Status:
COMPLETED
Blood Pressure Control in Acute Ischemic Stroke
Lead Sponsor:
National University of Singapore
Conditions:
Blood Pressure
Acute Stroke
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Management of acutely elevated blood pressure during the early phase of ischemic stroke remains controversial. In patients treated with IV-tPA, the risk of ICH is closely related to the BP levels. How...
Detailed Description
Specific aims- 1. To determine the tolerability of intensive blood pressure (BP) lowering with intravenous Labetalol infusion (assessed by achieving systolic BP 140-160mmHg range within 6hours of sym...
Eligibility Criteria
Inclusion
- Disabling neurological deficit (NIHSS minimum 4 points) due to stroke.
- IV thrombolysis initiated within 4.5 hours of symptom-onset.
- No hemorrhage on baseline non-contrast head CT scan.
- At least two consecutive BP measurements (taken at ≥5 min apart) of 160-185mmHg (systolic) and 90 -105mmHg (diastolic) at the time of randomization (BP \>185/105mmHg would be treated as standard of care in patient treated with IV-TPA).
- Patients between 21-80 years of age, either gender and all ethnicities would be eligible for inclusion. Consent for participation in this study would be obtained from the patient. In patients unable to give consent due to speech or mental disabilities due to stroke, consent would be obtained from the nearest relative.
- Although, men and women of reproducible age would be enrolled, all contraception methods would be allowed once they are physically fit.
Exclusion
- Patients considered ineligible for IV-TPA. Patients treated with mechanical thrombectomy) would not be included.
- Symptomatic occlusion or \>70% stenosis of the internal carotid artery.
- Patients with impaired CVR on TCD. Vasodilatory reserve would be evaluated with the hypercapnoeic challenge (voluntary breath-holding for 30 seconds and monitoring of the mean flow velocities of both MCAs. In patients who are aphasic or unable to hold breath, the hypercapnoeic challenge would consist of subjecting these patients to re-breathe in a closely fit oxygen mask connected with air bag and a capnometer. Our lab has already validated this method against voluntary breath- holding test and acetazolamide challenged SPECT. Patients with an impaired CVR (breath holding index \<0.69) would be excluded from the study since this figure is associated with an increased risk of stroke due to cerebral hypoperfusion.
- Patients with severe intracranial stenosis.
- Conditions requiring urgent antihypertensive treatment independent of BP levels (acute myocardial infarction, severe left ventricular heart failure, aortic dissection, acute renal failure, acute pulmonary oedema and hypertensive encephalopathy)
- Functional dependence prior to the acute stroke quantified as a mRS-score of \>1.
- Contraindications to Labetalol- for example- history of asthma, right-sided congestive heart failure, bradycardia, and heart block.
- Patients with contraindications for CT perfusion (like allergy to contrast, renal impairment- serum creatinine \>176 µmol/L (2 mg/dL) since creatinine above this level is associated with high risk of contrast induced nephropathy. We will exclude patients with estimated GFR \<30ml/minute.
- Diabetic patients with normal renal functions would be included. However, we will stop Metformin (if they are receiving it) for 3 days and monitor renal functions.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2019
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03443596
Start Date
December 1 2014
End Date
March 13 2019
Last Update
April 16 2019
Active Locations (1)
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1
Division of Neurology, National University Hospital
Singapore, Singapore, 119074