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NCT Number: NCT07764172

Sarcopenia in Acute Ischemic Stroke

The objective of this observational study is to determine the prevalence of sarcopenia in patients aged 50 years and older with acute ischemic stroke, to characterize its trajectory during the acute phase using instrumental verification and functional-cognitive assessments, and to evaluate its impact on functional outcome at three months. The main research question is:

Is the presence of sarcopenia at admission associated with less favorable stroke outcomes, including higher rates of complications and mortality?

Participants receiving standard medical care for acute ischemic stroke will undergo extended functional assessment for sarcopenia, and a subset will additionally undergo cognitive evaluation.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moscow State Budgetary Healthcare Institution "Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department"

Moscow, 115446, Russia

Location status: Recruiting

Location contact

Naida Garabova, PhD

CONTACT

[email protected]

+79611080888

Who can participate

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

Inclusion criteria

  • Age 50 years and older
  • Acute ischemic stroke confirmed by CT or MRI
  • Admission within the first 72 hours
  • Written informed consent and availability of a contact telephone number for follow-up

Exclusion criteria

  • TIA without a visible lesion on neuroimaging; bilateral hemiparesis
  • Amputations or severe contractures that preclude anthropometric assessment
  • Active cancer at stage IV or life expectancy of less than 3 months
  • Neuromuscular diseases; chronic use of systemic glucocorticoids for more than 3 months
  • Pregnancy; refusal to participate

Discontinuation criteria (drop-out)

  • Discharge or death within the first 7 days
  • Withdrawal of consent
  • Transfer to another facility resulting in loss of contact

Treatment and study plan

Primary outcomes

  1. Change from Baseline in Barthel Index for Activities of Daily Living at 14 days

    Time frame: Baseline and 14 days

    Lower scores indicate increasing disability and a greater need for skilled care. Min - 0 ( < 20 - totally dependent), max - 100 ( > 80 - independent).

  2. Change from Baseline in Modified Rankin scale at 90 days

    Time frame: Baseline and 90 days

    Min - 0 (no disability), max - 6 (dead). A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.

Secondary outcomes

  1. Number of Participants with sarcopenia

    Time frame: Baseline

  2. Change from Baseline in arm muscle mass at 14 and 28 days.

    Time frame: Baseline, 14 and 28 days

    Mid-upper arm circumference: measured at the midpoint between the acromion and the olecranon with the arm relaxed (2 measurements) in cm. Arm muscle circumference and area are calculated using the Heymsfield formula.

  3. Change from Baseline in calf circumference at 14 and 28 days

    Time frame: Baseline, 14 and 28 days

    Calf circumference: measured in the seated position, with the knee at a right angle, at the widest part of the non-paretic calf, with the tape snug but without compression (2 measurements) in cm. Calf circumference below 34 cm in men and 33 cm in women is classified as reduced.

  4. Change from Baseline in handgrip strength at 14 and 28 days.

    Time frame: Baseline, 14 and 28 days.

    Handgrip dynamometry: performed in the seated position with the elbow at a right angle; three trials on the non-paretic hand, with the mean value used for analysis. Handgrip strength of the non-paretic hand below 27 kg in men and 16 kg in women is classified as reduced.

  5. Correlations between anthropometric measures and ultrasound/CT parameters

    Time frame: Baseline, 14, 28, and 90 days

  6. Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) at 24 hours, 7 and 14 days.

    Time frame: Baseline, 24 hours, 7 and 14 days.

    Min - 0, max - 42. A higher score means a patients has more severe symptoms. Patients with a score of <4 are highly likely to have good clinical outcomes.

  7. Change from Baseline in Rivermead Mobility Index at 14 and 28 days.

    Time frame: Baseline, 14 and 28 days.

    Min - 0, max - 15. Higher scores indicate better mobility performance. A score of 0 indicates an inability to complete any of the 15 tasks.

  8. Mortality at 14 and 90 days

    Time frame: 14 and 90 days

    Mortality rate at 14 and 90 days

  9. Hospital length of stay

    Time frame: Up to 28 days

    Days. Total number of days spent admitted to the hospital during the index hospital stay, calculated from admission date to final discharge date.

  10. Intensive care unit length of stay

    Time frame: Up to 28 days

    Days. Total number of days spent in the intensive care unit from the time of initial ICU admission to successful transfer or discharge to a step-down unit.

  11. Number of Participants with recurrent events within 90 days

    Time frame: From baseline to 90 days

Sponsors and collaborators

Lead sponsor

University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba)

Other

Registry information

Official study title

Sarcopenia in Patients During the Acute Phase of Ischemic Stroke: Multimodal Assessment and Three-Month Functional Outcomes

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

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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