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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Georges University of London

London, Tooting, SW17 0QT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reconstituted High Density Lipoprotein

Drug

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

Saline

Drug

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 names: normal saline

Primary outcomes

Inflammatory and thrombotic response

Time frame: baseline, 24 hours after infusion, 48 hours after infusion

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Registry information

Official study title

Does recHDL Given i.v. Before CEA Prevent Cerebral Ischaemia? - the Reveal Study.

Acronym: REVEAL

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2009
First posted: Jan 14, 2009
Registry last updated: Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed