SarcopeniaPsoMICSNCT06571643
Psoas Muscle Index (PMI) as a Predictor of Outcomes After Minimally Invasive Cardiac Surgery
An observational study of Sarcopenia and Heart Valve Diseases, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Sarcopenia, Heart Valve Diseases
- What is being tested?
- Lower Abdomen MRI
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Cardiac surgery patients undergoing heart valve surgery via a minimally invasive approach
Who may be able to join
- Elderly patients (≥ 65 years old)
- Able to take consent
- Listed for minimally invasive cardiac surgery
- Elective and urgent procedures included
- Able to undergo MRI
Who cannot join
- Full median sternotomy approach
- Emergency procedures
- Unable to take consent
- Unable to undergo MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psoas Muscle Index (PMI) as a Predictor of Mobilisation and Postoperative Length of Stay 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.
Read the detailed description
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)
- Conditions
- Sarcopenia, Heart Valve Diseases
- Being tested
- Lower Abdomen MRI
- Keywords
- Minimally invasive cardiac surgery, Psoas Muscle Index
- Medical subject headings
- Sarcopenia, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Abdomen MRIOther
The patients will undergo a lower abdomen MRI to assess the size of the psoas muscle and derive the PMI
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Intensive care unit (ITU) stay
Total number of hours spent in ITU after the primary (indexed) cardiac operation
Measured: perioperatively/periprocedurally
Postoperative overall length of stay
Total number of days spent in hospital after the primary (indexed) cardiac operation
Measured: perioperatively/periprocedurally
Mobilization time
Time to mobilization after the primary (indexed) cardiac operation defined as standing up or sitting down for at least 3 consecutive hours
Measured: perioperatively/periprocedurally
Secondary outcomes (3)
Postoperative mortality
In hospital mortality after the primary (indexed) cardiac operation
Measured: perioperatively/periprocedurally
Long term mortality
Mortality at the latest follow up after the primary (indexed) cardiac operation
Measured: at 1 year
Postoperative Complications
Any surgical related postoperative complication related to the primary (indexed) cardiac operation
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571643
- Sponsor's protocol ID
- PsoMICS L2097
- Acronym
- PsoMICS
- Status last verified
- Aug 2024
- First submitted
- 16 May 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benedek Z, Todor-Boer S, Kocsis L, Bauer O, Suciu N, Coros MF. Psoas Muscle Index Defined by Computer Tomography Predicts the Presence of Postoperative Complications in Colorectal Cancer Surgery. Medicina (Kaunas). 2021 May 11;57(5):472. doi: 10.3390/medicina57050472.
PubMed 34064607Bruno VD, Zakkar M. Psoas muscle index: a novel instrument in planning the treatment of severe aortic stenosis in frail patients. J Thorac Dis. 2018 Nov;10(Suppl 33):S4156-S4158. doi: 10.21037/jtd.2018.10.80. No abstract available.
PubMed 30631580Hawkins RB, Mehaffey JH, Charles EJ, Kern JA, Lim DS, Teman NR, Ailawadi G. Psoas Muscle Size Predicts Risk-Adjusted Outcomes After Surgical Aortic Valve Replacement. Ann Thorac Surg. 2018 Jul;106(1):39-45. doi: 10.1016/j.athoracsur.2018.02.010. Epub 2018 Mar 9.
PubMed 29530777Mamane S, Mullie L, Piazza N, Martucci G, Morais J, Vigano A, Levental M, Nelson K, Lange R, Afilalo J. Psoas Muscle Area and All-Cause Mortality After Transcatheter Aortic Valve Replacement: The Montreal-Munich Study. Can J Cardiol. 2016 Feb;32(2):177-82. doi: 10.1016/j.cjca.2015.12.002. Epub 2015 Dec 9.
PubMed 26821840Okamura H, Kimura N, Tanno K, Mieno M, Matsumoto H, Yamaguchi A, Adachi H. The impact of preoperative sarcopenia, defined based on psoas muscle area, on long-term outcomes of heart valve surgery. J Thorac Cardiovasc Surg. 2019 Mar;157(3):1071-1079.e3. doi: 10.1016/j.jtcvs.2018.06.098. Epub 2018 Jul 27.
PubMed 30139644Paknikar R, Friedman J, Cron D, Deeb GM, Chetcuti S, Grossman PM, Wang S, Englesbe M, Patel HJ. Psoas muscle size as a frailty measure for open and transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2016 Mar;151(3):745-751. doi: 10.1016/j.jtcvs.2015.11.022. Epub 2015 Nov 21.
