高级心脏成像预测脑 MRI 栓塞性中风:一项初步研究
研究概览
详细说明
研究人员提出了一项横断面队列研究,其中没有房颤病史且患有充血性心力衰竭、高血压、年龄 ≥ 75 岁、糖尿病、中风或短暂性脑缺血发作 (TIA)、血管疾病、年龄在 65 至 74 岁之间的个体年,性别分类评分(CHA2DS2VASC)≥3,II 型糖尿病,充血性心力衰竭或中风/TIA 病史。 通过采访参与者和查看电子病历,将获得有关人口统计、个人健康习惯、药物和病史的数据。 所有参与者都将接受心脏磁共振成像 (CMR) 以评估 LA 和 LAA 病理学标志物。 将研究的 LA 和 LAA 病理学标志物包括:LA 纤维化水平、LA 功能参数、LA 形状特征和 LAA 特征(包括形态、孔口面积和流速)。 此外,所有参与者都将在同一次就诊时接受脑部磁共振成像 (MRI),以评估是否存在栓塞样脑梗死,无论之前是否有中风相关症状。
研究人员将分析每个心脏成像特征与脑部 MRI 上出现栓塞性中风的患病率之间的关联,以确定具有较高 LA 和 LAA 重构特征的患者是否更有可能在 MRI 上出现栓塞性脑梗塞。 具有最强统计关联的 LA 和 LAA 病理成像特征将用于开发能够识别栓塞性中风风险最高的患者的成像预测评分。
所有大脑和心脏成像数据都将由经验丰富的操作员在杜兰医疗中心设施进行评估。 分析 CMR 的操作员将不知道大脑 MRI 结果,评估大脑 MRI 的操作员将不知道 CMR 结果。 该研究将包括在杜兰医疗中心和诊所进行的单中心研究,研究人员来自不同的医学专业,并配备适当的设施和设备来准确、安全地开展该项目。 研究人员希望在 18 个月的时间内从心脏病学和神经学诊所招募 120 名受试者来完成这项研究。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Louisiana
-
New Orleans、Louisiana、美国、70112
- Tulane University Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 男性或女性患者
- 18岁及以上
- 无房颤病史
- CHA2DS2VASC 评分≥3
- II型糖尿病病史
- 充血性心力衰竭病史或短暂性脑缺血发作 (TIA)/中风病史,无其他定义的中风病因,如大血管或小血管疾病
排除标准:
- 房颤病史
- 在过去 30 天内发生过有临床症状的急性卒中患者
- 任何与健康相关的钆/MRI 禁忌症(包括以前对钆、心脏起搏器、除颤器、其他 MRI 禁忌设备/植入物的过敏反应)
- 不能使用钆的慢性肾脏病 (CKD) 患者的估计肾小球滤过率 (eGFR) 截止值等于 eGFR <30 ml/min
- 重量 > 300 磅(因为 CMR 图像质量因体重指数增加而降低)
- 目前怀孕或哺乳
- 认知障碍使患者无法给予知情同意
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:病人手臂
所有患者都将接受 CMR,以在 1.5 或 3 特斯拉临床 MR 扫描仪上评估 LA 和 LAA 高风险特征。 将注射钆。 钆是一种造影产品,有助于确定洛杉矶纤维化的区域。 无对比的高分辨率脑 MRI 将包括以下序列,以便最准确地评估栓塞病变:3D T1 MPRAGE、3D FLAIR、DWI、ADC 和 SWI |
将使用 CMR 在 1.5 或 3 特斯拉临床 MR 扫描仪上评估 LA 和 LAA 高风险特征。 将进行钆注射。 钆是一种对比产品,有助于确定 LA 中的纤维化区域。 无对比的高分辨率脑 MRI 将包括以下序列,以最准确地评估栓塞病变:3D T1 MPRAGE、3D FLAIR、DWI、ADC 和 SWI |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
存在隐性栓塞性脑梗塞
大体时间:第一天
|
隐性栓塞性脑梗塞定义为在皮质、皮质旁区域和小脑中存在无症状的非腔隙性栓塞性梗塞(急性或慢性,根据 MRI 表现)。
他们将使用大脑 MRI 进行识别。
|
第一天
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
隐蔽性违法行为的计数
大体时间:第一天
|
隐性腔隙性梗塞是皮质下脑区最大直径小于 15mm 的无症状梗塞。
将使用大脑 MRI 图像根据大小和位置识别它们。
|
第一天
|
|
腔隙性症状性梗塞计数
大体时间:第一天
|
症状性腔隙性梗塞是皮质下脑区最大直径<15mm 的症状性梗塞。
将使用大脑 MRI 图像根据大小和位置识别它们。
|
第一天
|
|
栓塞症状性梗塞计数
大体时间:第一天
|
症状性非腔隙性栓塞梗塞是皮质中任何大小的症状性梗塞或皮质下病变中最大直径 >15 毫米的梗塞。
将使用大脑 MRI 图像根据大小和位置识别它们。
|
第一天
|
合作者和调查者
调查人员
- 首席研究员:Nassir Marrouche, MD、Tulane School of Medicine
出版物和有用的链接
一般刊物
- Gupta A, Giambrone AE, Gialdini G, Finn C, Delgado D, Gutierrez J, Wright C, Beiser AS, Seshadri S, Pandya A, Kamel H. Silent Brain Infarction and Risk of Future Stroke: A Systematic Review and Meta-Analysis. Stroke. 2016 Mar;47(3):719-25. doi: 10.1161/STROKEAHA.115.011889.
