The Effect of Strict Dietary Intervention on Atherosclerotic Lesions in Patients Diagnosed With Coronary Artery Disease, Assessed by Coronary Computed Tomography Angiography (CCTA).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Percent Of Patheroma Volume (PAV)
研究概览
简要总结
The aim of the study is to determine, wheather strict dietary intervention with the use of the DASH diet atop of optimal medical treatment reduces previously diagnosed coronary atherosclerotic lesions assessed witch coronary computed tomography.
详细描述
A total of 180 patients with coronary atheroslerotc lesions confirmed in coronary computed tomography (CCT) will be analyzed in a 12-month observation time. Patients will be randomized to two groups in a 1:1 fashion. 1 - optimal medical treatment, 2 - strict dietary intervention with implementation of the DASH diet atop of optimal medical treatment. CCT scans will be performed at screening and at 12 months after randomization. Computed tomography imaging data describing atheroslerotic lesions will be assessed.
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
- 否
入选标准
- •coronary atheroslerotic lesions confirmed in the screening CCTA with reduction of the artery diameter less than 70% in 2 or more coronary artery segments
- •no indications for coronary angiography / revascularization (no documented significant ischemia of myocardium)
- •free and informed consent of the person concerned
- •willingness to follow the strict directions given by the investigators
排除标准
- •any valvular heart disease requiring cardiac surgery (or expected cardiac surgery intervention within 12 moths)
- •diagnosis of dilated / hypertrophic cardiomyopathy
- •diagnosis of DM t. 2
- •past CABG procedure
- •women in reproductive age
- •known genetic factors with a possible impact on the progres of coronary atherosclerotic lesions (e. i. congenital metabolic disorders, familial hyperlipidemias)
- •low quality of the CCTA data
研究组 & 干预措施
Dietary And Lifestyle Counseling
Patients receiving strict dietary counseling (implementation of the DASH diet) and lifestyle changes support atop of optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease.
干预措施: Dietary And Lifestyle Counseling (Behavioral)
Dietary And Lifestyle Counseling
Patients receiving strict dietary counseling (implementation of the DASH diet) and lifestyle changes support atop of optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease.
干预措施: Optimal Medical Treatment (Other)
Optimal Medical Treatment
Patients receiving optimal medical treatment as per 2013 ESC guidelines on the management of stable coronary artery disease.
干预措施: Optimal Medical Treatment (Other)
结局指标
主要结局
Percent Of Patheroma Volume (PAV)
时间窗: 12 months
Reduction of percent atheroma volume (PAV) measured between baseline and follow-up CT scans.
次要结局
- Pericardial Fat Distribution(12 months)
研究者
Cezary Kepka
Ass. Prof.
National Institute of Cardiology, Warsaw, Poland