GLP-1 Loading During Elective Percutaneous Coronary Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2021-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Angina Pectoris Myocardial Infarction Reperfusion Injury Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Normal Saline

Infusion of Normal Saline during Percutaneous Coronary Intervention

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Normal saline

GLP-1

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

Group Type EXPERIMENTAL

GLP-1

Intervention Type DRUG

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

Interventions

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GLP-1

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

Intervention Type DRUG

placebo

Normal saline

Intervention Type DRUG

Other Intervention Names

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GLP-1 (7-36) amide

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No