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临床试验/NCT06031974
NCT06031974Enrolling By Invitation不适用

Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up

National Institute of Cardiology, Warsaw, Poland1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2023年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
92
试验地点
1
主要终点
Percent Atheroma Volume (PAV) (Change)

研究概览

简要总结

A long-term evaluation of the impact of intensive diet and lifestyle intervention on coronary plaque dynamics in patients with coronary atherosclerosis diagnosed in computed tomography angiography (CCTA).

92 patients who completed the Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography study (DISCO-CT, NCT02571803) will be followed-up.

详细描述

All patients who completed the Dietary Intervention to Stop COronary Atherosclerosis in Computed Tomography received dietary and lifestyle recommendations and were referred to outpatient specialist care at their place of residence.

As part of this study, patients will be invited for a follow-up visit consisting of a cardiological and dietician consultation and additional tests, including CCTA, to assess the long-term impact of the intervention on the progression of atherosclerotic plaques, including high-risk plaque component.

Additionally, the occurrence of cardiovascular events, change in laboratory parameters and change in body weight composition will be analyzed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percent Atheroma Volume (PAV) (Change)

时间窗: 60 months

Quantitative assessment of the coronary plaque dynamics will be analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study (expressed in percent) PAV = \[(EEM-LA)/EEM\]\*100% EEM - external elastic membrane area LA - lumen area

Total Atheroma Volume (Change)

时间窗: 60 months

Quantitative assessment of the coronary plaque dynamics will be analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study (expressed in mm3)

次要结局

  • Calcified Plaque Volume (Change)(60 months)
  • Rate of major cardiovascular events(60 months)
  • Fibrous Plaque Volume (Change)(60 months)
  • Fibrofatty Plaque Volume (Change)(60 months)
  • Necrotic Core (Low Density) Plaque Volume (Change)(60 months)
  • Non-Calcified Plaque Volume (Change)(60 months)

研究者

发起方
National Institute of Cardiology, Warsaw, Poland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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