Clinical trial NCT06572826: Cardiac Rehabilitation in Patients Acutely Managed for Cardiogenic Shock (ENIGMA)
Official title: A framEwork for aN InteGrated assessMent of cArdiac Rehabilitation Programs in Patients Acutely Managed for Cardiogenic Shock - ENIGMA-shock
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Keywords: Cardiogenic Shock
Rehabilitation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Ospedale Civile Ss. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy
name: Azienda Ospedaliera Brotzu
name: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
name: ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
First posted: 2024-08-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients with Cardiogenic Shock (CS) will be included. The deferred consent is admitted for non-competent patients.

Brief summary: This is a prospective and retrospective multicentre study conducted under the scientific coordination of the IRCCS Fondazione Don Gnocchi and funded by the Italian Ministry of Health (PNRR-MCNT2-2023-12377767). Using the Altshock registry, the largest multicentre Cardiogenic Shock (CS) registry in Italy, which currently has registered more than 1,000 CS patients across Italy, we will recruit patients to: (1) provide a granular assessment of post-acute phase programmes, patients' functional disability, return to work and quality of life, including specific reference to gender; (2) implement specific pathways of care in the post-acute phase; (3) provide a multidimensional assessment, thus validating an innovative model in comparison with the traditional pathway, defining the potential benefits to and impact on economic efficiency and the general sustainability of this therapeutic trajectory.

Detailed description: Study Population: The study will include all consecutive Cardiogenic Shock (CS) patients from the Altshock registry. The primary outcome is all-cause death and readmission-free survival at 6 months and 1 year post-ICU discharge. Secondary outcomes include functional recovery measured by illness severity (using the Medical Research Council Scale and electromyography if needed), disease-specific PROM (Kansas City Cardiomyopathy Questionnaire), and a chronic condition PROM (Long-Term Conditions Questionnaire) at 6 months.

Sample Size: An estimated cohort of 2000 CS patients, with around 1240 survivors, will be studied. This sample allows us to detect a 10% difference in death and readmission-free survival rates between those receiving post-acute care services and those who do not, with 80% power and a 5% significance level.

Validation and Assessment: A mixed-method approach will validate the innovative care model, incorporating clinical data, health economics, and professional perceptions. Key performance indicators and a RACI matrix will guide the implementation, with a focus on short- and long-term organizational impacts, economic benefits, and healthcare professional perceptions.

Data Analysis: Quantitative variables will be analyzed using standard statistical methods, and survival analysis will compare groups using Kaplan-Meier curves and log-rank tests. Multivariable Cox models will assess the impact of post-acute care services on outcomes. Economic analyses will involve cost-effectiveness and budget impact assessments.

Rehabilitation Intervention: Post-acute care, including cardiac and neuromotor rehabilitation, is critical for CS patients to prevent complications and rehospitalization. The rehabilitation program will include respiratory physiotherapy, muscle strengthening, endurance training, cardiovascular exercises, and secondary prevention strategies. Neuromotor rehabilitation will address sarcopenia and polyneuropathies with targeted exercises and advanced technologies like robotics and FES.

Expected Outcomes: The ENIGMA project aims to improve CS patient outcomes by transforming post-acute care, reducing mortality, enhancing quality of life, and proving the cost-effectiveness and sustainability of innovative care pathways.

Eligibility criteria: Inclusion Criteria:

• All consecutive patients with a clinical diagnosis of Cardiogenic Shock.

Exclusion Criteria:

• Refusal to give informed consent.

Primary outcomes:
measure: All-cause of death
timeFrame: 1 Year
measure: Readmission in hospital for any cause
timeFrame: 1 Year
Secondary outcomes:
measure: Severity of critical illness polyneuropathy
timeFrame: 6-months
measure: Disease-specific PROM
timeFrame: 6-Months
measure: Chronic-condition PROM
timeFrame: 6-months
measure: PREMS: patient's opinion regarding their clinical service.
timeFrame: 6-months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Don Gnocchi
Study officials:
References:
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