Skeletal Muscle Mass on Prognosis and Recovery in Clinical Trial

NCT07034170 | Enrolling By Invitation

• 1 other identifier: 202501085RIND
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research project is to develop an automated muscle mass measurement system based on computed tomography (CT) images using deep learning and artificial intelligence, and to construct a prognostic prediction model for patients who have experienced cardiac arrest and undergone resuscitation. The model will be validated using multicenter registry data and medical imaging. Furthermore, a clinical trial involving core muscle rehabilitation for post-resuscitation patients will be conducted to evaluate both short-term and long-term outcomes, aiming to comprehensively understand the impact of muscle mass on the prognosis of patients after cardiac arrest.

Conditions

Out of Hospital Cardiac Arrest; Inhospital Cardiac Arrest

Keywords

cardiac arrest; Skeletal muscle mass; rehabilitation

Outcome Measures

Primary Outcomes (1)

• skeletal muscle mass

  21 days

Study Arms (2)

control group

NO INTERVENTION

Intervention Group

EXPERIMENTAL

Behavioral: Enhanced Rehabilitation Program

Interventions

Enhanced Rehabilitation Program BEHAVIORAL

Participants in the intervention group receive an enhanced rehabilitation program, including muscular electrical stimulation, guided active rehabilitation sessions, and structured physical engagement during periods of consciousness. The intervention is designed to promote functional improvement in post-cardiac arrest patients.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-traumatic adult patients who experienced sudden cardiac arrest
• Achieved sustained return of spontaneous circulation (ROSC) for more than five minutes following successful resuscitation
• Admitted to the ICU
• Survived beyond 72 hours without successful weaning from mechanical ventilation

You may not qualify if:

• Age under 18 years
• Pregnancy
• Expected to be weaned from mechanical ventilation within 48 hours
• Terminal-stage cancer or unwillingness to receive aggressive treatment
• Unavailability of ICU care due to overcrowding in the emergency intensive care unit
• Refusal to participate in the study by the patient or family members
• Presence of an implanted pacemaker or defibrillator
• Open wounds, severe edema, or deep vein thrombosis in the lower limbs
• Pre-arrest status limited to wheelchair use or bedridden, unable to ambulate

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Emergency Medicine, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel assignment trial in which participants are allocated to study arms based on the month of admission. Patients admitted during even-numbered months are assigned to the intervention group, while those admitted during odd-numbered months are assigned to the control group.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)