Health Condition 1: I639- Cerebral infarction, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: Nil: Nil
Sponsors
Datta Meghe Institute Of Higher Education And Research
Eligibility
Inclusion criteria
Inclusion criteria: ESUS Group: 1. Age more than or equal to 18 years 2. Non-lacunar ischemic stroke confirmed on brain imaging (CT or MRI) showing infarct more than 1.5 cm or involving cortical territory 3. Absence of extracranial or intracranial arterial stenosis more than or equal to 50 percent in vessels supplying the ischemic territory (documented on carotid/vertebral ultrasound or CT/MR angiography) 4. Absence of major-risk cardioembolic sources, defined as: o No atrial fibrillation (documented on 12-lead ECG, 24 48 hour Holter monitoring, or continuous telemetry) o No left ventricular thrombus (on echocardiography) o No recent myocardial infarction (less than 3 months) o No mechanical prosthetic valve, rheumatic mitral stenosis, or endocarditis o No atrial myxoma or other cardiac tumor 5. Completion of minimum diagnostic workup: brain imaging, vascular imaging of head/neck, 12-lead ECG, cardiac monitoring more than or equal to 24 hours, transthoracic echocardiography 6. Written informed consent Cardioembolic Stroke Group: 1. Age more than or equal to 18 years 2. Acute ischemic stroke (confirmed on brain CT or MRI) 3. Documented major-risk cardioembolic source, including one or more of: o Atrial fibrillation (paroxysmal, persistent, or permanent) documented on ECG, telemetry, or prolonged monitoring o Left ventricular thrombus on echocardiography o Acute myocardial infarction (within 3 months) o Valvular heart disease (rheumatic, prosthetic, endocarditis) o Dilated cardiomyopathy with ejection fraction less than or equal to 35 percent o Atrial myxoma or other cardiac tumor o Left ventricular dysfunction (EF less than or equal to 40 percent) with regional akinesis 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Hemorrhagic stroke documented on imaging 2. Presence of other definite stroke etiologies: o Arterial dissection (carotid or vertebral) o Vasculitis or reversible cerebral vasoconstriction syndrome o Moyamoya disease o Antiphospholipid syndrome o malignancy-related stroke o Coagulopathy (thrombophilia) 3. Severe medical illness expected to limit survival to less than12 months. 4. Incomplete diagnostic workup. 5. Inability to obtain informed consent or likely unavailability for 3-month follow-up6. Pregnancy or breastfeeding 7. Already enrolled in competing interventional clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comparison of stroke recurrence rates: Incidence of recurrent ischemic strokeat 3months in ESUS vs. cardioembolic stroke group 2. Predictors of stroke recurrence in ESUS: Clinical and radiological factorsindependently associated with stroke recurrence in the ESUS cohort 3. Predictors of stroke recurrence in cardioembolic stroke: Clinical and radiological factors independently associated with stroke recurrence in the cardioembolic strokecohort Timepoint: 4 WEEK Follow-up Mode: In-person clinic visit or telephone contact (if visit not feasible) Data collection: Interval clinical events (stroke, TIA, myocardial infarction, hospitalization) Medication adherence and side effects Repeat NIHSS and mRS Complications related to prior investigation (e.g., post-TEE complications) 12 WEEK Follow-up (Primary Outcome Assessment) Mode: In-person clinic visit (preferred) or comprehensive telephone interview | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Comparison of baseline clinical parameters 2.Comparison of radiological features 3.Comparison of cardiac findings on TTE between two groups 4.Functional outcome at 12 WEEKS 5.Cumulative incidence of TIA during follow-up 6.Mortality 7.Serious adverse events 8.Comparison of secondary prevention strategies utilized & efficacy Timepoint: 4 WEEK Follow-up Mode: In-person clinic visit or telephone contact Interval clinical events Medication adherence & side effects Repeat NIHSS & mRS Complications related to prior investigation 12 WEEK Follow-up In-person clinic visit or comprehensive telephone interview Recurrent stroke Date of recurrence,Vascular territory involvement,NIHSS score at recurrence,Imaging findings Modified Rankin Scale score Functional status assessment | — |
Countries
India
Contacts
Public ContactDr Tushar Patil
Datta Meghe Institute Of Higher Education And Research
Outcome results
None listed