Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227448
Status:
COMPLETED
Last Update Posted:
2008-04-03
First Post:
2005-09-26
Brief Title:
Induced Hypertension for Acute Ischemic Stroke
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Induced Hypertension for Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The ultimate goal of this multicenter phase II study is to increase blood pressure until either a neurologic response is seen or a target mean arterial pressure of 30 above baseline is achieved IV fluids IV phenylephrine andor IV norepinephrine are used to rapidly raise mean arterial pressure in a controlled manner as serial assessments of neurologic function are performed
Detailed Description:
This is a multicenter pilot clinical trial The primary outcome variables will be the presence or absence of improvement in NIHSS during treatment with induced hypertension and the number of adverse events The secondary outcome variables will be final infarct size on MRI at 1 month and Barthel Index and Modified Rankin Scale at 3 months
All patients fulfilling the inclusion and exclusion criteria and who are willing to participate will receive intervention to induce hypertension including intravenous saline phenylephrine neosynephrine or levophed and possibly oral midodrine Blood pressure will be increased to a maximum mean arterial pressure MAP that is 30 above the baseline MAP as measured in the emergency department The acute phase of the study will last for 3-5 days for responders and all patients will be followed up at 1 and 3 months post stroke onset All patients will undergo neurologic cognitive and physical examinations as well as serial MRI studies with diffusion and perfusion-weighted imaging
Primary hypotheses will be measured using the National Institutes of Health Stroke Scale NIHSS and MRI Improvement following induced hypertension will be measured by comparing NIHSS performed at multiple time points throughout the study The ability to predict diffusion-perfusion mismatch will be determined by comparing MRI 1 and MRI 2 NIHSS and MRI will also be compared to determine if NIHSS correlates with reperfusion area on MRI
The secondary hypothesis of improved long-term outcome will be measured using the Barthel Index the modified Rankin Scale and MRIFlair at 1 and 3 months post stroke symptom onset
All patients fulfilling the inclusion and exclusion criteria and who are willing to participate will receive intervention to induce hypertension including intravenous saline phenylephrine neosynephrine or levophed and possibly oral midodrine Blood pressure will be increased to a maximum mean arterial pressure MAP that is 30 above the baseline MAP as measured in the emergency department The acute phase of the study will last for 3-5 days for responders and all patients will be followed up at 1 and 3 months post stroke onset All patients will undergo neurologic cognitive and physical examinations as well as serial MRI studies with diffusion and perfusion-weighted imaging
Primary hypotheses will be measured using the National Institutes of Health Stroke Scale NIHSS and MRI Improvement following induced hypertension will be measured by comparing NIHSS performed at multiple time points throughout the study The ability to predict diffusion-perfusion mismatch will be determined by comparing MRI 1 and MRI 2 NIHSS and MRI will also be compared to determine if NIHSS correlates with reperfusion area on MRI
The secondary hypothesis of improved long-term outcome will be measured using the Barthel Index the modified Rankin Scale and MRIFlair at 1 and 3 months post stroke symptom onset
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS042607 | NIH | None | httpsreporternihgovquickSearchR01NS042607 |