Clinical trial NCT02127996: GLP-1 Loading During Elective Percutaneous Coronary Intervention
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Angina Pectoris
Myocardial Infarction
Reperfusion Injury
Coronary Heart Disease
Keywords: Angina Pectoris
Percutaneous Coronary Intervention
Myocardial Infarction
Glucagon-Like Peptide 1
Reperfusion Injury
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2014-05-01
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Plasma Troponin I level
timeFrame: 6 Hours following angioplasty or stenting
Secondary outcomes:
measure: Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates
timeFrame: From date of randomisation until the date of first event assessed up to 6 months
measure: Plasma Creatine Kinase - Myocardial Bound (CKMB) level
timeFrame: 6 hours
measure: Myocardial Flow Grade after Angioplasty or Stenting
timeFrame: Measured during procedure
measure: MACCE Rates
timeFrame: From date of randomisation until the date of first event assessed up to 12 months
measure: MACCE Rates
timeFrame: From date of randomisation until the date of first event assessed up to 60 months
measure: Ischaemic symptoms during balloon occlusion
timeFrame: Assessed during procedure
measure: Myocardial Blush Grade following angioplasty or stenting
timeFrame: Measured during procedure
measure: Electrocardiographic (ECG) Changes during procedure
timeFrame: Assessed during procedure
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
state: Cambridgeshire
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Stephen Hoole, MA MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giblett JP, Clarke S, Zhao T, McCormick LM, Braganza DM, Densem CG, O'Sullivan M, Adlam D, Clarke SC, Steele J, Fielding S, West NEJ, Villar SS, Hoole SP. The role of Glucagon-Like Peptide 1 Loading on periprocedural myocardial infarction During elective PCI (GOLD-PCI study): A randomized, placebo-controlled trial. Am Heart J. 2019 Sep;215:41-51. doi: 10.1016/j.ahj.2019.05.013. Epub 2019 Jun 9.