Condition category
Circulatory System
Date applied
23/04/2002
Date assigned
23/04/2002
Last edited
07/06/2011
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

Mr Massimo Caputo

ORCID ID

Contact details

Bristol Heart Institute
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 9283145
massimocaputo@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PG/02/044/13713

Study information

Scientific title

Acronym

Study hypothesis

A comparison between two diferent strategies of myocardial protection.

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

Ischaemic heart disease

Intervention

Patients will be randomised to:
1. 5 mmol/l Magnesium (Mg2+)
2. 16 mmol/l Mg2+)
In the intermittent antegrade warm blood cardioplegia

Intervention type

Drug

Phase

Not Specified

Drug names

Magnesium

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2001

Overall trial end date

01/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis of ischaemic heart disease
2. Undergoing primary myocardial revascularisation with the use of cardiopulmonary bypass and cardioplegic arrest

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

400 adult patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2001

Recruitment end date

01/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Heart Institute
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

British Heart Foundation (UK)

Sponsor details

14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
+44 (0)20 7935 0185
research@bhf.org.uk

Sponsor type

Charity

Website

http://www.bhf.org.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21353585

Publication citations

  1. Results

    Caputo M, Santo KC, Angelini GD, Fino C, Agostini M, Grossi C, Suleiman MS, Reeves BC, Warm-blood cardioplegia with low or high magnesium for coronary bypass surgery: a randomised controlled trial., Eur J Cardiothorac Surg, 2011, 40, 3, 722-729, doi: 10.1016/j.ejcts.2010.09.049.

Additional files

Editorial Notes