The ITACARE-P CardioRehab Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- incidence of mace in cardiorehab population
研究概览
简要总结
ITACARE-P CardioRehab Registry is a nationwide observational study conducted in Italy and coordinated by the Fondazione Don Carlo Gnocchi in Milan. It involves multiple hospitals and rehabilitation centers across the country and aims to better understand how cardiac rehabilitation (CR) is delivered to patients recovering from heart conditions (coronary deseases and/or heart failure). CR is a structured program that includes exercise, lifestyle education, and psychological support, and is known to improve recovery, reduce future cardiac events, lower hospital readmissions, and enhance quality of life. Despite strong recommendations from international guidelines, not all eligible patients are referred to CR, and its delivery varies. This study collects real-world data to describe how CR programs are implemented, evaluate patient outcomes, identify subgroups needing tailored care, and support improvements in cardiac care services in Italy. Adults who recently experienced a qualifying heart condition are enrolled and followed during their standard rehabilitation, without any changes to treatment. Data on medical history, risk factors, quality of life, functional improvements, and medication use are collected, with follow-up at 6 and 12 months. Participation involves no added risks, and personal health data is securely managed according to EU GDPR regulations using the REDCap system. The study aims to enhance the quality, consistency, and equity of cardiac rehabilitation across the country.
详细描述
The ITACARE-P CardioRehab Registry, is a nationwide observational project conducted in Italy. It is led by the Fondazione Don Carlo Gnocchi in Milan and involves several hospitals and rehabilitation centers across all the Country.
The main goal of the present study is to better understand how cardiac rehabilitation (CR) is being delivered to patients who have experienced heart-related conditions (coronary deseases or heart failure). Cardiac rehabilitation is a structured program that includes exercise, lifestyle education, and psychological support. It is known to help patients recover faster, reduce the risk of future heart problems, lower hospital readmissions, and improve quality of life.
Despite strong recommendations from international guidelines, not all eligible patients are referred to cardiac rehabilitation, and CR programs are not always delivered in a consistent way. This study aims to collect real-world data to:
- Describe how CR programs are implemented in different hospitals,
- Evaluate whether patients are meeting treatment goals (such as improved fitness, lower cholesterol, or better medication use),
- Identify patient groups that may need different types of care,
- Support future improvements in heart care services in Italy and beyond.
The central idea behind the study is that systematically collecting and analyzing data on patients undergoing cardiac rehabilitation can highlight what works best, help standardize care, and improve long-term health outcomes for people with heart disease. By understanding how care is delivered and what results are achieved, the study aims to improve the quality and equity of cardiac rehabilitation services across Italy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery disease and/or heart failure who meet the current regulatory requirements for appropriateness of referral to cardiac rehabilitation are eligible for enrollment. These patients may be included regardless of whether they are referred to inpatient or outpatient cardiac rehabilitation programs, depending on the clinical setting and care pathway.
排除标准
- •Explicit refusal to participate in the study by the patient;
- •Planned hospital readmission within six months after completion of the cardiac rehabilitation program.
结局指标
主要结局
incidence of mace in cardiorehab population
时间窗: 6 months and 12 months
Evaluate how cardiac rehabilitation (CR) is delivered across Italy and to assess its real-world effectiveness in patients recovering from major cardiovascular events such as coronary deseases or heart failure. A key focus of the study is to measure the incidence of major adverse cardiovascular events (MACE)-including cardiovascular death, recurrent myocardial infarction, stroke, and hospital readmissions-during a 12-month follow-up period.
次要结局
未报告次要终点