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临床试验/NCT00269425
NCT00269425已完成3 期

The Heart Institute of Spokane Diet Intervention and Evaluation Trial (THIS DIET)

Providence Health & Services2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2000年10月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
202
试验地点
2
主要终点
Fatal/non-fatal myocardial infarction

研究概览

简要总结

The purpose of this study is to determine whether a Mediterranean style diet, enriched in monounsaturated and omega-3 fats, is superior to the American Heart Association Step 2 diet, a traditional low fat diet, for improving rates of survival and cardiovascular complications in persons who have had a first myocardial infarction (heart attack).

详细描述

Cardiovascular diseases (heart attack, stroke, and other vascular diseases) are major causes of mortality in developed countries. Although medicines and revascularization procedures prolong lives, rates of death and disability remain high. Lifestyle factors greatly contribute to risk. Yet, scientific data regarding the role of lifestyle change in prevention and treatment are limited. In the nutrition area, limitations include observational or uncontrolled study design, and focus on surrogate markers rather than on clinical outcomes.

Excess dietary fat has long been associated with cardiovascular diseases. Increased risk is related both to types of fat and calories from fat. Saturated fat, cholesterol, and trans-fatty acids have all been associated with adverse outcomes. Because fat is calorie-laden, high fat diets are commonly associated with weight gain and obesity. Low-fat diets have traditionally been recommended to control lipids and weight. However, these diets are high in carbohydrate and may actually be associated with weight gain if calories are not limited. Such diets have also been associated with worsening of hyperinsulinemia and insulin resistance and an adverse lipid pattern (low HDL cholesterol and high triglyceride levels). In contrast, increased intake of monounsaturated and omega-3 fats is associated with favorable effects on cardiovascular risk factors and markers including: endothelial function, lipids, and levels of insulin and glucose. Results have been consistent across various groups of high-risk patients, including those with hypercholesterolemia, diabetes, and hypertension. Most importantly, a Mediterranean style diet enriched in monounsaturated and omega-3 fats reduced death and cardiovascular complications after myocardial infarction (MI) in the Lyon Heart study.

The American Heart Association (AHA) Step 2 is a low-fat diet traditionally recommended for people with cardiovascular disease. The Mediterranean and AHA Step 2 diets differ primarily in the amount of monounsaturated and omega-3 fats, both of which are higher in the Mediterranean diet. Both diets are low in saturated fat (less than 7%) and cholesterol (less than 200 mg/d). Although the Lyon Heart Study compared a Mediterranean diet to a "prudent Western diet," a low fat diet similar to the AHA diet, the latter group did not achieve recommended intake levels of saturated fat or cholesterol. Furthermore, there was no longitudinal nutritional intervention in the low fat diet group. Therefore, the effect of nutritional intervention per se was not addressed.

Comparison(s): In survivors of a first MI, two longitudinal nutritional interventions, a Mediterranean style diet and an AHA Step 2 diet, will be compared. Both intervention groups will be compared to an untreated control group from our clinical database.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First myocardial infarction

排除标准

  • Prior myocardial infarction
  • Uncontrolled or secondary hypertension
  • New York Heart Association heart failure stage III or IV
  • Ventricular arrythmias requiring medical or defibrillatory intervention
  • Other diseases that may make study completion difficult or unlikely

结局指标

主要结局

Fatal/non-fatal myocardial infarction

时间窗: 3,6,12,18,24,36,48,60,72 months

The primary outcome was a composite of end points including all-cause and cardiac deaths, MI, hospital admissions for heart failure, unstable angina, or stroke.

Cardiovascular death

时间窗: 3,6,12,18,24,36,48,60,72 months

Non-cardiovascular death

时间窗: 3,6,12,18,24,36,48,60,72 months

Stroke/TIA

时间窗: 3,6,12,18,24,36,48,60,72 months

Admission for congestive heart failure or unstable angina

时间窗: 3,6,12,18,24,36,48,60,72 months

次要结局

  • Cardiovascular revascularization(3,6,12,18,24,36,48,60,72 months)
  • Peripheral revascularization or amputation(3,6,12,18,24,36,48,60,72 months)
  • Doubling of serum creatinine,dialysis,or kidney transplant(3,6,12,18,24,36,48,60,72 months)
  • New hypertension(3,6,12,18,24,36,48,60,72 months)
  • New diabetes(3,6,12,18,24,36,48,60,72 months)
  • Risk factors (traditional and novel)(3,6,12,18,24,36,48,60,72 months)

研究者

申办方类型
Other

研究点 (2)

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The Heart Institute of Spokane Diet Study | 临床试验