Reperfusion Therapy in Acute Ischemic Stroke With Unclear Onset

NCT01138059 | Completed DMC

• 1 other identifier: AMC-2004-217
• Study Type: observational
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test the hypothesis whether patients with unclear-onset stroke (UnCLOS) treated with thrombolysis could achieve a prespecified rate of good clinical outcome. The secondary hypothesis is that the efficacy outcomes in UnCLOS group would be superior to those in historical UnCLOS group from prospective stroke registries.

Conditions

Stroke

Keywords

Acute ischemic stroke with unclear onset time

Outcome Measures

Primary Outcomes (2)

• Good clinical outcome defined as modified Rankin Scale 0-2

  3 months after treatment

• Symptomatic intracranial hemorrhage

  48 hours after treatment

Study Arms (1)

Acute ischemic stroke patients with unclear onset

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with acute ischemic stroke visiting the ER within 6 hours of the detection of stroke symptoms will be screened for this study.

You may qualify if:

• The patient is male or female and age between 18 and 85 years
• The patient has unclear onset stroke
• Treatment of the patient can be initiated within 6 hours after first found abnormal time
• The patient has imaging-defined penumbra (at least 20%), measured by diffusion- and perfusion-weighted MRI

You may not qualify if:

• The patient has minor neurologic deficits (NIHSS \<4, except aphasia or hemianopia).
• The patient has rapidly resolving neurological symptoms and the rate of improvement is projected to give the patient an NIHSS score \<4 at the time of treatment.
• The patient has a pre-stroke mRS score of \>1 (indicating previous disability).
• The symptoms of stroke are suggestive of subarachnoid hemorrhage.
• Evidence of infective endocarditis or septic embolism
• The patient has a history or clinical presentation of ICH, SAH, or AVM.
• Serious head trauma within 6 weeks
• Prior ischemic stroke in previous 6 weeks (except small infarct)
• Myocardial infarction in the previous 3 weeks
• Gastrointestinal or urinary tract bleeding in previous 21 days
• Major surgery in the previous 14 days
• History of biopsy of a parenchymal organ, trauma with internal organ injury or lumbar puncture within 14 days
• Arterial puncture at a non-compressible site in the previous 7 days
• Uncontrolled high blood pressure (systolic \> 185 mmHg or diastolic \> 110 mmHg on 3 separate occasions at least 10 min apart despite appropriate treatment)
• Evidence of active bleeding or acute trauma (fracture) on examination

Sponsors & Collaborators

• Asan Medical Center: lead
• Ministry of Health & Welfare, Korea: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dong-Wha Kang, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Study Start: October 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 7, 2010

Record last verified: 2006-10