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
- 2
- 主要终点
- Proportion of Participants Achieving Condition-Specific Therapeutic Goals
研究概览
简要总结
The 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 centres across the country and aims to better understand how cardiac rehabilitation (CR) is delivered to patients recovering from heart conditions (coronary artery disease and/or heart failure). CR is a structured programme 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 programmes are implemented, evaluate whether patients meet recommended treatment targets (such as lower cholesterol in coronary patients or reduced heart-failure blood markers), assess 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 capacity, and medication use are collected, with follow-up at 6 and 12 months. Participation involves no added risks, and personal health data are securely managed in accordance with 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 centres across the country. The main goal of the study is to better understand how cardiac rehabilitation (CR) is delivered to patients who have experienced heart-related conditions (coronary artery disease or heart failure). CR is a structured programme 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 CR, and programmes are not always delivered consistently. This study collects real-world data to:
- Describe how CR programmes are implemented across different hospitals;
- Evaluate whether patients meet recommended treatment targets (such as improved fitness, lower cholesterol in coronary patients, reduced heart-failure blood markers, and appropriate medication use);
- Identify patient groups that may need different types of care;
- Support future improvements in cardiac care services in Italy and beyond.
The central idea is that systematically collecting and analysing data on patients undergoing CR can highlight what works best, help standardise care, and improve long-term outcomes for people with heart disease. Adults who recently had a qualifying heart condition are included. This is not a treatment trial, and no experimental therapies are given; the study observes what happens during standard care, and patients continue their normal rehabilitation. Information collected includes: basic personal and medical data (e.g., age, blood pressure, cholesterol); risk factors (e.g., smoking, diabetes, weight); emotional well-being and quality of life; functional capacity (e.g., exercise capacity); and medication use. Patients are contacted by telephone at 6 and 12 months after the programme to assess their health and any additional cardiac events.
There are no added risks, as the study does not modify usual care. While there are no direct personal benefits, participants may benefit from closer tracking of their health indicators, and their participation helps improve care for future patients. All personal health data are kept confidential and protected in accordance with EU data protection regulations (GDPR). A secure online system (REDCap) is used to collect and manage the data, which are pseudonymised so that individuals cannot be directly identified; only authorised staff have access, and the data are used solely for scientific and quality-improvement purposes.
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
- •Adults (≥18 years) with coronary artery disease and/or heart failure following an acute event, meeting current national regulatory requirements for appropriateness of referral to cardiac rehabilitation (early post-acute referral); Admitted to an inpatient, outpatient, or Complex Outpatient Macro-Activity (MAC) cardiac rehabilitation programme, according to the clinical setting and care pathway; Provision of written informed consent.
排除标准
- •Explicit refusal to participate in the study; Indication for cardiac rehabilitation solely following isolated valvular surgery; Highly unfavourable short-term prognosis (e.g., terminal illness); Planned elective hospital readmission within six months after completion of the cardiac rehabilitation programme.
研究组 & 干预措施
cardiorehab patients
cardiological rehabilitation patients with heart conditions (heart coronary diseases and/or heart failure).
结局指标
主要结局
Proportion of Participants Achieving Condition-Specific Therapeutic Goals
时间窗: At the completion of the cardiac rehabilitation program (expected average of 2 to 8 weeks).
This composite outcome measures the proportion of participants who achieve either of the following condition-specific goals: an LDL-C target of \<55 mg/dL in patients with Coronary Artery Disease (CAD), OR a ≥30% reduction from baseline in NT-proBNP (or BNP) levels in patients with Heart Failure (HF)
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
- Change in perceived health status: EQ-VAS.(Admission, Discharge, at 6 and 12 months of follow-up)
- Change in physical performance: Short Physical Performance Battery (SPPB) score.(From beginning to end of the cardiac rehabilitation programme (admission to discharge).)
- Incidence of major adverse cardiovascular events (MACE)(in a follow-up of 12 months.)
- Incidence of all-cause deaths(in a follow-up of 12 months.)
- Incidence of hospital readmission (all-cause and cardiovascular).(In a follow-up of 12 months.)
- Risk-factor control : Blood pressure control, glycaemic control (HbA1c), smoking cessation, and physical activity level.(From admission to discharge, and at 6 and 12 months.)
- Change in functional capacity 6-minute walk test (6MWT) distance (metres).(From beginning to end of the cardiac rehabilitation programme (admission to discharge).)
- Change in cardiorespiratory fitness: peak VO₂ on cardiopulmonary exercise testing (where performed).(From beginning to end of the cardiac rehabilitation programme (admission to discharge).)
- Change in depressive symptoms: PHQ-9 (PHQ-2 at follow-up)(From admission to discharge, and at 6 and 12 months.)
- Change in anxiety symptoms: GAD-7 (GAD-2 at follow-up).(From admission to discharge, and at 6 and 12 months.)
- Medication adherence: MGLS-4 and rate of evidence-based pharmacological therapy.(At 6 and 12 months of follow-up.)
- CR quality indicators (EAPC): Referral to CR, time from hospital discharge to CR initiation, individualized exercise prescription, and programme completion/dropout rate.(From beginning to end of the cardiac rehabilitation programme (admission to discharge).)
