GLP-1 Loading During Elective Percutaneous Coronary Intervention

Myocardial Infarction Clinical Trial

— GOLD-PCI  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02127996
• Other study ID #: P01799
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: July 2021

Study information

• Verified date: June 2018
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Reperfusion Injury

Intervention

Drug:
• GLP-1
GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min
• placebo
Normal saline

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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