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 |
| Protocol serial number | 6979; G0701720 |
| Sponsor | Papworth Hospital NHS Foundation Trust (UK) |
| Funder | Medical Research Council (MRC) (UK) (ref: 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
Scientific
Addenbrooke's Hospital
Wellcome Trust MRC Building
Cambridge
CB2 0XY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Investigation of the effect of glucagon-like-peptide-1 (GLP-1) on left ventricular function during elective coronary angioplasty and stenting |
| Study objectives | Assessment 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) studied | 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 / device / biological / vaccine name(s) | Glucagon-like-peptide-1 |
| Primary outcome measure(s) |
Left ventricular function with and without GLP-1, measured during two balloon inflations in the coronary artery which are 30 minutes apart |
| Key secondary outcome measure(s) |
1. Collateral flow with and without GLP-1 |
| Completion date | 01/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/05/2009 |
| Date of final enrolment | 01/05/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 0XY
United Kingdom
CB2 0XY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/01/2016: Publication reference added.
