GLP-1 Loading During Elective Percutaneous Coronary Intervention

Phase 2

• Conditions: Angina Pectoris; Myocardial Infarction; Reperfusion Injury; Coronary Heart Disease
• Interventions: Drug: placebo; Drug: GLP-1

• Registration Number: NCT02127996
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Study Start: 2015-03
• Primary Completion: 2017-03-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-06
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	placebo	Infusion of Normal Saline during Percutaneous Coronary Intervention
GLP-1	GLP-1	Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Electrocardiographic (ECG) Changes during procedure	Assessed during procedure	Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure
Ischaemic symptoms during balloon occlusion	Assessed during procedure	Presence or absence or of symptoms of myocardial ischaemia during the procedure
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 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.
Myocardial Blush Grade following angioplasty or stenting	Measured during procedure	Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale

Trial Locations

Locations (1)

Papworth Hospital; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom