Reducing Risk Factors in Peripheral Arterial Disease

减少周围动脉疾病的危险因素

• 批准号: 7115192
• 负责人: Mary McGrae McDermott
• 金额: $ 74.11万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7115192
• 关键词: actigraphy; antihypercholesterolemic agent; atherosclerosis; behavior therapy; behavioral /social science research tag; body physical activity; cardiovascular disorder education; cardiovascular disorder risk; cholesterol; clinical research; clinical trials; counseling; diet therapy; education evaluation /planning; health behavior; health services research tag; human subject; human therapy evaluation; patient oriented research; peripheral blood vessel disorder; telemedicine; therapy compliance

DESCRIPTION (provided by applicant): In patients with peripheral arterial disease (PAD), this randomized, controlled clinical trial will test the ability of a telephone-counseling intervention to reduce Low Density Lipoprotein cholesterol (LDL-C) levels as compared to usual care and attention control conditions, respectively. Patients with PAD have a 3 to 4-fold higher risk of cardiovascular morbidity and mortality compared to patients without PAD. Risk of future cardiovascular events is comparable between patients with PAD and coronary artery disease (CAD). While improved atherosclerotic risk factor treatment has reduced cardiovascular morbidity and mortality in patients with CAD, such treatment in patients with PAD remains suboptimal. Intensity of cholesterol-lowering therapy, specifically, is significantly poorer in patients with PAD as compared to CAD. Pilot data collected for this study show that fully 69% of patients with PAD from our non-invasive vascular laboratory in Chicago did not have the recommended LDL-C level of < 100 mg/dl. Our published data show that many patients with PAD are unaware of their increased risk of cardiovascular events and under-appreciate the importance of risk factor treatment in PAD. These findings likely contribute to risk factor under-treatment in patients with PAD. Our data from a national survey also indicate that physicians believe atherosclerotic risk factor treatment is less important for patients with PAD than for patients with CAD. Clinical trials such as the 1 proposed are needed to demonstrate whether PAD risk factors can be reduced. If effective, this clinical trial will also encourage clinicians to adopt the proven intervention to lower cardiovascular risks in patients with PAD. This study involves 420 men and women with PAD who have LDL-C levels > 100 mg/dl at baseline identified from non-invasive vascular laboratories in Chicago, IL and Worcester, MA. For our primary specific aim, we hypothesize that subjects randomized to the intervention condition will achieve a reduction in LDL-C of at least 11.1 mg/dl greater than the reduction in LDL-C for subjects randomized to the attention control and usual care conditions, respectively, at 12-month follow-up. In our secondary aim, we will determine whether the telephone counseling intervention increases the proportion of PAD patients with LDLC < 100 mg/dl as compared to the attention control and usual care conditions, respectively, at 12-month follow-up. To identify the mediators of our intervention, in our exploratory aims we will determine whether patients in the intervention condition achieve greater increases (improvement) in specific behavioral and knowledge and attitude mediators that will be targeted by our intervention, as compared to patients in the attention control and usual care conditions, respectively.

描述（由申请人提供）：对于患有外周动脉疾病 (PAD) 的患者，这项随机对照临床试验将测试电话咨询干预与常规护理相比降低低密度脂蛋白胆固醇 (LDL-C) 水平的能力和注意力控制条件。与未患有 PAD 的患者相比，患有 PAD 的患者心血管发病率和死亡率的风险高出 3 至 4 倍。 PAD 患者和冠状动脉疾病 (CAD) 患者未来发生心血管事件的风险相当。虽然改进的动脉粥样硬化危险因素治疗降低了 CAD 患者的心血管发病率和死亡率，但这种治疗对于 PAD 患者来说仍然不够理想。具体而言，与 CAD 患者相比，PAD 患者的降胆固醇治疗强度明显较差。本研究收集的试点数据显示，我们芝加哥非侵入性血管实验室中 69% 的 PAD 患者的 LDL-C 水平未达到建议的 < 100 mg/dl。我们发表的数据显示，许多 PAD 患者没有意识到自己发生心血管事件的风险增加，并且低估了 PAD 危险因素治疗的重要性。这些发现可能导致 PAD 患者治疗不足的危险因素。我们的全国调查数据还表明，医生认为动脉粥样硬化危险因素治疗对于 PAD 患者的重要性不如 CAD 患者那么重要。需要进行诸如 1 之类的临床试验来证明是否可以减少 PAD 危险因素。如果有效，这项临床试验还将鼓励临床医生采用经过验证的干预措施来降低 PAD 患者的心血管风险。这项研究涉及 420 名患有 PAD 的男性和女性，他们的基线 LDL-C 水平 > 100 mg/dl，由伊利诺伊州芝加哥和马萨诸塞州伍斯特的非侵入性血管实验室确定。对于我们的主要具体目标，我们假设随机分配到干预条件的受试者将比随机分配到注意力控制和常规护理条件的受试者的 LDL-C 降低至少 11.1 mg/dl，分别在 12 个月的随访中。我们的次要目标是，在 12 个月的随访中，与注意力控制和常规护理条件相比，电话咨询干预是否会增加 LDLC < 100 mg/dl 的 PAD 患者比例。为了确定我们干预的中介因素，在我们的探索性目标中，我们将确定与处于注意力状态的患者相比，处于干预条件下的患者是否在我们干预的目标特定行为、知识和态度中介方面获得更大的增加（改善）分别是控制条件和常规护理条件。