Myocardial Infarction Clinical Trial
— GOLD-PCIOfficial title:
A Study to Investigate the Protective Effects of Glucagon-like Peptide-1 (GLP-1) in Patients Undergoing Elective Angioplasty and Stenting (GOLD-PCI)
Verified date | June 2018 |
Source | Papworth Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 193 |
Est. completion date | July 2021 |
Est. primary completion date | March 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Papworth Hospital | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Papworth Hospital NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Plasma Creatine Kinase - Myocardial Bound (CKMB) level | CKMB level on blood test at 6 hours following angioplasty or stenting | 6 hours | |
Secondary | Myocardial Flow Grade after Angioplasty or Stenting | Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale | Measured during procedure | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Ischaemic symptoms during balloon occlusion | Presence or absence or of symptoms of myocardial ischaemia during the procedure | Assessed during procedure | |
Secondary | Myocardial Blush Grade following angioplasty or stenting | Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale | Measured during procedure | |
Secondary | Electrocardiographic (ECG) Changes during procedure | Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure | Assessed during procedure |
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