PubMed 26896357Raiche M, Hebert R, Dubois MF. PRISMA-7: a case-finding tool to identify older adults with moderate to severe disabilities. Arch Gerontol Geriatr. 2008 Jul-Aug;47(1):9-18. doi: 10.1016/j.archger.2007.06.004. Epub 2007 Aug 27.
PubMed 17723247Rodge GA, Goenka U, Jajodia S, Agarwal R, Afzalpurkar S, Roy A, Goenka MK. Psoas Muscle Index: A Simple and Reliable Method of Sarcopenia Assessment on Computed Tomography Scan in Chronic Liver Disease and its Impact on Mortality. J Clin Exp Hepatol. 2023 Mar-Apr;13(2):196-202. doi: 10.1016/j.jceh.2022.12.002. Epub 2022 Dec 9.
PubMed 36950487Walston JD. Sarcopenia in older adults. Curr Opin Rheumatol. 2012 Nov;24(6):623-7. doi: 10.1097/BOR.0b013e328358d59b.
PubMed 22955023Xu JY, Li C, Zhang H, Liu Y, Wei JM. Total Psoas Area Index is Valuable to Assess Sarcopenia, Sarcopenic Overweight/Obesity and Predict Outcomes in Patients Undergoing Open Pancreatoduodenectomy. Risk Manag Healthc Policy. 2020 Jul 9;13:761-770. doi: 10.2147/RMHP.S257677. eCollection 2020.
PubMed 32753989Wu XL, Shen J, Danzeng CD, Xu XS, Cao ZX, Jiang W. CT psoas calculations on the prognosis prediction of emergency laparotomy: a single-center, retrospective cohort study in eastern Asian population. World J Emerg Surg. 2022 Jun 3;17(1):31. doi: 10.1186/s13017-022-00435-x.
PubMed 35655215Yamashita M, Kamiya K, Matsunaga A, Kitamura T, Hamazaki N, Matsuzawa R, Nozaki K, Tanaka S, Nakamura T, Maekawa E, Masuda T, Ako J, Miyaji K. Prognostic Value of Psoas Muscle Area and Density in Patients Who Undergo Cardiovascular Surgery. Can J Cardiol. 2017 Dec;33(12):1652-1659. doi: 10.1016/j.cjca.2017.10.009. Epub 2017 Oct 16.
PubMed 29173605Zuckerman J, Ades M, Mullie L, Trnkus A, Morin JF, Langlois Y, Ma F, Levental M, Morais JA, Afilalo J. Psoas Muscle Area and Length of Stay in Older Adults Undergoing Cardiac Operations. Ann Thorac Surg. 2017 May;103(5):1498-1504. doi: 10.1016/j.athoracsur.2016.09.005. Epub 2016 Nov 15.
PubMed 27863730
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoas Muscle Index (PMI) as a Predictor of Mobilisation and Postoperative Length of Stay After Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06571643
- Acronym / sponsor ID
- PsoMICS / PsoMICS L2097
- Conditions
- Sarcopenia, Heart Valve Diseases
- Keywords
- Minimally invasive cardiac surgery, Psoas Muscle Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Cardiac surgery patients undergoing heart valve surgery via a minimally invasive approach
Key inclusion criteria (5 listed)
- Elderly patients (≥ 65 years old)
- Able to take consent
- Listed for minimally invasive cardiac surgery
- Elective and urgent procedures included
- Able to undergo MRI
Key exclusion criteria (4 listed)
- Full median sternotomy approach
- Emergency procedures
- Unable to take consent
- Unable to undergo MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower Abdomen MRIThe patients will undergo a lower abdomen MRI to assess the size of the psoas muscle and derive the PMI | Other | – |
Primary outcome
Postoperative Intensive care unit (ITU) stay
Time frame: perioperatively/periprocedurally
Total number of hours spent in ITU after the primary (indexed) cardiac operation
Postoperative overall length of stay
Time frame: perioperatively/periprocedurally
Total number of days spent in hospital after the primary (indexed) cardiac operation
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
3 secondary outcomes
Postoperative mortality
Time frame: perioperatively/periprocedurally
Long term mortality
Time frame: at 1 year
Postoperative Complications
Time frame: at 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 34064607Benedek Z, Todor-Boer S, Kocsis L, Bauer O, Suciu N, Coros MF. Psoas Muscle Index Defined by Computer Tomography Predicts the Presence of Postoperative Complications in Colorectal Cancer Surgery. Medicina (Kaunas). 2021 May 11;57(5):472. doi: 10.3390/medicina57050472.
- Background: PubMed 30631580Bruno VD, Zakkar M. Psoas muscle index: a novel instrument in planning the treatment of severe aortic stenosis in frail patients. J Thorac Dis. 2018 Nov;10(Suppl 33):S4156-S4158. doi: 10.21037/jtd.2018.10.80. No abstract available.
- Background: PubMed 29530777Hawkins RB, Mehaffey JH, Charles EJ, Kern JA, Lim DS, Teman NR, Ailawadi G. Psoas Muscle Size Predicts Risk-Adjusted Outcomes After Surgical Aortic Valve Replacement. Ann Thorac Surg. 2018 Jul;106(1):39-45. doi: 10.1016/j.athoracsur.2018.02.010. Epub 2018 Mar 9.
- Background: PubMed 26821840Mamane S, Mullie L, Piazza N, Martucci G, Morais J, Vigano A, Levental M, Nelson K, Lange R, Afilalo J. Psoas Muscle Area and All-Cause Mortality After Transcatheter Aortic Valve Replacement: The Montreal-Munich Study. Can J Cardiol. 2016 Feb;32(2):177-82. doi: 10.1016/j.cjca.2015.12.002. Epub 2015 Dec 9.
- Background: PubMed 30139644Okamura H, Kimura N, Tanno K, Mieno M, Matsumoto H, Yamaguchi A, Adachi H. The impact of preoperative sarcopenia, defined based on psoas muscle area, on long-term outcomes of heart valve surgery. J Thorac Cardiovasc Surg. 2019 Mar;157(3):1071-1079.e3. doi: 10.1016/j.jtcvs.2018.06.098. Epub 2018 Jul 27.
- Background: PubMed 26896357Paknikar R, Friedman J, Cron D, Deeb GM, Chetcuti S, Grossman PM, Wang S, Englesbe M, Patel HJ. Psoas muscle size as a frailty measure for open and transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2016 Mar;151(3):745-751. doi: 10.1016/j.jtcvs.2015.11.022. Epub 2015 Nov 21.
- Background: PubMed 17723247Raiche M, Hebert R, Dubois MF. PRISMA-7: a case-finding tool to identify older adults with moderate to severe disabilities. Arch Gerontol Geriatr. 2008 Jul-Aug;47(1):9-18. doi: 10.1016/j.archger.2007.06.004. Epub 2007 Aug 27.
- Background: PubMed 36950487Rodge GA, Goenka U, Jajodia S, Agarwal R, Afzalpurkar S, Roy A, Goenka MK. Psoas Muscle Index: A Simple and Reliable Method of Sarcopenia Assessment on Computed Tomography Scan in Chronic Liver Disease and its Impact on Mortality. J Clin Exp Hepatol. 2023 Mar-Apr;13(2):196-202. doi: 10.1016/j.jceh.2022.12.002. Epub 2022 Dec 9.
- Background: PubMed 22955023Walston JD. Sarcopenia in older adults. Curr Opin Rheumatol. 2012 Nov;24(6):623-7. doi: 10.1097/BOR.0b013e328358d59b.
- Background: PubMed 32753989Xu JY, Li C, Zhang H, Liu Y, Wei JM. Total Psoas Area Index is Valuable to Assess Sarcopenia, Sarcopenic Overweight/Obesity and Predict Outcomes in Patients Undergoing Open Pancreatoduodenectomy. Risk Manag Healthc Policy. 2020 Jul 9;13:761-770. doi: 10.2147/RMHP.S257677. eCollection 2020.
- Background: PubMed 35655215Wu XL, Shen J, Danzeng CD, Xu XS, Cao ZX, Jiang W. CT psoas calculations on the prognosis prediction of emergency laparotomy: a single-center, retrospective cohort study in eastern Asian population. World J Emerg Surg. 2022 Jun 3;17(1):31. doi: 10.1186/s13017-022-00435-x.
- Background: PubMed 29173605Yamashita M, Kamiya K, Matsunaga A, Kitamura T, Hamazaki N, Matsuzawa R, Nozaki K, Tanaka S, Nakamura T, Maekawa E, Masuda T, Ako J, Miyaji K. Prognostic Value of Psoas Muscle Area and Density in Patients Who Undergo Cardiovascular Surgery. Can J Cardiol. 2017 Dec;33(12):1652-1659. doi: 10.1016/j.cjca.2017.10.009. Epub 2017 Oct 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Heart Valve Diseases, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vito D Bruno, MD, PhD (0283500010 ext. 6748, vitodomenico.bruno@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Intensive care unit (ITU) stay (time frame: perioperatively/periprocedurally). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06571643, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.