Cardiac Shock Care Centers: JACC Review Topic of the Week.
Tanveer Rab, Supawat Ratanapo, Karl B Kern...
https://pubmed.ncbi.nlm.nih.gov/30309475Actively Recruiting
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2024-10-29
2000
Participants Needed
1
Research Sites
21 weeks
Total Duration
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
O
Ospedale Civile Ss. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy
Collaborating Sponsor
Researchers are conducting a multicenter study involving patients who have experienced Cardiogenic Shock (CS) to better understand post-acute care programs, patients' functional recovery, return to work, and quality of life. The study will also evaluate new care pathways compared with traditional methods to assess their impact on health outcomes, economic efficiency, and sustainability. This research is funded by the Italian Ministry of Health and coordinated by IRCCS Fondazione Don Gnocchi using data from the Altshock registry, the largest CS registry in Italy. The study focuses on cardiac rehabilitation interventions for CS survivors, including respiratory physiotherapy, muscle strengthening, endurance exercises like walking and cycling, and cardiovascular training. Neuromotor rehabilitation targets muscle loss and nerve damage with specialized exercises and technologies such as functional electrical stimulation, robotics, and virtual reality. Additional support includes cognitive-behavioral therapy for psychological effects, speech and occupational therapy, home reintegration planning, and telerehabilitation to support long-term recovery. Participants will be followed for up to one year after ICU discharge, with assessments at six months measuring survival rates, hospital readmissions, functional recovery, and patient-reported health status. Researchers will collect clinical, economic, and patient experience data to compare outcomes between those receiving post-acute care services and those who do not. The goal is to validate an innovative care model that improves quality of life and reduces mortality while demonstrating cost-effectiveness and healthcare sustainability.
CONDITIONS
Cardiac Rehabilitation in Patients Acutely Managed for Cardiogenic Shock (ENIGMA)
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants who undergo routine care for cardiogenic shock are observed over time to assess survival, hospital readmissions, and functional recovery.
Follow-up visits at 6 months and 1 year
Duration - 6 months
Participants' functional recovery and patient-reported outcomes related to illness severity, disease-specific symptoms, and chronic conditions are assessed.
Assessments at 6 months including functional tests and questionnaires
Total: 1 location
1
Fondazione Don Gnocchi
Milan, Italy, 20148
Actively Recruiting
N
Nuccia Morici, MD
P
Paolo Pedersini, MSc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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