This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
St George's, University of London Identifier:
First received: January 13, 2009
Last updated: June 5, 2015
Last verified: January 2009

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 Intervention
Stroke Drug: Reconstituted High Density Lipoprotein Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

Further study details as provided by St George's, University of London:

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

Enrollment: 40
Study Start Date: February 2006
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00822302

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

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
Study First Received: January 13, 2009
Last Updated: June 5, 2015

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
Stroke processed this record on July 19, 2017