- Gorelick PB, Scuteri A, Black SE, Decarli C, Greenberg SM, Iadecola C, Launer LJ, Laurent S, Lopez OL, Nyenhuis D, Petersen RC, Schneider JA, Tzourio C, Arnett DK, Bennett DA, Chui HC, Higashida RT, Lindquist R, Nilsson PM, Roman GC, Sellke FW, Seshadri S; American Heart Association Stroke Council, Council on Epidemiology and Prevention, Council on Cardiovascular Nursing, Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia. Vascular contributions to cognitive impairment and dementia: a statement for healthcare professionals from the american heart association/american stroke association. Stroke. 2011 Sep;42(9):2672-713. doi: 10.1161/STR.0b013e3182299496. Epub 2011 Jul 21.
- Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ, Breteler MM. Silent brain infarcts and the risk of dementia and cognitive decline. N Engl J Med. 2003 Mar 27;348(13):1215-22. doi: 10.1056/NEJMoa022066.
- King JB, Azadani PN, Suksaranjit P, Bress AP, Witt DM, Han FT, Chelu MG, Silver MA, Biskupiak J, Wilson BD, Morris AK, Kholmovski EG, Marrouche N. Left Atrial Fibrosis and Risk of Cerebrovascular and Cardiovascular Events in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Sep 12;70(11):1311-1321. doi: 10.1016/j.jacc.2017.07.758.
- Siebermair J, Suksaranjit P, McGann CJ, Peterson KA, Kheirkhahan M, Baher AA, Damal K, Wakili R, Marrouche NF, Wilson BD. Atrial fibrosis in non-atrial fibrillation individuals and prediction of atrial fibrillation by use of late gadolinium enhancement magnetic resonance imaging. J Cardiovasc Electrophysiol. 2019 Apr;30(4):550-556. doi: 10.1111/jce.13846. Epub 2019 Jan 24.
- Al-Saady NM, Obel OA, Camm AJ. Left atrial appendage: structure, function, and role in thromboembolism. Heart. 1999 Nov;82(5):547-54. doi: 10.1136/hrt.82.5.547.
- Gaita F, Corsinovi L, Anselmino M, Raimondo C, Pianelli M, Toso E, Bergamasco L, Boffano C, Valentini MC, Cesarani F, Scaglione M. Prevalence of silent cerebral ischemia in paroxysmal and persistent atrial fibrillation and correlation with cognitive function. J Am Coll Cardiol. 2013 Nov 19;62(21):1990-1997. doi: 10.1016/j.jacc.2013.05.074. Epub 2013 Jul 10.
- Saver JL. CLINICAL PRACTICE. Cryptogenic Stroke. N Engl J Med. 2016 May 26;374(21):2065-74. doi: 10.1056/NEJMcp1503946. No abstract available.
