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TCD Monitoring Technology Guides the Precise Control of Blood Pressure After EVT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529149
Recruitment Status : Unknown
Verified April 2018 by Xuanwu Hospital, Beijing.
Recruitment status was:  Recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Brief Summary:
Investigators hypothesized that the precise regulation of blood pressure based on the changes of cerebral blood flow parameters under TCD monitoring can better improve the state of cerebral blood flow, reduce the risk of early neurological deterioration and improve the prognosis of the patients.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Combination Product: Urapidil Hydrochloride Injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TCD Monitoring Technology Guides the Precise Control of Blood Pressure After EVT
Actual Study Start Date : April 8, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Accurate blood pressure control
Implementing accurate blood pressure management under TCD monitoring
Combination Product: Urapidil Hydrochloride Injection

Accurate monitoring of blood pressure is carried out under TCD monitoring, that is to maintain (mean flow velocity)MFV or (pulse index)PI target blood pressure. The target values of MFV and PI are MFV>37cm/s of (middle cerebral artery)MCA, PI < 1.34cm/s, aMFV>40cm/s of (basilar artery)BA, PI < 0.8cm/s.

TCD shows that when the MFV of MCA or BA is lower than the target value, the blood pressure is reduced or discontinued according to the insufficiency of blood flow. and the current blood pressure is maintained once MFV is met. TCD showed that the PI index of MCA or BA was higher than the target value . The blood pressure reduction was treated by excessive perfusion: intravenous infusion of blood pressure drugs , once PI index is up to the standard, maintaining the current blood pressure.

Other Name: Diltiazem Hydrochloride for Injection

Active Comparator: Guideline blood pressure control
Control blood pressure according to guidelines
Combination Product: Urapidil Hydrochloride Injection

Accurate monitoring of blood pressure is carried out under TCD monitoring, that is to maintain (mean flow velocity)MFV or (pulse index)PI target blood pressure. The target values of MFV and PI are MFV>37cm/s of (middle cerebral artery)MCA, PI < 1.34cm/s, aMFV>40cm/s of (basilar artery)BA, PI < 0.8cm/s.

TCD shows that when the MFV of MCA or BA is lower than the target value, the blood pressure is reduced or discontinued according to the insufficiency of blood flow. and the current blood pressure is maintained once MFV is met. TCD showed that the PI index of MCA or BA was higher than the target value . The blood pressure reduction was treated by excessive perfusion: intravenous infusion of blood pressure drugs , once PI index is up to the standard, maintaining the current blood pressure.

Other Name: Diltiazem Hydrochloride for Injection




Primary Outcome Measures :
  1. early neurological deterioration [ Time Frame: 72 hours ]
    the incidence of 72 hours in National Institute of Health stroke scale increased more than 4 points or National Institute of Health stroke scale Ia score more than 1 points


Secondary Outcome Measures :
  1. prognosis of nerve function [ Time Frame: 3 months ]
    prognosis of nerve function use Modified Rankin Scale,0~3 is good prognosis and 4~6 is poor prognosis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older;
  • accept EVT treatment within 6 hours of symptoms onset;
  • In selected patients with AIS within 6 to 16 hours of last known normal who have LVO in the anterior circulation and meet other DAWN or DEFUSE 3 eligibility criteria..
  • In selected patients with AIS within 6 to 24 hours of last known normal who have LVO in the anterior circulation and meet other DAWN eligibility criteria.

Exclusion Criteria:

  • Pre - onset mRS>2;
  • severe dementia;
  • threatening life diseases (such as malignant tumor, etc.);
  • non acute ischemic cerebrovascular disease patients undergoing selective intravascular treatment;
  • related sound window closure can not be monitoring with TCD.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529149


Locations
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China, Beijing
Xuanwu Hospital Recruiting
Beijing, Beijing, China, 100053
Contact: Su Yingying    15901361953    tangsuyingying@sina.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
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Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03529149    
Other Study ID Numbers: [2018]007
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diltiazem
Urapidil
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents