Clinical Implementation of a Novel Decision Support Tool in Patients With Ischemic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 2
- 主要终点
- Number and duration of readmissions within one month after randomization
研究概览
简要总结
The PM-Heart algorithm (PMHeartIHD) is an in-house developed software that predict the survival prognosis for the individual patient hospitalized with ischemic heart disease (IHD) after a coronary arteriography has been performed. The software is intended to be used as a clinical decision support system i.e. the calculated survival prognosis is expected to enhance the quality of the treating physician's therapeutic considerations concerning (minor) adjustments to the patients treatment and follow-up - all within the framework of the current medical guidelines. Thus, the algorithm does not "show the physician specifically what to do", but rather ensures a better knowledgebase for the overall interpretation and choice of management of the patient.
详细描述
To investigate the clinical usefulness of the developed clinical decision support system - the PMHeartIHD algorithm - we wish to investigate whether the clinical use of the algorithm will;
- Improve patient prognosis and,
- Minimize the risk of re-hospitalization,
compared to patients who are treated without the attending/treating physician knowing the algorithm's prognosis?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Hospitalized patients in one of the involved departments of cardiology (see below) with;
- •Ischemic heart disease; the clinical presentation may be stable, worsening/unstable angina, non-ST-elevation myocardial infarction or ST-elevation myocardial infarction, and with - Significant coronary artery lesions or diffuse coronary artery disease on invasive coronary angiography during the admission
排除标准
- •<18 years of age
- •Living outside Denmark
结局指标
主要结局
Number and duration of readmissions within one month after randomization
时间窗: From randomization to the study and up to 1 year hereafter
A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study. All the outcomes listed below will be assessed as a comparison between the "intervention group" and the "control group".
Number and cause of death (all-cause mortality) within one year after randomization
时间窗: From randomization to the study and up to 1 year hereafter
A composite outcome of a) readmissions within one month, and 2) all-cause mortality within one year - for patients randomized to the study.
次要结局
- Total number of days at the hospital incl. hospitalizations during the first year after inclusion(From randomization to the study and up to 1 year hereafter)
- Cardiovascular readmission(s) within 30 days of the randomization(Up to 30 days after randomization to the study.)
- Readmission(s) with acute coronary syndrome(From randomization to the study and up to 1 year hereafter)
- One-year survival(From randomization to the study and up to 1 year hereafter)
- Total number of days the primary hospitalization lasts(From randomization to the study and up to 1 year hereafter)
- Dosages (DDD) of drugs at discharge(Up to 1 year after randomization to study.)
- Number of hospitalizations the first year(From randomization to the study and up to 1 year hereafter)
- Number of cardiac follow-up consultations at the hospital(From randomization to the study and up to 1 year hereafter)
- Readmission(s) within 30 days of the randomization(Up to 30 days after randomization to the study.)
- The algorithm's reception and introduction in clinical use(Before start of clinical study and up to 1 year after randomization to study.)
- Number and type of performed cardiac investigations(From randomization to the study and up to 1 year hereafter)
- Number of check-ups for cardiovascular reasons at the general practitioner(From randomization to the study and up to 1 year hereafter)
- Number of cardiovascular drugs at discharge(From randomization to the study and up to 1 year hereafter)
- The usability of the algorithm(Before start of clinical study and up to 1 year after randomization to study.)
- How, and to what extend, is the algorithm used by the medical staff.(Before start of clinical study and up to 1 year after randomization to study.)
- Incidence of a) new ischemic events, b) arrhythmias, c) and/or heart failure(Up to 1 year after randomization to study.)
- Health economic analyses of implementing the algorithm(Up to 1 year after randomization to study.)
研究者
Henning Bundgaard
Professor of Cardiology, Consultant, MD, DMSc
Rigshospitalet, Denmark