- Fanning JP, Wong AA, Fraser JF. The epidemiology of silent brain infarction: a systematic review of population-based cohorts. BMC Med. 2014 Jul 9;12:119. doi: 10.1186/s12916-014-0119-0.
- Fanning JP, Wesley AJ, Wong AA, Fraser JF. Emerging spectra of silent brain infarction. Stroke. 2014 Nov;45(11):3461-71. doi: 10.1161/STROKEAHA.114.005919. Epub 2014 Oct 7. No abstract available.
- Brambatti M, Connolly SJ, Gold MR, Morillo CA, Capucci A, Muto C, Lau CP, Van Gelder IC, Hohnloser SH, Carlson M, Fain E, Nakamya J, Mairesse GH, Halytska M, Deng WQ, Israel CW, Healey JS; ASSERT Investigators. Temporal relationship between subclinical atrial fibrillation and embolic events. Circulation. 2014 May 27;129(21):2094-9. doi: 10.1161/CIRCULATIONAHA.113.007825. Epub 2014 Mar 14.
- Daoud EG, Glotzer TV, Wyse DG, Ezekowitz MD, Hilker C, Koehler J, Ziegler PD; TRENDS Investigators. Temporal relationship of atrial tachyarrhythmias, cerebrovascular events, and systemic emboli based on stored device data: a subgroup analysis of TRENDS. Heart Rhythm. 2011 Sep;8(9):1416-23. doi: 10.1016/j.hrthm.2011.04.022. Epub 2011 Apr 23.
- Friberg L, Rosenqvist M, Lip GY. Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur Heart J. 2012 Jun;33(12):1500-10. doi: 10.1093/eurheartj/ehr488. Epub 2012 Jan 13.
- Fang MC, Go AS, Chang Y, Borowsky L, Pomernacki NK, Singer DE; ATRIA Study Group. Comparison of risk stratification schemes to predict thromboembolism in people with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2008 Feb 26;51(8):810-5. doi: 10.1016/j.jacc.2007.09.065.
- Keogh C, Wallace E, Dillon C, Dimitrov BD, Fahey T. Validation of the CHADS2 clinical prediction rule to predict ischaemic stroke. A systematic review and meta-analysis. Thromb Haemost. 2011 Sep;106(3):528-38. doi: 10.1160/TH11-02-0061. Epub 2011 Jul 28.
- Zghaib T, Nazarian S. New Insights Into the Use of Cardiac Magnetic Resonance Imaging to Guide Decision Making in Atrial Fibrillation Management. Can J Cardiol. 2018 Nov;34(11):1461-1470. doi: 10.1016/j.cjca.2018.07.007. Epub 2018 Jul 12.
- Bisbal F, Baranchuk A, Braunwald E, Bayes de Luna A, Bayes-Genis A. Atrial Failure as a Clinical Entity: JACC Review Topic of the Week. J Am Coll Cardiol. 2020 Jan 21;75(2):222-232. doi: 10.1016/j.jacc.2019.11.013.
- Daccarett M, Badger TJ, Akoum N, Burgon NS, Mahnkopf C, Vergara G, Kholmovski E, McGann CJ, Parker D, Brachmann J, Macleod RS, Marrouche NF. Association of left atrial fibrosis detected by delayed-enhancement magnetic resonance imaging and the risk of stroke in patients with atrial fibrillation. J Am Coll Cardiol. 2011 Feb 15;57(7):831-8. doi: 10.1016/j.jacc.2010.09.049.
- Inoue YY, Alissa A, Khurram IM, Fukumoto K, Habibi M, Venkatesh BA, Zimmerman SL, Nazarian S, Berger RD, Calkins H, Lima JA, Ashikaga H. Quantitative tissue-tracking cardiac magnetic resonance (CMR) of left atrial deformation and the risk of stroke in patients with atrial fibrillation. J Am Heart Assoc. 2015 Apr 27;4(4):e001844. doi: 10.1161/JAHA.115.001844.
- Kamel H, Okin PM, Merkler AE, Navi BB, Campion TR, Devereux RB, Diaz I, Weinsaft JW, Kim J. Relationship between left atrial volume and ischemic stroke subtype. Ann Clin Transl Neurol. 2019 Aug;6(8):1480-1486. doi: 10.1002/acn3.50841. Epub 2019 Jul 26.
