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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
193
Papworth Hospital
Cambridge, Cambridgeshire, United Kingdom
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.
Time frame: 6 Hours following angioplasty or stenting
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.
Time frame: 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
Time frame: 6 hours
Myocardial Flow Grade after Angioplasty or Stenting
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Assessed during procedure
Myocardial Blush Grade following angioplasty or stenting
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Time frame: Measured during procedure
Electrocardiographic (ECG) Changes during procedure
Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure
Time frame: Assessed during procedure
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