Novel Imaging to Predict Cardiovascular Events in Diabetes

预测糖尿病心血管事件的新型成像技术

• 批准号: 7664153
• 负责人: Michael E Farkouh
• 金额: $ 80.74万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-15 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7664153
• 关键词: Ancillary Study; Area; Arterial Fatty Streak; Atherosclerosis; Blinded; Blood specimen; Cardiovascular system; Cessation of life; Clinical; Coronary heart disease; Data; Death Certificates; Developed Countries; Developing Countries; Development; Diabetes Mellitus; Disease; Etiology; Evaluation; Event; Freedom; Future; Goals; Hemostatic Agents; Hospitals; Image; Imaging Techniques; Imaging technology; Inflammation; Intervention; Magnetic Resonance; Magnetic Resonance Imaging; Measurement; Measures; Medical; Metabolic; Myocardial Infarction; New York; Patients; Persons; Physical Examination; Pilot Projects; Positron-Emission Tomography; Process; Prospective Studies; Protocols documentation; Questionnaires; Recruitment Activity; Research Infrastructure; Resolution; Risk; Risk Factors; Screening procedure; Stroke; Telephone; Testing; Time; Visit; adjudication; base; cohort; cost; diabetic patient; expectation; experience; fluorodeoxyglucose positron emission tomography; follow-up; heart disease risk; high risk; improved; inflammatory marker; medical schools; metropolitan; mortality; novel; patient population; pill; prospective; public health relevance; tool

DESCRIPTION (provided by applicant): Novel non-invasive imaging tests have been developed to characterize atherosclerotic plaque burden and metabolic activity (inflammation). However, the value of these atherosclerosis imaging technologies for predicting coronary heart disease (CHD) and stroke events has not been evaluated in prospective studies. Proposed is a study to conduct noninvasive imaging and longitudinal follow-up in a high risk cohort of patients with diabetes by utilizing the recruitment network, events follow-up protocol and adjudication committee assembled by the NHLBI-sponsored FREEDOM Trial (Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease - HL071988). Specific aims of our study are (1) to determine the association of atherosclerotic plaque burden and the risk of CHD and stroke events and all cause-mortality; (2) to determine the association between traditional CHD risk factors and atherosclerotic plaque burden; and (3) to determine the association between plaque burden and plaque inflammation. In order to accomplish these aims, we will recruit 380 diabetic patients with multi-vessel coronary disease from eleven greater New York metropolitan area hospitals. Patients will complete a baseline study visit at Mount Sinai School of Medicine (MSSM) to assess plaque burden and plaque inflammation by magnetic resonance (MR) (contrast and non contrast) and fluorodeoxyglucose (FDG)-positron emission tomography (PET) imaging. Additionally, questionnaires will be administered, a physical examination conducted and blood specimens collected to measure hemostatic and inflammatory markers. Patients will be actively followed for 36 months through annual in-person study visits and bi-annual telephone follow-up. When events (mortality, non-fatal MI and non-fatal stroke) are identified, hospital charts and death certificates will be reviewed by an adjudications committee, blinded to the baseline measurement values. Changes in plaque burden and inflammation will be assessed through MR and FDG-PET imaging, respectively, at the 36 month follow-up visit again at MSSM. The proposed study will provide the unique opportunity to assess atherosclerotic plaque burden as a predictor for clinical events in a high risk patient cohort. Data from this study will not only advance our understanding of the aggressive atherosclerotic process associated with diabetes but will also provide us with a strategy to combine novel noninvasive approaches to better follow the effects of medical and revascularization therapy in the diabetic patient. It is our expectation that data from the proposed study will be utilized to evaluate and improve existing treatment and help guide the development of effective new therapies aimed at reducing CHD and stroke events and improving survival in high risk diabetic patients. PUBLIC HEALTH RELEVANCE: The FREEDOM Imaging study aims to determine the prospective association of atherosclerotic plaque burden, assessed through non-invasive MRI, and clinical events in high risk patients with diabetes mellitus. Data from the FREEDOM Imaging study will not only advance our understanding of the aggressive atherosclerotic process associated with diabetes, but will also provide us with a strategy to combine novel tools to better follow the effects of medical and revascularization therapy in the diabetic patient. It is our expectation that our data will be utilized to evaluate and improve existent treatment and develop effective new therapies to decrease the burden of atherosclerotic disease in diabetes.

描述（由申请人提供）：已经开发出新的非侵入性成像测试来表征动脉粥样硬化的斑块负担和代谢活性（炎症）。但是，这些动脉粥样硬化成像技术对于预测冠心病（CHD）和中风事件的价值尚未在前瞻性研究中评估。 Proposed is a study to conduct noninvasive imaging and longitudinal follow-up in a high risk cohort of patients with diabetes by utilizing the recruitment network, events follow-up protocol and adjudication committee assembled by the NHLBI-sponsored FREEDOM Trial (Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease - HL071988).我们研究的具体目的是（1）确定动脉粥样硬化斑块负担的关联以及冠心病和中风事件的风险以及所有原因； （2）确定传统的CHD危险因素与动脉粥样硬化斑块负担之间的关联； （3）确定斑块负担与斑块炎症之间的关联。为了实现这些目标，我们将招募380名来自纽约大都会地区医院的多血管冠状动脉疾病的糖尿病患者。患者将在西奈山医学院（MSSM）完成一项基线研究访问，以评估磁共振（MR）（对比度和非对比度）以及氟脱氧葡萄糖（FDG）-Positron-positron-Positron发射断层扫描（PET）成像。此外，将进行调查表，进行体格检查，并收集血液标本以测量止血和炎症标志物。通过年度面对面研究就诊和两年一次的电话随访，将积极进行36个月的时间。当确定事件（死亡率，非致命的MI和非致命中风）时，将由裁决委员会审查医院图表和死亡证书，对基线测量值蒙蔽。在MSSM再次进行36个月的随访访问中，将分别通过MR和FDG-PET成像评估斑块负担和炎症的变化。拟议的研究将提供独特的机会，以评估动脉粥样硬化斑块负担，以作为高风险患者队列中临床事件的预测指标。这项研究的数据不仅将提高我们对与糖尿病相关的积极动脉粥样硬化过程的理解，而且还将为我们提供一种结合新型无创方法的策略，以更好地遵循糖尿病患者的医学和血运重建疗法的影响。我们期望将拟议研究的数据用于评估和改善现有治疗方法，并有助于指导开发有效的新疗法，旨在减少CHD和中风事件并改善高风险糖尿病患者的生存率。公共卫生相关性：自由成像研究旨在确定通过非侵入性MRI评估动脉粥样硬化斑块负担的前瞻性关联，以及高风险糖尿病患者的临床事件。来自自由成像研究的数据不仅会提高我们对与糖尿病相关的侵略性动脉粥样硬化过程的理解，而且还将为我们提供一种结合新颖工具的策略，以更好地遵循糖尿病患者的医学和血运重建疗法的影响。我们期望将我们的数据用于评估和改善现有治疗方法，并开发有效的新疗法，以减轻糖尿病中动脉粥样硬化疾病的负担。