GOLD-PCI: GLP-1 Loading During Elective Percutaneous Coronary Intervention

Sponsor

Papworth Hospital NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT02127996

Collaborator

(none)

193

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Angina Pectoris Myocardial Infarction Reperfusion Injury Coronary Heart Disease	Drug: GLP-1 Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

193 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Mar 31, 2017

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Normal Saline Infusion of Normal Saline during Percutaneous Coronary Intervention	Drug: placebo Normal saline
Experimental: GLP-1 Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention	Drug: GLP-1 GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min Other Names: GLP-1 (7-36) amide

Arm

Intervention/Treatment

Placebo Comparator: Normal Saline

Infusion of Normal Saline during Percutaneous Coronary Intervention

Drug: placebo

Normal saline

Experimental: GLP-1

Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention

Drug: GLP-1

GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min

Other Names:

GLP-1 (7-36) amide

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
Myocardial Flow Grade after Angioplasty or Stenting [Measured during procedure]
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
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.
MACCE Rates [From date of randomisation until the date of first event assessed up to 60 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.
Ischaemic symptoms during balloon occlusion [Assessed during procedure]
Presence or absence or of symptoms of myocardial ischaemia during the procedure
Myocardial Blush Grade following angioplasty or stenting [Measured during procedure]
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Electrocardiographic (ECG) Changes during procedure [Assessed during procedure]
Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)