GLP-1 Loading During Elective Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
Angina is caused by narrowings or blockages within coronary arteries. Coronary angioplasty and stenting is performed for people with angina to improve the blood supply to the heart by placing metal tubes within the artery using balloon inflation. The procedure risks small but significant damage to the heart muscle downstream of the balloon. Glucagon like peptide 1 (GLP 1) is a naturally occurring hormone secreted by cells in the gut in response to food. It acts by stimulating the release of insulin. In the heart it acts to increase glucose uptake into cardiac muscle. GLP-1 can protect the heart and improve heart muscle performance in people with coronary artery disease in physiological studies. This study which assesses whether GLP-1 protects the heart during coronary angioplasty and stenting. The hypothesis is that GLP-1 given during elective coronary angioplasty and stenting will reduce cardiac troponin rise (a measure of heart muscle damage) compared to placebo.

Official Title
-----------------
A Study to Investigate the Protective Effects of Glucagon-like Peptide-1 (GLP-1) in Patients Undergoing Elective Angioplasty and Stenting (GOLD-PCI)

Conditions
-----------------
Angina Pectoris, Myocardial Infarction, Reperfusion Injury, Coronary Heart Disease

Intervention / Treatment
-----------------
* Drug: GLP-1
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Undergoing elective PCI Age over 18 Able to give informed consent Exclusion criteria: Severe co-morbidity (expected life expectancy < 6 months) Nicorandil, glibenclamide, sitagliptin, vildagliptin, saxagliptin, linagliptin, liraglutide, exenatide and insulin use Women of child bearing age Breast-feeding women Myocardial infarction within the previous 3 months Baseline elevation of Troponin I before PCI Chronic Renal Impairment (serum creatinine > 160 μmol/l)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Saline<br>Infusion of Normal Saline during Percutaneous Coronary Intervention | Drug: placebo<br>* Normal saline<br>|
| Experimental: GLP-1<br>Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention | Drug: GLP-1<br>* GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min<br>* Other names: GLP-1 (7-36) amide;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Troponin I level | Incidence of Troponin I elevation of > 5 x 99th percentile upper reference limit on blood test at approximately 6 hours post procedure. | 6 Hours following angioplasty or stenting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates | MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases. | From date of randomisation until the date of first event assessed up to 6 months | 
| Plasma Creatine Kinase - Myocardial Bound (CKMB) level | CKMB level on blood test at 6 hours following angioplasty or stenting | 6 hours | 
| Myocardial Flow Grade after Angioplasty or Stenting | Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale | Measured during procedure | 
| MACCE Rates | MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases. | From date of randomisation until the date of first event assessed up to 12 months | 
| MACCE Rates | MACCE rate (death, stent thrombosis, myocardial infarction, acute coronary syndrome, hospitalisation with heart failure, stroke)- these will be patient reported and confirmed by interrogation of hospital records and interrogation of local and national databases. | From date of randomisation until the date of first event assessed up to 60 months | 
| Ischaemic symptoms during balloon occlusion | Presence or absence or of symptoms of myocardial ischaemia during the procedure | Assessed during procedure | 
| Myocardial Blush Grade following angioplasty or stenting | Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale | Measured during procedure | 
| Electrocardiographic (ECG) Changes during procedure | Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure | Assessed during procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angina Pectoris, Percutaneous Coronary Intervention, Myocardial Infarction, Glucagon-Like Peptide 1, Reperfusion Injury