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Phase 1 N=57 Triple-blind Diagnostic

The Capillary Index Score Trial

Acute Stroke · Brain Ischemia · Ischemic Stroke

Bottom Line

View on ClinicalTrials.gov: NCT02618031 ↗
Enrolled (actual)
57
Serious AEs
1.8%
Results posted
Feb 2020
Primary outcome: Primary: Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group. — 22; 1; 23; 10 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Endovascular Treatment (EVT) (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Firas Al-Ali
Primary completion
Aug 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.		 22; 1; 23; 10 —
SECONDARY
Complication Rate Between Favorable CIS Group Versus Poor CIS Group		 1; 4; 44; 6 —
SECONDARY
Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.		 19; 1; 3; 0; 17; 7 —

Summary

This study seeks to investigate the capillary index score (CIS) to further improve patient selection of endovascular treatment (EVT) in acute ischemic stroke (AIS). The hypothesis or idea being tested: Patients with favorable CIS who are successfully revascularized with EVT can have successful outcomes with an extended time window for treatment.

Eligibility Criteria

Inclusion Criteria

  • Anterior circulation acute ischemic stroke due to blockage of the intracranial internal carotid artery or middle cerebral artery (M1)
  • Within 24 hours of onset of symptoms
  • NIHSS Score is 8 or greater

Exclusion Criteria

  • Contra-indication for IAT found on initial CT
  • Intracranial hemorrhage
  • Stroke mimics (tumor, herpetic encephalitis, etc.)
  • More than 1/3 hypodensity on non-enhanced head CT prior to intervention
  • ASPECT Score less than 6
  • Pre-existing disability defined as modified Rankin Scale (mRS) score more than 2
  • Pregnant women
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02618031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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