Trial to Evaluate the Ability of a Single Infusion of High-Density Lipoprotein (HDL) to Modulate Markers of Cerebral Ischaemia (REVEAL)

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. Identifier: NCT00822302
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : June 9, 2015
Information provided by (Responsible Party):
St George's, University of London

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Reconstituted High Density Lipoprotein Drug: Saline Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Does recHDL Given i.v. Before CEA Prevent Cerebral Ischaemia? - the Reveal Study.
Study Start Date : February 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Placebo Comparator: 1.Saline Infusion
Patients randomised to this arm will receive an infusion of saline
Drug: 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.
Other Names:
  • rHDL
  • discoidal HDL

Primary Outcome Measures :
  1. Inflammatory and thrombotic response [ Time Frame: baseline, 24 hours after infusion, 48 hours after infusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients listed for elective carotid endarterectomy

Exclusion Criteria:

  • pregnant women and women of childbearing age
  • patient with impaired renal function or liver function
  • patients sectioned under the Mental Health Act

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 identifier (NCT number): NCT00822302

United Kingdom
St Georges University of London
London, Tooting, United Kingdom, SW17 0QT
Sponsors and Collaborators
St George's, University of London

Responsible Party: St George's, University of London Identifier: NCT00822302     History of Changes
Other Study ID Numbers: Eudract Nos: 2008-000093-21
DTX/DDX number:MF8000/13329
Protocol Nos: 04.0008
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: January 2009

Keywords provided by St George's, University of London:

Additional relevant MeSH terms:
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction