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
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: G0701720)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
-
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.
-
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.