Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ziad Ali

ORCID ID

Contact details

Department of Vascular Surgery
Box 201
Addenbrooke's Hospital
Long Road
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544122070

Study information

Scientific title

Acronym

Study hypothesis

Patients undergoing major vascular surgery are at significant risk of developing postoperative myocardial complications, particularly myocardial infarction. Protecting the heart during the perioperative period could provide a method to reduce morbidity and mortality after vascular surgery. Ischaemic preconditioning is a well recognised phenomenon, whereby a brief period of ischaemia followed by reperfusion prior to a prolonged ischaemic event can provide protection from cellular injury. Protection can be performed either by a stimulus to the myocardium itself or by ischaemia at a site distant to the heart. The aim of this study is to determine whether remote ischaemic preconditioning confers a reduction in myocardial damage in patients undergoing abdominal aortic aneurysm repair.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Aortic aneurysm repair

Intervention

Randomised controlled trial:
1. Abdominal aortic aneurysm repair alone
2. Abdominal aortic aneurysm repair with intermittent cross clamping/perfusion of common iliac artery
Postoperatively, patients will have cardiac troponin and creatine kinase MB (CKMB) recorded on days 1, 3 and 7. Holter monitoring is to be continued until 48 h post operation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

A reduction in myocardial damage as assessed by serum measurement of cardiac troponin and Holter electrocardiogram.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/01/2003

Overall trial end date

09/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

72 Subjects aged 18-90.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

72

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

10/01/2003

Recruitment end date

09/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Vascular Surgery
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Research council

Funder name

Cambridge Consortium - Addenbrookes (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17846333

Publication citations

  1. Results

    Ali ZA, Callaghan CJ, Lim E, Ali AA, Nouraei SA, Akthar AM, Boyle JR, Varty K, Kharbanda RK, Dutka DP, Gaunt ME, Remote ischemic preconditioning reduces myocardial and renal injury after elective abdominal aortic aneurysm repair: a randomized controlled trial., Circulation, 2007, 116, 11 Suppl, I98-105, doi: 10.1161/circulationaha.106.679167.

Additional files

Editorial Notes