CLINICAL TRIAL: CAROTID ATHEROSCLEROSIS (MRI) PROGRESSION STUDY (CAMPS)

临床试验：颈动脉粥样硬化 (MRI) 进展研究（CAMPS）

• 批准号: 7951371
• 负责人: JOHN R CROUSE
• 金额: $ 0.73万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951371
• 关键词: Ankle; Blood; Blood Pressure; Cardiac Catheterization Procedures; Cardiovascular system; Carotid Arteries; Carotid Artery Plaques; Carotid Atherosclerotic Disease; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Consent; Contrast Media; Coronary Angiography; Coronary Arteriosclerosis; Diabetes Mellitus; Disease; Electrocardiogram; Event; Female; Funding; Gadolinium; Grant; Health Sciences; Image; Institution; Interview; Magnetic Resonance Imaging; Measures; Medical History; Participant; Patients; Pharmaceutical Preparations; Procedures; Recruitment Activity; Registries; Research; Research Personnel; Resources; Scanning; Source; Testing; Ultrasonography; United States National Institutes of Health; follow-up; forest; male; pregnant

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study will test the hypothesis that carotid artery wall and plaque volume measured using magnetic resonance imaging (MRI) increases more rapidly in patients with coronary artery disease (CAD) than CAD-free controls over 2 years. Participants will be recruited from patients who previously participated in our non-invasive imaging studies. These patients were chosen to equally include male and female patients with known CAD and disease-free controls as defined at coronary angiography. We propose to recruit 200 participants from the previous studies. As required, we will recruit additional patients from the Wake Forest Health Sciences cardiac catheterization registry. At baseline, participants will be consented and interviewed about medical history and current medications, have blood drawn, vital signs measured, receive an ECG, and have ankle-brachial blood pressure ratio measured. Participants will next undergo an MRI scan of the carotid arteries. A subset of participants with (n=15) and without (n=15) diabetes and carotid plaques will be asked to have a gadolinium-enhanced MRI (MRI with contrast agent) as well. One hundred participants will also receive carotid artery B-mode ultrasound at baseline only. Participants will return in 2 years, and the procedures will be repeated. Participants will be contacted every 6 months between baseline and follow-up scans and for 3 years thereafter to ascertain cardiovascular events. Female subjects who might be pregnant will not be allowed to participate.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究将验证以下假设：在2年内，使用磁共振成像（MRI）测量的冠状动脉疾病（CAD）患者的颈动脉壁和斑块体积比无CAD对照组增加更快。参与者将从以前参加过我们的非侵入性成像研究的患者中招募。选择这些患者，以平等地包括已知患有CAD的男性和女性患者以及冠状动脉造影定义的无疾病对照。我们建议从以前的研究中招募200名参与者。根据需要，我们将从维克森林健康科学心导管注册中心招募更多患者。 在基线时，将对参与者进行知情同意，并就病史和当前药物进行访谈，抽血，测量生命体征，接受ECG，并测量踝臂血压比。参与者接下来将接受颈动脉的MRI扫描。患有（n=15）和不患有（n=15）糖尿病和颈动脉斑块的受试者亚组也将被要求进行钆增强MRI（造影剂MRI）。100名受试者还将仅在基线时接受颈动脉B型超声检查。参与者将在两年后返回，并重复这些程序。在基线和随访扫描之间每6个月联系一次受试者，此后3年，以确定心血管事件。 可能怀孕的女性受试者不得参加研究。