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Multidimensional Longitudinal Study on Neurogenic Complications of Acute Ischemic Stroke (MELINIS Study)

Multidimensional Longitudinal Study on Neurogenic Complications of Acute Ischemic Stroke (MELINIS Study)

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098988
Enrollment
Unknown
Registered
2025-03-17
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

Group of stroke survivors free from neurological complications:none
Group of stroke survivors presenting neurological complications:none

Sponsors

Second Affiliated Hospital of Army Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Patients with acute ischemic stroke confirmed by cranial DWI showing new infarct lesions; 3. Admission within 7 days of symptom onset; 4. Right-handed patients; 5. Written informed consent signed by the patient or their family.

Exclusion criteria

Exclusion criteria: 1. Intracranial hemorrhage confirmed by cranial CT or MRI; 2. History of stroke, traumatic brain injury, intracranial tumor, or brain surgery; 3. Pregnant or breastfeeding women; 4. Patients with a history of infection, autoimmune diseases, or hematological disorders prior to AIS onset; 5. Patients undergoing chronic hemodialysis or with severe renal insufficiency (glomerular filtration rate 220 µmol/L); 6. Patients with advanced-stage diseases resulting in an expected survival of less than 6 months; 7. Patients anticipated to be unable to complete follow-up; 8. History of epilepsy, Parkinson’s disease, depression, and/or other psychiatric disorders or dementia prior to stroke onset, confirmed by a psychiatrist with at least 3 years of clinical experience using the Mini International Neuropsychiatric Interview (MINI); 9. Patients who have severe aphasia or severe cognitive impairment after stroke that limits their ability to complete psychological assessments; 10. Patients currently participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
3 months, 6 months, 1 year mRS Score;MoCA assessment at 7 days, 3 months, 6 months, and 1 year;Hamilton Anxiety Rating Scale (HAMA) scores at 7 days, 3 months, 6 months, and 1 year;DN4 (Douleur Neuropathique 4) questionnaire scores for neuropathic pain at 7 days, 3 months, 6 months, and 1 year;OAB symptom scores at 7 days, 3 months, 6 months, and 1 year;Pittsburgh Sleep Quality Index (PSQI) scores at 7 days, 3 months, 6 months, and 1 year;Bather index at 7 days, 3 months, 6 months, and 1 year;Thyroid function tests at 48 hours, 7 days, and 3 months;

Secondary

MeasureTime frame
The proportion of 3 months, 6 months, 1 year mRS Scores 0-1;The proportion of 3 months, 6 months, 1 year mRS Scores 0-2;The proportion of 3 months, 6 months, 1 year mRS Scores 0-3;Baseline NIHSS score;HDRS scale scores at 7 days, 3 months, 6 months, and 1 year;FSS scale scores at 7 days, 3 months, 6 months, and 1 year;AES scale scores at 7 days, 3 months, 6 months, and 1 year;MMSE scale scores at 7 days, 3 months, 6 months, and 1 year;TICS-m scale scores at 7 days, 3 months, 6 months, and 1 year;Changes in peripheral blood immune cells and subsets at 48 hours, 7 days, and 3 months post-stroke;Post-stroke QT interval prolongation;Cardiac injury markers at 48 hours, 7 days, and 3 months;Complete blood count(CBC) at 48 hours, 7 days, and 3 months;Coagulation Profile (Four-item Panel) and D-dimer Assay;Liver FunctionBlood LipidElectrolyte tests;

Countries

China

Contacts

Public ContactWenzhe Sun

Second Affiliated Hospital of Army Medical University, PLA

sunwenzhe58@163.com+86 159 7147 5860

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026