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临床试验/NCT02354196
NCT02354196撤回不适用

Big PICTURE 2: Physicians International CT Utilization Registry 2

MDDX LLC2 个研究点 分布在 2 个国家开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
MDDX LLC
试验地点
2
主要终点
Plaque characteristics

研究概览

简要总结

To determine the total plaque burden, plaque severity and composition of patients undergoing Cardiac CT who do not have any previous history of CVD. There are two cohorts:

  1. A retrospective follow-up for MACE endpoints of patients who underwent a CCTA >1 year ago as part of the Big PICTURE Trial, who meet the inclusion criteria of Big PICTURE 2.
  2. A prospective observational registry of patients referred to undergo CCTA with a 1 and 2 year follow-up.

详细描述

In the original BIG PICTURE trial, the analysis of over 6000 subject's CCTA images found significant differences amongst patients of Arabic and south-east Asian descent, with regard to plaque burden, severity and composition. Due to the "all-comers" nature of that trial, the factors of diabetes, previous CVD, and other coronary risk factors were likely confounders in the results. In this trial, those subject selection is screened to eliminate those factors with the goal of working with a more homogenous population to perform the plaque analysis. This study is a multicenter, prospective, post marketing, observational registry study designed to describe frequency and patterns of various risk factors, indications and findings in patients who undergo CCTA.

BIG PICTURE 2 (abbreviated as "BP2") will collect data on patients from a wide variety of imaging sites (inpatient, outpatient, in-clinic CT machine). While the majority of the sites are within the US, the data collection will not be limited to US-only sites. A sub study of BP2 will perform a remote short follow-up questionnaire of subjects who were in the original Big PICTURE study.

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Plaque characteristics

时间窗: Immediately after scan

Total plaque burden, composition, location, severity and myocardial perfusion deficits

次要结局

  • MACE endpoints(2 years (or more))

研究者

发起方
MDDX LLC
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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