National Plaque Registry and Database
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20,000
- 试验地点
- 11
- 主要终点
- All cause death
研究概览
简要总结
The ultimate goal of this project is to develop a risk score to identify patients with vulnerable coronary atherosclerotic plaques, who are prone to suffer acute coronary syndrome. Early identification of vulnerable plaques may have an enormous impact on public health through primary and secondary prevention of acute myocardial infarction.
Investigators hypothesize that a risk score that incorporates non-invasive coronary CT imaging (calcium score and/or coronary CTA) in combination with clinical characteristics (classical risk prediction models) will improve the identification of patients who are at highest risk to suffer myocardial infarction or sudden cardiac death.
The overall goal of the OPeRA project is to develop, implement and validate a novel risk assessment tool based on image markers and clinical characteristics to identify patients who are at increased risk to suffer myocardial infarction or sudden cardiac death.
详细描述
The primary goals of OPeRA consortium:
To develop a national coronary CTA registry with the collaboration of all major cardiac CT centers of Hungary (Országos Plaque Regiszter és Adatbázis - NatiOnal Plaque Registry and DAtabase, OPeRA).
- To develop a novel risk assessment tool (OPeRA score) based on image markers and clinical characteristics.
- To identify and validate novel vulnerable coronary plaque image markers and assess their prognostic value.
Secondary goals:
- To develop a standardized and structured, national coronary CTA reporting system.
- To establish a national quality control system that monitors the quantity of iodinated contrast agent and the patients' radiation dose.
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
- 否
入选标准
- •Age > 18 years
- •Subject providing written informed consent
- •Scheduled to undergo a clinically indicated coronary CTA
排除标准
- •Age <18 years
- •Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
- •Recent prior myocardial infarction within 30 days prior to coronary CTA or between coronary CTA and ICA
- •Pregnancy or unknown pregnancy status in subject of childbearing potential
- •Subject requires an emergent procedure
- •Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
- •Inability to comply with study procedures
结局指标
主要结局
All cause death
时间窗: 10 years
次要结局
- CAD-related hospitalization(10 years)
- Unstable angina(10 years)
- Myocardial infarction(10 years)
- Target vessel revascularization(10 years)
研究者
Pál Maurovich-Horvat
Assistant Professor
Semmelweis University Heart and Vascular Center