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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Placebo Comparator | Infusion of Normal Saline during Percutaneous Coronary Intervention |
|
| GLP-1 | Experimental | Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 | Drug | GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Hoole, MA MD FRCP | Papworth Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papworth Hospital | Cambridge | Cambridgeshire | CB23 3RE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31277053 | Derived | 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. |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D009203 | Myocardial Infarction |
| D015427 | Reperfusion Injury |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| C055453 | glucagon-like peptide 1 (7-36)amide |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
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| placebo | Drug | Normal saline |
|
| Plasma Creatine Kinase - Myocardial Bound (CKMB) level | CKMB level on blood test at 6 hours following angioplasty or stenting | 6 hours |
| Myocardial Flow Grade after Angioplasty or Stenting | Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale | Measured during procedure |
| 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 |
| 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 |
| Ischaemic symptoms during balloon occlusion | Presence or absence or of symptoms of myocardial ischaemia during the procedure | Assessed during procedure |
| Myocardial Blush Grade following angioplasty or stenting | Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale | Measured during procedure |
| Electrocardiographic (ECG) Changes during procedure | Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure | Assessed during procedure |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D011183 | Postoperative Complications |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |