Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery (CASPER)

May 19, 2010 updated by: University Hospital Birmingham
Open-heart surgery causes injury of the heart muscle. Although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. During surgery, techniques are used to protect the heart from injury, but these remain imperfect. This study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug Perhexiline given before the operation. This treatment has a sound experimental basis for improving outcome. If this improvement is confirmed surgical results could be improved. The investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. The investigators' hypothesis is that Perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • University Hospital Birmingham
    • West Sussex
      • Brighton, West Sussex, United Kingdom, BN2 5BE
        • Brighton & Sussex University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult
  • First-time
  • Isolated coronary artery bypass surgery

Exclusion Criteria:

  • Diabetes Mellitus
  • Renal impairment with Creatinine greater than or equal to 200micromol/L
  • Atrial fibrillation
  • Amiodarone therapy, recent (in last month) or current
  • Hepatic impairment, significant preoperative
  • Peripheral neuropathy
  • Pregnancy or breast-feeding
  • Emergency surgery or required on clinical grounds within 5 days of referral

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perhexiline
Pre-operative administration of Perhexiline tablets according to dosing schedule
Drug: Perhexiline
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
Other Names:
  • PEXSIG
Placebo Comparator: Placebo
Pre-operative administration of placebo tablets according to dosing schedule
Drug: Placebo marked PEXSIG
Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Low Cardiac Output Syndrome
Time Frame: 6 hours post-removal of aortic X-clamp
6 hours post-removal of aortic X-clamp

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase in Cardiac index of greater than or equal to 0.3 L/min/m2
Time Frame: 6 hours post-removal of aortic X-clamp
6 hours post-removal of aortic X-clamp
Incidence of inotropes use according to protocol
Time Frame: 6 and 12 hours post-removal of aortic X-clamp
6 and 12 hours post-removal of aortic X-clamp
Peak and total release of Troponin
Time Frame: 6, 12 and 24 hours post-release of aortic X-clamp
6, 12 and 24 hours post-release of aortic X-clamp

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham

Collaborators

Brighton and Sussex University Hospitals NHS Trust
British Heart Foundation
University of Birmingham

Investigators

  • Principal Investigator: Domeinco Pagano, MD FRCS, University Hospital Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2010

Last Update Submitted That Met QC Criteria

May 19, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK3217
  • Eudract 2006-003164-62
  • REC 06/Q0104/141
  • BHF PG/06/044/20703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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