An observational study in Heart Failure, Acute Coronary Syndromes (ACS) and Cardiac Surgery, sponsored by Istituti Clinici Scientifici Maugeri SpA. Completed at 2 sites in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Observational
Cardiac rehabilitation is a comprehensive, multidisciplinary intervention aimed at reducing disability and improving functional recovery in patients following a cardiovascular event. In older patients, comprehensive multidimensional assessment using the Multidimensional Prognostic Index (MPI) provides a standardized approach to prognostic risk stratification.
The primary aim of this study is to determine whether an inpatient cardiac rehabilitation program implemented following a cardiovascular event can reduce the proportion of patients classified as being at high prognostic risk according to the MPI.
The study will also assess whether the benefits achieved through cardiac rehabilitation are maintained at the three-month follow-up. Finally, the study will evaluate the prognostic significance of changes in MPI score in response to the cardiac rehabilitation intervention.
The aim of this study is to assess frailty status, measured using the Multidimensional Prognostic Index (MPI), in patients admitted to an inpatient cardiac rehabilitation program following an acute cardiovascular event.
Eligible patients who meet the inclusion criteria and provide written informed consent will undergo frailty assessment using the MPI within 48 hours of admission to the cardiac rehabilitation unit (baseline visit). The MPI assessment will be repeated at hospital discharge (Discharge Day). Finally, 90 days after discharge (Day 90), frailty status will be reassessed by telephone using the validated TELE-MPI version adapted for remote administration.
MPI Assessment
The MPI is based on the following eight domains:
Activities of Daily Living (ADL) Instrumental Activities of Daily Living (IADL) Exton-Smith Scale (ESS) Short Portable Mental Status Questionnaire (SPMSQ) Mini Nutritional Assessment, Short Form (MNA-SF) Cumulative Illness Rating Scale, Comorbidity Index (CIRS-CI) Number of medications Living status
The final MPI score is calculated according to the following procedure:
Each domain is classified into one of three risk categories. Each category is assigned a value (0, 0.5, or 1). The values from all completed domains are summed. The MPI score is considered valid only when at least six domains have been completed.
The sum of the assigned values is divided by the number of completed domains.
The resulting score is interpreted as follows:
MPI-1 (0.00-0.33): Low risk of adverse clinical outcomes; the individual is not considered frail.
MPI-2 (0.34-0.66): Moderate risk of adverse clinical outcomes; the individual is considered pre-frail.
MPI-3 (0.67-1.00): High risk of adverse clinical outcomes; the individual is considered frail.
TELE-MPI Assessment
The TELE-MPI includes the following domains:
Activities of Daily Living (ADL) Instrumental Activities of Daily Living (IADL) Barthel Mobility Index (Barthel MOB) Short Portable Mental Status Questionnaire (SPMSQ) Mini Nutritional Assessment, Short Form (MNA-SF) Cumulative Illness Rating Scale, Comorbidity Index (CIRS-CI) Number of medications Living status
The TELE-MPI score is calculated using the same procedure described for the standard MPI assessment, with classification into MPI-1, MPI-2, and MPI-3 categories.
Primary Objective
The primary objective of the study is to determine whether participation in an inpatient cardiac rehabilitation program is associated with an improvement in frailty status, assessed by MPI, from admission to discharge. Frailty status will be evaluated at the following time points:
Admission to the rehabilitation unit (Baseline) Hospital discharge (Discharge Day) Day 90 after discharge Secondary Objectives
A one-year follow-up will be conducted to evaluate the association between frailty status at discharge and subsequent clinical outcomes, including:
All-cause mortality Cardiovascular mortality Hospital readmissions
The predictive value of MPI and TELE-MPI scores for adverse clinical outcomes during follow-up will also be investigated.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 202 is close to the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 126 studies on the registry; 51 are open to participants now.
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The study will enroll consecutive patients admitted to the Cardiac Rehabilitation Unit of ICS Maugeri for an intensive inpatient cardiac rehabilitation program following an acute cardiovascular event.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proportion of patients classified as being at high risk according to Multidimensional Prognostic Index (MPI)
The primary endpoint is the prevalence of frailty, defined as an MPI score between 0.67 and 1.00, assessed at: Baseline (admission to the cardiac rehabilitation unit); Hospital discharge; Three months after discharge. Patients with an MPI score ranging from 0.67 to 1.00 will be classified as frail. Frailty prevalence at each time point will be calculated as the proportion of patients with an MPI score between 0.67 and 1.00 divided by the total number of evaluated patients, and will be expressed as a percentage: Frailty prevalence (%) = (Number of patients with MPI 0.67-1.00 / Total number of assessed patients) × 100.
Time frame: Baseline (day 1), discharge (up to five days), and 3 months (Day 90)
Prognostic value of the Multidimensional Prognostic Index (MPI) score at discharge for 1-year all-cause mortality.
The association between discharge MPI score and one-year event-free survival (free from all-cause mortality and hospital readmission) will be investigated using Cox proportional hazards regression analysis. Hazard ratios and 95% confidence intervals will be calculated to quantify the increase in the risk of death or hospitalization associated with each 0.1-point increment in MPI score. Higher MPI values are expected to reflect a greater degree of frailty and a correspondingly higher risk of adverse clinical outcomes.
Time frame: 1 year
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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