A Phase 2 interventional study of GLP-1 and placebo in Angina Pectoris, Myocardial Infarction and Reperfusion Injury, sponsored by Papworth Hospital NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by Papworth Hospital NHS Foundation Trust · Phase 2, Interventional, and Treatment
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 193 is above the median of 100 across 1,779 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Papworth Hospital NHS Foundation Trust is the lead sponsor of 62 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Infusion of Normal Saline during Percutaneous Coronary Intervention
Drug: placebo
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
Also known as: GLP-1 (7-36) amide
Normal saline
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.
Time frame: 6 Hours following angioplasty or stenting
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.
Time frame: From date of randomisation until the date of first event assessed up to 6 months
Plasma Creatine Kinase - Myocardial Bound (CKMB) level
CKMB level on blood test at 6 hours following angioplasty or stenting
Time frame: 6 hours
Myocardial Flow Grade after Angioplasty or Stenting
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Assessed during procedure
Myocardial Blush Grade following angioplasty or stenting
Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale
Time frame: Measured during procedure
Electrocardiographic (ECG) Changes during procedure
Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure
Time frame: Assessed during procedure
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Papworth Hospital NHS Foundation Trust