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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05028868
Acronym
CRISTINA
Enrollment
500
Registered
2021-08-31
Start date
2015-06-01
Completion date
2026-01-28
Last updated
2024-03-01

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

Conditions

Ischemic Stroke, Thrombosis

Keywords

ischemic stroke, thrombolysis

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.

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.

Interventions

None listed

Sponsors

Yi Yang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Diagnosis of ischemic stroke causing measurable neurological deficit 2. Onset of symptoms \<4.5 h before treatment begins 3. Age ≥18 y

Exclusion criteria

1. Significant head trauma or prior stroke in the previous 3 mo 2. Symptoms suggest SAH 3. Arterial puncture at noncompressible site in previous 7 d 4. History of previous intracranial hemorrhage 5. Intracranial neoplasm, AVM, or aneurysm 6. Recent intracranial or intraspinal surgery 7. Elevated blood pressure (systolic \>185 mm Hg or diastolic \>110 mm Hg) 8. Active internal bleeding 9. Acute bleeding diathesis, including but not limited to 10. Platelet count \<100 000/mm3 11. Heparin received within 48 h resulting in abnormally elevated aPTT above the upper limit of normal 12. Current use of anticoagulant with INR \>1.7 or PT \>15 s 13. 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) 14. Blood glucose concentration \<50 mg/dL (2.7 mmol/L) 15. CT demonstrates multilobar infarction (hypodensity \>1/3 cerebral hemisphere) 16. Relative

Design outcomes

Primary

MeasureTime frameDescription
mRS score in 90 days90 daysUsing mRS score to evaluate the effective of thrombolysis among different groups.
Stroke recurrence within 90 days90 daysNewly 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

MeasureTime frameDescription
Cardiovascular death in 1 year1 yearDeath 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 year1 yearmodified Rankin Scale(mRS)≥3

Countries

China

Contacts

Primary ContactYi Yang, MD,PhD
doctor_yangyi@hotmail.com
Backup ContactZhenni Guo, MD
zhen1ni2@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026