MS-MS 进行基因分型和代谢组学
|
1-3天
|
|
肠道菌群与代谢组学的关系
大体时间：1个月
|
肠道微生物群将通过 LC/MS-MS 进行基因分型和代谢组学
|
1个月
|
|
肠道菌群与代谢组学的关系
大体时间：6个月
|
肠道微生物群将通过 LC/MS-MS 进行基因分型和代谢组学
|
6个月
|
|
四组联合治疗微粒与内皮祖细胞的比较
大体时间：一维
|
内皮细胞、血小板和单核细胞衍生的微粒以及内皮祖细胞将通过流式细胞仪进行定量
|
一维
|
|
四组联合治疗微粒与内皮祖细胞的比较
大体时间：1个月
|
内皮细胞、血小板和单核细胞衍生的微粒以及内皮祖细胞将通过流式细胞仪进行定量
|
1个月
|
|
四组联合治疗微粒与内皮祖细胞的比较
大体时间：6个月
|
内皮细胞、血小板和单核细胞衍生的微粒以及内皮祖细胞将通过流式细胞仪进行定量
|
6个月
|
|
冠心病严重程度与抗氧化低密度脂蛋白抗体和低密度脂蛋白载脂蛋白B肽D的相关性
大体时间：一维
|
将通过 ELISA 量化针对氧化的 LDL 以及针对 LDL 的肽 D 的抗体 IgG 和 IgM。
冠心病的严重程度将通过 Gensini 评分进行量化
|
一维
|
|
四组联合治疗对 TIMI 流量等级和脸红等级的比较
大体时间：一维
|
TIMI 流量等级和腮红等级将根据两名独立且盲态的认证侵入性心脏病专家在基线时获得的冠状动脉造影来确定
|
一维
|
|
MRI 获得的无复流图像与代谢组学之间的关系
大体时间：一维
|
代谢组学将通过 LC/MS-MS 确定，图像通过 MRI 确定
|
一维
|
|
MRI 获得的无复流图像与代谢组学之间的关系
大体时间：1个月
|
代谢组学将通过 LC/MS-MS 确定，图像通过 MRI 确定
|
1个月
|
|
MRI 获得的无复流图像与代谢组学之间的关系
大体时间：6个月
|
代谢组学将通过 LC/MS-MS 确定，图像通过 MRI 确定
|
6个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
合作者
调查人员
调查人员
- 首席研究员：Francisco A Fonseca, MD, PhD、Federal University of São Paulo
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Libby P, Ridker PM, Hansson GK; Leducq Transatlantic Network on Atherothrombosis. Inflammation in atherosclerosis: from pathophysiology to practice. J Am Coll Cardiol. 2009 Dec 1;54(23):2129-38. doi: 10.1016/j.jacc.2009.09.009.
- Quyyumi AA, Waller EK, Murrow J, Esteves F, Galt J, Oshinski J, Lerakis S, Sher S, Vaughan D, Perin E, Willerson J, Kereiakes D, Gersh BJ, Gregory D, Werner A, Moss T, Chan WS, Preti R, Pecora AL. CD34(+) cell infusion after ST elevation myocardial infarction is associated with improved perfusion and is dose dependent. Am Heart J. 2011 Jan;161(1):98-105. doi: 10.1016/j.ahj.2010.09.025.
- Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18.
- Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030.
- Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov 20;359(21):2195-207. doi: 10.1056/NEJMoa0807646. Epub 2008 Nov 9.
- Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.
- Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Macfadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Trial Study Group. Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet. 2009 Apr 4;373(9670):1175-82. doi: 10.1016/S0140-6736(09)60447-5. Epub 2009 Mar 28.
- Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. doi: 10.1056/NEJMoa040583. Epub 2004 Mar 8. Erratum In: N Engl J Med. 2006 Feb 16;354(7):778.
- Glynn RJ, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Ridker PM. A randomized trial of rosuvastatin in the prevention of venous thromboembolism. N Engl J Med. 2009 Apr 30;360(18):1851-61. doi: 10.1056/NEJMoa0900241. Epub 2009 Mar 29.
- Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
- Nicolau JC, Serrano CV Jr, Giraldez RR, Baracioli LM, Moreira HG, Lima F, Franken M, Kalil R, Ramires JA, Giugliano RP. In patients with acute myocardial infarction, the impact of hyperglycemia as a risk factor for mortality is not homogeneous across age-groups. Diabetes Care. 2012 Jan;35(1):150-2. doi: 10.2337/dc11-1170. Epub 2011 Oct 25.
- Fonseca FA, Izar MC, Fuster V, Gallo R, Padurean A, Fallon JT, Schachter EN, Chesebro JH, Badimon JJ. Chronic endothelial dysfunction after oversized coronary balloon angioplasty in pigs: a 12-week follow-up of coronary vasoreactivity in vivo and in vitro. Atherosclerosis. 2001 Jan;154(1):61-9. doi: 10.1016/s0021-9150(00)00458-5.
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- da Silva EF, Fonseca FA, Franca CN, Ferreira PR, Izar MC, Salomao R, Camargo LM, Tenore SB, Lewi DS. Imbalance between endothelial progenitors cells and microparticles in HIV-infected patients naive for antiretroviral therapy. AIDS. 2011 Aug 24;25(13):1595-601. doi: 10.1097/QAD.0b013e32834980f4.
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- Pomaro DR, Ihara SS, Pinto LE, Ueda I, Casarini DE, Ebihara F, Santos AO, Izar MC, Fonseca FA. High glucose levels abolish antiatherosclerotic benefits of ACE inhibition in alloxan-induced diabetes in rabbits. J Cardiovasc Pharmacol. 2005 Apr;45(4):295-300. doi: 10.1097/01.fjc.0000155384.64350.45.
- Relvas WG, Izar MC, Segreto HR, Giordani AJ, Ihara SS, Mariano M, Lopes JD, Popi AF, Helfenstein T, Pomaro D, Povoa RM, Carvalho AC, Fonseca FA. Resident peritoneal inflammatory cells are pivotal in the development of experimental atherosclerosis. J Atheroscler Thromb. 2010 Apr 30;17(4):378-85. doi: 10.5551/jat.3418. Epub 2010 Mar 9.
- Helfenstein T, Fonseca FA, Ihara SS, Bottos JM, Moreira FT, Pott H Jr, Farah ME, Martins MC, Izar MC. Impaired glucose tolerance plus hyperlipidaemia induced by diet promotes retina microaneurysms in New Zealand rabbits. Int J Exp Pathol. 2011 Feb;92(1):40-9. doi: 10.1111/j.1365-2613.2010.00753.x.
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- Ridker PM, MacFadyen JG, Fonseca FA, Genest J, Gotto AM, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Number needed to treat with rosuvastatin to prevent first cardiovascular events and death among men and women with low low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin (JUPITER). Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):616-23. doi: 10.1161/CIRCOUTCOMES.109.848473. Epub 2009 Sep 22.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
学习开始
2015年5月1日
初级完成 (预期的)
初级完成
2018年4月1日
研究完成 (预期的)
研究完成
2019年7月1日
研究注册日期
首次提交
首次提交
2015年3月10日
首先提交符合 QC 标准的
首先提交符合 QC 标准的
2015年4月27日
首次发布 (估计)
首次发布
2015年4月28日
研究记录更新
最后更新发布 (估计)
最后更新发布
2015年6月11日
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
2015年6月10日
最后验证
最后验证
2015年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
其他研究编号
- EPM/UNIFESP
- FAPESP (其他赠款/资助编号：2010/50120-4)
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