Effect of Intensive Medical Treatment on Quantified Coronary Artery Plaque Components With Serial Coronary CTA in Women With NonObstructive CAD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Change in coronary plaque inflammation (measured as CT attenuation of Pericoronary adipose tissue)
研究概览
简要总结
In this study, quantitative characterization of plaque using coronary computed tomographic angiography (CTA) will be used to determine if women who were treated with intensive medical therapy have a greater reduction in the amount and type of cholesterol plaque compared to women receiving usual care and if this results in beneficial changes in clinical symptoms. The study will provide an understanding of how intensive medical therapy works in providing clinical benefit in women with nonobstructive plaque.
详细描述
This is an ancillary substudy of the WARRIOR Trial (NCT03417388), a multi-site, PROBE design, that will evaluate an intensive statin/ACE-I (or ARB)/aspirin treatment strategy (IMT) vs. primary prevention risk factor therapy treatment strategy (UC) in 4,422 symptomatic (chronic angina or equivalent) women with non-obstructive CAD (<50% diameter narrowing).
In this ancillary substudy, 204 patients will be recruited from the WARRIOR trial with 102 patients from each of the treatment groups (IMT vs UC). From this cohort, 102 patients per treatment group, most compliant with WARRIOR protocol will undergo a CTA from any time from 2 years post-randomization up to the end of the main WARRIOR study; with changes in plaque and PCAT characteristics quantified.
The main aims are as follows:
- To compare changes in coronary plaque characteristics and their hemodynamic significance using CTA in WARRIOR women treated with IMT vs UC;
- To compare changes in plaque inflammation-related characteristics in PCAT in WARRIOR women treated with IMT with statin in combination with angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) medications vs UC;
- To relate plaque burden and plaque composition, CT flow reserve, and PCAT density changes to angina score (Seattle Angina Questionnaire [SAQ]) changes in IMT and UC-randomized WARRIOR women.
Data to be analyzed include CT angiography scans at baseline and Year 3 follow-up and corresponding study data and laboratory tests (e.g. hsCRP); plus, selected data from the main WARRIOR study that are relevant to the present ancillary study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In addition to the inclusion criteria of the WARRIOR trial, only women who meet the following criteria will undergo final CTA at the same sites where they are screened and enrolled.
- •Initial CTA with excellent or good image quality-defined as images where we are able to clearly identify the atherosclerotic plaque. Based on our preliminary assessment, we expect 90% of studies to be included.
- •Measurable plaque with total plaque volume >0mm3; women without significant plaque will not receive additional radiation, and we can detect measurable changes in plaque burden and plaque composition.
排除标准
- •In addition to exclusion criteria of the parent WARRIOR trial, key exclusion criteria are:
- •Non-adherent with IMT. The parent trial is already powered for non-adherence. In our ancillary trial we have built in an exclusion, from final analysis, of an additional 30% who may be nonadherent with IMT or UC.
结局指标
主要结局
Change in coronary plaque inflammation (measured as CT attenuation of Pericoronary adipose tissue)
时间窗: 3 years
Change in pericoronary artery adipose tissue (PCAT) density (CT attenuation of PCAT, in Hounsfield Units) by Autoplaque plaque analysis software
Change in atherosclerotic plaque burden and noncalcified plaque composition
时间窗: 3 years
Change in atherosclerotic plaque burden (%) and noncalcified plaque composition (%) using Autoplaque plaque analysis software
Change in angina score assessed by the Seattle Angina Questionnaire (SAQ)
时间窗: 3 years
Change in angina score quantified by the Seattle Angina Questionnaire (SAQ)
次要结局
未报告次要终点
研究者
Damini Dey
Professor and Scientist, Director of Quantitative Image Analysis, Biomedical Imagng Research Institute
Cedars-Sinai Medical Center