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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by St George's, University of London.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00822302
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Does recHDL Given i.v. Before CEA Prevent Cerebral Ischaemia? - the Reveal Study.

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2006
Estimated 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822302

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

No publications provided

Responsible Party: Gillian W Cockerill, St George's University of London
ClinicalTrials.gov 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: January 13, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on April 17, 2014