Trial to Evaluate the Ability of a Single Infusion of High-Density Lipoprotein (HDL) to Modulate Markers of Cerebral Ischaemia (REVEAL)
Recruitment status was Active, not recruiting
The plasma concentration of high-density lipoprotein (HDL) can have anti-inflammatory, anti-oxidative and anti-thrombotic effects in addition to being able to remove cholesterol from peripheral tissues for secretion via the liver.
The investigators hypothesise that elevation of plasma HDLs will reduce the inflammatory response following removal of unstable atherosclerotic plaques in the carotid artery. Such plaques can cause strokes and there is great benefit from early surgical removal, however such surgical procedures involve significant risks to the patient.
The investigators propose infusing HDL into patients prior to removal of their unstable carotid plaque and measuring the changes in inflammatory responses in comparison to a similar placebo controlled group of patients.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Does recHDL Given i.v. Before CEA Prevent Cerebral Ischaemia? - the Reveal Study.|
- Inflammatory and thrombotic response [ Time Frame: baseline, 24 hours after infusion, 48 hours after infusion ] [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Estimated Study Completion Date:||February 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1.Saline Infusion
Patients randomised to this arm will receive an infusion of saline
Saline (0.9%) is provided as a sterile infusion bag and infused over a period of 4 hours, 24 hours prior to carotid endarterectomy
Other Name: normal saline
Active Comparator: 2.recHDL
Patients randomised to the active comparator arm of the study will receive 40mg/kg reconstituted High density lipoproteins (lot nos 05422-00006) over a period of 4 hours, 24 hours prior to carotid endarterectomy.
Drug: Reconstituted High Density Lipoprotein
RecHDL (Lot Nos 05422-00006)is provided as a lyophilised powder and reconstituted with sterile water at 25 mg/ml. The infusion is made at 40 mg/kg over a period of 4 hours.
Following written informed consent, patients will be randomised to either the placebo or active arm of the study. Bloods will be taken for baseline measurements, and the infusion of either saline (placebo) or rHDL (active agent) will be carried out on the ward. Infusion will take 4 hours, and the active agent infused at 40mg/kg.
Just prior to CAE, bloods will be collected (24 hours post-infusion) and the atherosclerotic tissue collected into RNA stabilising agent for subsequent analysis. Further bloods will then be collected 24 hours post-operatively (48 hours post-infusion).
Patients vital signs will be monitored hourly following infusion and will be reviewed in out-patients at 6 weeks after the operation.