About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Explicit refusal to participate in the study by the patient;
Planned hospital readmission within six months after completion of the cardiac rehabilitation program.
Trial population
cardiological rehabilitation patients with heart conditions (heart coronary deseases and/or heart failure).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
incidence of mace in cardiorehab population
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator
ASST Crema
Collaborator
IRCCS Ospedale San Raffaele
Collaborator
AORN Sant'Anna e San Sebastiano - Caserta
Collaborator
IRCCS Fondazione Don Gnocchi-Firenze
Collaborator
Fondazione Don Gnocchi Parma
Collaborator
U.O.S. Riabilitazione Cardiologica Area Sud Azienda USL Toscana
Collaborator
S.O.D. Riabilitazione Cardiologica Azienda Ospedaliero Universitaria Careggi Firenze
Collaborator
UOSD Cardiologia Riabilitativa Azienda Ospedaliera San Giovanni-Addolorata
Collaborator
IRCCS Istituti clinici Maugeri, Istituto di Montescano
Collaborator
IRCCS Istituti clinici Maugeri, Istituto di Pavia
Collaborator
IRCCS Istituti clinici Maugeri, Istituto di Gattico-Veruno
Collaborator
Struttura complessa Riabilitazione Cardiologica
Collaborator
Casa di cura villa gemma
Collaborator
Cardiologia Riabilitativa Tagliacozzo
Collaborator
ASST Brianza
Collaborator
Riabilitazione del Cardiopatico
Collaborator
UOS Cardiologia Riabilitativa ULSS Serenissima
Collaborator
Ospedale Riabilitativo di Alta Specializzazione
Collaborator
Istituto clinico Maugeri Lumezzane
Collaborator
U.O.C. Cardiologia ASL 3 Genovese
Collaborator