Condition category
Circulatory System
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
27/01/2016
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 Phil Read

ORCID ID

Contact details

Addenbrooke's Hospital
Wellcome Trust MRC Building
Cambridge
CB2 0XY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6979; G0701720

Study information

Scientific title

Investigation of the effect of glucagon-like-peptide-1 (GLP-1) on left ventricular function during elective coronary angioplasty and stenting

Acronym

Study hypothesis

Assessment of the cardioprotective effects of glucagon-like-peptide-1 (GLP-1) from ischaemia during coronary angioplasty.

Ethics approval

Hertfordshire Research Ethics Committee, 24/04/2009, ref: 09/H0311/17

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

Assessment of left ventricular function during coronary angioplasty. In the active arm patients will receive an intravenous infusion of glucagon-like peptide-1 at 1.2 pmol/kg/min which will start after the 1st balloon inflation in the coronary artery and will run until the end of the procedure. In the control arm there will be no infusion.

Intervention type

Drug

Phase

Not Applicable

Drug names

Glucagon-like-peptide-1

Primary outcome measures

Left ventricular function with and without GLP-1, measured during two balloon inflations in the coronary artery which are 30 minutes apart

Secondary outcome measures

1. Collateral flow with and without GLP-1
2. Troponin I at 24 hours

Measured during two balloon inflations in the coronary artery which are 30 minutes apart.

Overall trial start date

22/05/2009

Overall trial end date

01/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age over 18 (male or female and no upper age limit)
2. Able to give informed consent
3. On the waiting list for elective PCI to a single vessel coronary stenosis
4. Normal left ventricular function

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40

Participant exclusion criteria

1. Atrial fibrillation
2. Myocardial infarction less than 3 months previously
3. Previous coronary artery bypass grafts
4. Treatment with insulin, sitagliptin, vildagliptin or exenatide

Recruitment start date

22/05/2009

Recruitment end date

01/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 0XY
United Kingdom

Sponsor information

Organisation

Papworth Hospital NHS Foundation Trust (UK)

Sponsor details

Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Sponsor type

Government

Website

http://www.papworthhospital.nhs.uk/index.php

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0701720)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/21586690
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25700752

Publication citations

  1. Pilot study results

    Read PA, Hoole SP, White PA, Khan FZ, O'Sullivan M, West NE, Dutka DP, A pilot study to assess whether glucagon-like peptide-1 protects the heart from ischemic dysfunction and attenuates stunning after coronary balloon occlusion in humans., Circ Cardiovasc Interv, 2011, 4, 3, 266-272, doi: 10.1161/CIRCINTERVENTIONS.110.960476.

  2. Results

    McCormick LM, Hoole SP, White PA, Read PA, Axell RG, Clarke SJ, O'Sullivan M, West NE, Dutka DP, Pre-treatment with glucagon-like Peptide-1 protects against ischemic left ventricular dysfunction and stunning without a detected difference in myocardial substrate utilization, JACC Cardiovasc Interv, 2015 , 8, 2, 292-301, doi: 10.1016/j.jcin.2014.09.014.

Additional files

Editorial Notes

27/01/2016: Publication reference added.