- Jeong WK, Choi JH, Son JP, Lee S, Lee MJ, Choe YH, Bang OY. Volume and morphology of left atrial appendage as determinants of stroke subtype in patients with atrial fibrillation. Heart Rhythm. 2016 Apr;13(4):820-7. doi: 10.1016/j.hrthm.2015.12.026. Epub 2015 Dec 18.
- Yaghi S, Song C, Gray WA, Furie KL, Elkind MS, Kamel H. Left Atrial Appendage Function and Stroke Risk. Stroke. 2015 Dec;46(12):3554-9. doi: 10.1161/STROKEAHA.115.011273. Epub 2015 Oct 27. No abstract available.
- Bokura H, Kobayashi S, Yamaguchi S, Iijima K, Nagai A, Toyoda G, Oguro H, Takahashi K. Silent brain infarction and subcortical white matter lesions increase the risk of stroke and mortality: a prospective cohort study. J Stroke Cerebrovasc Dis. 2006 Mar-Apr;15(2):57-63. doi: 10.1016/j.jstrokecerebrovasdis.2005.11.001.
- Debette S, Beiser A, DeCarli C, Au R, Himali JJ, Kelly-Hayes M, Romero JR, Kase CS, Wolf PA, Seshadri S. Association of MRI markers of vascular brain injury with incident stroke, mild cognitive impairment, dementia, and mortality: the Framingham Offspring Study. Stroke. 2010 Apr;41(4):600-6. doi: 10.1161/STROKEAHA.109.570044. Epub 2010 Feb 18.
- Cogswell RJ, Norby FL, Gottesman RF, Chen LY, Solomon S, Shah A, Alonso A. High prevalence of subclinical cerebral infarction in patients with heart failure with preserved ejection fraction. Eur J Heart Fail. 2017 Oct;19(10):1303-1309. doi: 10.1002/ejhf.812. Epub 2017 Jul 24.
- Chubb H, Karim R, Roujol S, Nunez-Garcia M, Williams SE, Whitaker J, Harrison J, Butakoff C, Camara O, Chiribiri A, Schaeffter T, Wright M, O'Neill M, Razavi R. The reproducibility of late gadolinium enhancement cardiovascular magnetic resonance imaging of post-ablation atrial scar: a cross-over study. J Cardiovasc Magn Reson. 2018 Mar 19;20(1):21. doi: 10.1186/s12968-018-0438-y.
- Margulescu AD, Nunez-Garcia M, Alarcon F, Benito EM, Enomoto N, Cozzari J, Chipa F, Fernandez H, Borras R, Guasch E, Butakoff C, Tolosana JM, Arbelo E, Camara O, Mont L. Reproducibility and accuracy of late gadolinium enhancement cardiac magnetic resonance measurements for the detection of left atrial fibrosis in patients undergoing atrial fibrillation ablation procedures. Europace. 2019 May 1;21(5):724-731. doi: 10.1093/europace/euy314.
- Bisbal F, Gomez-Pulido F, Cabanas-Grandio P, Akoum N, Calvo M, Andreu D, Prat-Gonzalez S, Perea RJ, Villuendas R, Berruezo A, Sitges M, Bayes-Genis A, Brugada J, Marrouche NF, Mont L. Left Atrial Geometry Improves Risk Prediction of Thromboembolic Events in Patients With Atrial Fibrillation. J Cardiovasc Electrophysiol. 2016 Jul;27(7):804-10. doi: 10.1111/jce.12978. Epub 2016 May 13.
- Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
- Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3.
- Habibi M, Zareian M, Ambale Venkatesh B, Samiei S, Imai M, Wu C, Launer LJ, Shea S, Gottesman RF, Heckbert SR, Bluemke DA, Lima JAC. Left Atrial Mechanical Function and Incident Ischemic Cerebrovascular Events Independent of AF: Insights From the MESA Study. JACC Cardiovasc Imaging. 2019 Dec;12(12):2417-2427. doi: 10.1016/j.jcmg.2019.02.021. Epub 2019 Apr 17.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.