Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT03210051
Eligibility Criteria:
Inclusion Criteria:
1. Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
2. No remarkable pre-stroke functional disability (mRS ≤ 1);
3. Age ≥18 and ≤ 80;
4. Patient treatable within six hours of symptom onset;
5. Informed consent obtained from patient or acceptable patient's surrogate
Exclusion Criteria:
1. Identified hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0;
2. Baseline platelet count \< 30\*109/L;
3. Baseline blood glucose of \< 2.7mmol/L or \>22.2mmol/L;
4. Renal insufficiency with creatinine ≥ 265 umol/L;
5. Severe, sustained hypertension (SBP \> 185 mmHg or DBP \> 110 mmHg);
6. Woman of childbearing potential who is known to be pregnant or lactating;
7. Subject participating in a study involving other drug or device trial study;
8. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations;
9. Unlikely to be available for 90-day follow-up;
10. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs;
11. Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of \<7 on noncontrast CT;
12. CT or MRI evidence of hemorrhage;
13. Significant mass effect with midline shift on CT or MRI scans;
14. Subjects with artery occlusions in multiple vascular territories;
15. Evidence of intracranial tumor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03210051
Study Brief:
Protocol Section:
NCT03210051