Effect of glucagon-like-peptide-1 (GLP-1) on left ventricular function during percutaneous coronary intervention (PCI)

ISRCTN ISRCTN77442023
DOI https://doi.org/10.1186/ISRCTN77442023
Secondary identifying numbers 6979; G0701720
Submission date
23/04/2010
Registration date
23/04/2010
Last edited
27/01/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Phil Read
Scientific

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

Study information

Study designRandomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleInvestigation of the effect of glucagon-like-peptide-1 (GLP-1) on left ventricular function during elective coronary angioplasty and stenting
Study objectivesAssessment of the cardioprotective effects of glucagon-like-peptide-1 (GLP-1) from ischaemia during coronary angioplasty.
Ethics approval(s)Hertfordshire Research Ethics Committee, 24/04/2009, ref: 09/H0311/17
Health condition(s) or problem(s) studiedTopic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
InterventionAssessment 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Glucagon-like-peptide-1
Primary outcome measureLeft ventricular function with and without GLP-1, measured during two balloon inflations in the coronary artery which are 30 minutes apart
Secondary outcome measures1. 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 study start date22/05/2009
Completion date01/05/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 40
Key inclusion criteria1. 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
Key exclusion criteria1. Atrial fibrillation
2. Myocardial infarction less than 3 months previously
3. Previous coronary artery bypass grafts
4. Treatment with insulin, sitagliptin, vildagliptin or exenatide
Date of first enrolment22/05/2009
Date of final enrolment01/05/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Addenbrooke's Hospital
Cambridge
CB2 0XY
United Kingdom

Sponsor information

Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom

Website http://www.papworthhospital.nhs.uk/index.php
ROR logo "ROR" https://ror.org/01qbebb31

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0701720)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article pilot study results 01/06/2011 Yes No
Results article results 01/02/2015 Yes No

Editorial Notes

27/01/2016: Publication reference added.