Angina Pectoris, Coronary Heart Disease, Myocardial Infarction, Reperfusion Injury
Conditions
Keywords
Angina Pectoris, Percutaneous Coronary Intervention, Myocardial Infarction, Glucagon-Like Peptide 1, Reperfusion Injury
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.
Interventions
DRUGGLP-1
GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min
DRUGplacebo
Normal saline
Sponsors
Papworth Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Troponin I level | 6 Hours following angioplasty or stenting | Incidence of Troponin I elevation of \> 5 x 99th percentile upper reference limit on blood test at approximately 6 hours post procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Blush Grade following angioplasty or stenting | Measured during procedure | Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale |
| Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates | From date of randomisation until the date of first event assessed up to 6 months | 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. |
| Plasma Creatine Kinase - Myocardial Bound (CKMB) level | 6 hours | CKMB level on blood test at 6 hours following angioplasty or stenting |
| Ischaemic symptoms during balloon occlusion | Assessed during procedure | Presence or absence or of symptoms of myocardial ischaemia during the procedure |
| MACCE Rates | From date of randomisation until the date of first event assessed up to 12 months | 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. |
| Electrocardiographic (ECG) Changes during procedure | Assessed during procedure | Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure |
| Myocardial Flow Grade after Angioplasty or Stenting | Measured during procedure | Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale |
Countries
United Kingdom
Outcome results
None listed