Reducing Risk Factors in Peripheral Arterial Disease

减少周围动脉疾病的危险因素

• 批准号: 6976918
• 负责人: Mary McGrae McDermott
• 金额: $ 76.87万
• 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/6976918
• 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）：在外周科动脉疾病（PAD）的患者中，这项随机，对照临床试验将测试与常规护理和注意力控制条件相比，分别与通常的护理和注意力控制条件相比，电话会议干预措施分别降低低密度脂蛋白胆固醇（LDL-C）水平的能力。与没有PAD的患者相比，PAD患者的心血管发病率和死亡率高3至4倍。 PAD和冠状动脉疾病（CAD）患者的未来心血管事件的风险是可比的。虽然改善的动脉粥样硬化危险因素治疗可降低CAD患者的心血管发病率和死亡率，但PAD患者的这种治疗仍然是最佳的。与CAD相比，PAD患者的降低胆固醇疗法的强度明显较差。这项研究收集的试验数据表明，来自芝加哥非侵入性血管实验室的PAD患者中有69％的患者的建议LDL-C水平<100 mg/dl。我们已发表的数据表明，许多患有PAD的患者并不意识到他们发生心血管事件的风险增加，并且不足以使危险因素治疗在PAD中的重要性。这些发现可能导致PAD患者的风险因素不足。我们来自全国调查的数据还表明，医生认为动脉粥样硬化危险因素治疗对PAD患者的重要性不如CAD患者重要。需要进行临床试验，例如提出的1个试验，以证明是否可以降低PAD危险因素。如果有效，这项临床试验还将鼓励临床医生采取可靠的干预措施，以降低PAD患者的心血管风险。这项研究涉及420名男性和女性，其在基线的LDL-C水平> 100 mg/dl的男性和女性从马萨诸塞州芝加哥和马萨诸塞州芝加哥的非侵入性血管实验室中鉴定出来。对于我们的主要特定目的，我们假设随机分配干预条件的受试者将使LDL-C的降低至少11.1 mg/dL大于LDL-C的降低，分别在12个月的随访中，分别将其与注意力控制和常规护理条件的受试者的降低相比。在我们的次要目标中，我们将确定电话咨询干预措施是否分别在12个月的随访中分别增加了LDLC <100 mg/dl的PAD患者的比例。为了确定干预措施的调解人，在我们的探索目的中，我们将确定与注意力控制和常规护理条件中的患者相比，在干预条件下的患者在特定的行为和知识和态度介体方面是否会增加（改善）。