GLP-1 Loading During Elective Percutaneous Coronary Intervention (GOLD-PCI)
Primary Purpose
Angina Pectoris, Myocardial Infarction, Reperfusion Injury
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
GLP-1
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Angina Pectoris focused on measuring Angina Pectoris, Percutaneous Coronary Intervention, Myocardial Infarction, Glucagon-Like Peptide 1, Reperfusion Injury
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)
Sites / Locations
- Papworth Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Normal Saline
GLP-1
Arm Description
Infusion of Normal Saline during Percutaneous Coronary Intervention
Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Plasma Creatine Kinase - Myocardial Bound (CKMB) level
CKMB level on blood test at 6 hours following angioplasty or stenting
Myocardial Flow Grade after Angioplasty or Stenting
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
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.
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.
Ischaemic symptoms during balloon occlusion
Presence or absence or of symptoms of myocardial ischaemia during the procedure
Myocardial Blush Grade following angioplasty or stenting
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Electrocardiographic (ECG) Changes during procedure
Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure
Full Information
NCT ID
NCT02127996
First Posted
April 24, 2014
Last Updated
June 5, 2018
Sponsor
Papworth Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02127996
Brief Title
GLP-1 Loading During Elective Percutaneous Coronary Intervention
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Papworth Hospital NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Myocardial Infarction, Reperfusion Injury, Coronary Heart Disease
Keywords
Angina Pectoris, Percutaneous Coronary Intervention, Myocardial Infarction, Glucagon-Like Peptide 1, Reperfusion Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Infusion of Normal Saline during Percutaneous Coronary Intervention
Arm Title
GLP-1
Arm Type
Experimental
Arm Description
Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention
Intervention Type
Drug
Intervention Name(s)
GLP-1
Other Intervention Name(s)
GLP-1 (7-36) amide
Intervention Description
GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
Plasma Troponin I level
Description
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
Secondary Outcome Measure Information:
Title
Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates
Description
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
Title
Plasma Creatine Kinase - Myocardial Bound (CKMB) level
Description
CKMB level on blood test at 6 hours following angioplasty or stenting
Time Frame
6 hours
Title
Myocardial Flow Grade after Angioplasty or Stenting
Description
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Time Frame
Measured during procedure
Title
MACCE Rates
Description
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
Title
MACCE Rates
Description
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
Title
Ischaemic symptoms during balloon occlusion
Description
Presence or absence or of symptoms of myocardial ischaemia during the procedure
Time Frame
Assessed during procedure
Title
Myocardial Blush Grade following angioplasty or stenting
Description
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Time Frame
Measured during procedure
Title
Electrocardiographic (ECG) Changes during procedure
Description
Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure
Time Frame
Assessed during procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Hoole, MA MD FRCP
Organizational Affiliation
Papworth Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Papworth Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31277053
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.
Results Reference
derived
Learn more about this trial
GLP-1 Loading During Elective Percutaneous Coronary Intervention
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