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NCT Number: NCT06571643

Psoas Muscle Index (PMI) as a Predictor of Outcomes After Minimally Invasive Cardiac Surgery

Sarcopenia or muscle loss and function is a component of the frailty syndrome. In this sense, frailty is becoming an important risk factor in predicting outcomes after major surgery and is defined as a geriatric syndrome of decreased reserve and resiliency to stressors that have been associated with adverse health outcomes in older adults. Despite its potentially relevant role in predicting postoperative recovery, frailty is rarely evaluated before surgery, and this is partially due to the low reliability of the most used frailty scores. Therefore, improvement in the frailty evaluation would be beneficial during the preoperative assessment of major surgeries. Sarcopenia, or the decline of skeletal muscle tissue with age, is one of the most important causes of functional decline and loss of independence in older adults and low muscle mass is a core component of frailty that has the advantage of being objectively quantifiable regardless of mobility, disability, or illness acuity. Psoas Muscle (PM) mass is an important parameter for evaluating muscle mass and has been previously correlated to frailty with a negative impact on the postoperative outcomes after major surgery and Psoas Muscle mass Index (PMI) is an easily available parameter for evaluating muscle mass and has already been demonstrated to be effective in predicting outcomes in different clinical settings. PMI has also been shown to be an effective predictor of outcomes in cardiac surgery although there are no studies specifically focusing on minimally invasive cardiac surgery. With this study, the investigators aim to investigate the relevance of PMI as a predictor of postoperative mobilisation, hospital length of stay and clinical recovery after major cardiac surgery conducted via a minimally invasive approach.

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Key information

Conditions

Sarcopenia Atrophy Cardiovascular Diseases Heart Diseases Heart Valve Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Milan, 20173, Italy

About this study

This is a prospective, controlled, observational single-centre study of patients undergoing minimally invasive heart valve surgery at the department of minimally invasive cardiac surgery of the IRCCS Galeazzi Sant'Ambrogio Hospital, in Milan (Italy).

The primary endpoint is to evaluate the role of psoas muscle index (PMI) in predicting length of stay and early mobility after heart valve surgery via a minimally invasive approach.

25 consecutive participants patients undergoing minimally invasive cardiac surgery will be assessed with a lower abdomen MRI before the surgery to evaluate the diameter of the psoas muscle and therefore assess the Psoas Muscle Index (PMI). Frailty will be evaluated using the PRISMA-7 questionnaire.

PMI value will be correlated with the main outcomes via regression methods and adjusted for covariates.

The participants will be consented to the study before the cardiac surgery operation (indexed procedure). Surgeries will include aortic, mitral and tricuspid valve operations conducted either via a mini-thoracotomy or a mini-sternotomy approach and every patient will receive routine preoperative, operative and postoperative cardiac surgery care. In addition to standard cardiac surgery clinical variables, the investigators will collect data on:

  • Total intubation hours
  • Total Intensive Treatment Unit (ITU) length of stay
  • Total postoperative length of hospital stay
  • Time between end of surgery and first mobilisation (see below)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly patients (≥ 65 years old)
  • Able to take consent
  • Listed for minimally invasive cardiac surgery
  • Elective and urgent procedures included
  • Able to undergo MRI

Exclusion criteria

  • Full median sternotomy approach
  • Emergency procedures
  • Unable to take consent
  • Unable to undergo MRI

Treatment and study plan

Lower Abdomen MRI

Other

The patients will undergo a lower abdomen MRI to assess the size of the psoas muscle and derive the PMI

Primary outcomes

  1. Postoperative Intensive care unit (ITU) stay

    Time frame: perioperatively/periprocedurally

    Total number of hours spent in ITU after the primary (indexed) cardiac operation

  2. Postoperative overall length of stay

    Time frame: perioperatively/periprocedurally

    Total number of days spent in hospital after the primary (indexed) cardiac operation

  3. Mobilization time

    Time frame: perioperatively/periprocedurally

    Time to mobilization after the primary (indexed) cardiac operation defined as standing up or sitting down for at least 3 consecutive hours

Secondary outcomes

  1. Postoperative mortality

    Time frame: perioperatively/periprocedurally

    In hospital mortality after the primary (indexed) cardiac operation

  2. Long term mortality

    Time frame: at 1 year

    Mortality at the latest follow up after the primary (indexed) cardiac operation

  3. Postoperative Complications

    Time frame: at 30 days

    Any surgical related postoperative complication related to the primary (indexed) cardiac operation

Study contacts

Contact information is provided by the study sponsor or research team.

Vito D Bruno, MD, PhD

CONTACT

[email protected]

0283500010 ext. 6748

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

Psoas Muscle Index (PMI) as a Predictor of Mobilisation and Postoperative Length of Stay After Minimally Invasive Cardiac Surgery

Acronym: PsoMICS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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