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

St George's, University of London

Status: Completed

Conditions: Stroke

Treatments: Drug: Saline; Drug: Reconstituted High Density Lipoprotein

Study type: Interventional

Funder types: Other

Identifiers

NCT00822302

Protocol Nos: 04.0008

DTX/DDX number:MF8000/13329

Eudract Nos: 2008-000093-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

1.Saline Infusion

Placebo Comparator group

Description:

Patients randomised to this arm will receive an infusion of saline

Treatment:

Drug: Saline

2.recHDL

Active Comparator group

Description:

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.

Treatment:

Drug: Reconstituted High Density Lipoprotein