CRISTINA: Clinical Research of Intravenous Thrombolysis for Ischemic Stroke in Northeast of China

Sponsor

Yi Yang (Other)

Overall Status

Recruiting

CT.gov ID

NCT05028868

Collaborator

(none)

500

Enrollment

Location

127.9

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research is based on clinic treatment of intravenous thrombolysis for patients with acute ischemic stroke.By building up a database of these patients, the investigators aim to find some significance between groups by analyzing population information, clinical status and such for better evaluation and optimal treatment decision.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Thrombosis

Detailed Description

With the highest incidence rate,the population in northeast of China is severely tormented by stroke, especially ischemic stroke. The investigators lunch this project by building up a database of detailed information of patients that fits the criteria of intravenous thrombolysis therapy.Including biochemical markers,imaging and follow-up,investigators intend to analysis these data,find factors that contributes to better prognosis,so as to push forward the prevention and control work.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Research of Intravenous Thrombolysis for Ischemic Stroke in Northeast of China

Actual Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Feb 28, 2025

Anticipated Study Completion Date :

Jan 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
Large artery atherosclerosis(LAA)
Cardiogenic stroke(CS)
Penetrating artery disease(PAD)
Other etiology(OE)
undetermined etiology(UE)

Outcome Measures

Primary Outcome Measures

mRS score in 90 days [90 days]
Using mRS score to evaluate the effective of thrombolysis among different groups.
Stroke recurrence within 90 days [90 days]
Newly onset stroke that the time interval was less than 90 days from the original stroke event was considered as stroke recurrence. Ischemic stroke was defined as acute focal brain or retinal infarction.

Secondary Outcome Measures

Cardiovascular death in 1 year [1 year]
Death direct from ischemic stroke, hemorrhagic stroke, sudden cardiac death, acute myocardial infarction, heart failure, and other cardiovascular death including cardiac arrhythmia that unrelated to sudden cardiac death, pulmonary embolism, cardiovascular intervention (unrelated to acute MI), ruptured aortic aneurysm, or peripheral arterial disease).
Post-stroke disability in 1 year [1 year]
modified Rankin Scale(mRS)≥3

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of ischemic stroke causing measurable neurological deficit
Onset of symptoms <4.5 h before treatment begins
Age ≥18 y

Exclusion Criteria:

Significant head trauma or prior stroke in the previous 3 mo
Symptoms suggest SAH
Arterial puncture at noncompressible site in previous 7 d
History of previous intracranial hemorrhage
Intracranial neoplasm, AVM, or aneurysm
Recent intracranial or intraspinal surgery
Elevated blood pressure (systolic >185 mm Hg or diastolic >110 mm Hg)
Active internal bleeding
Acute bleeding diathesis, including but not limited to
Platelet count <100 000/mm3
Heparin received within 48 h resulting in abnormally elevated aPTT above the upper limit of normal
Current use of anticoagulant with INR >1.7 or PT >15 s
Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
Blood glucose concentration <50 mg/dL (2.7 mmol/L)
CT demonstrates multilobar infarction (hypodensity >1/3 cerebral hemisphere)
Relative exclusion criteria
Recent experience suggests that under some circumstances, with careful consideration and weighting of risk to benefit, patients may receive fibrinolytic therapy despite ≥1 relative contraindications. Consider risk to benefit of intravenous rtPA administration carefully if any of these relative contraindications is present
Only minor or rapidly improving stroke symptoms (clearing spontaneously)
Pregnancy
Seizure at onset with postictal residual neurological impairments
Major surgery or serious trauma within previous 14 d
Recent gastrointestinal or urinary tract hemorrhage (within previous 21 d)
Recent acute myocardial infarction (within previous 3 mo)