GLP-1 Loading During Elective Percutaneous Coronary Intervention

NCT02127996 | Unknown Phase 2 DMC

• 1 other identifier: P01799
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina Pectoris; Myocardial Infarction; Reperfusion Injury; Coronary Heart Disease

Keywords

Angina Pectoris; Percutaneous Coronary Intervention; Myocardial Infarction; Glucagon-Like Peptide 1; Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates

  From date of randomisation until the date of first event assessed up to 6 months

• Plasma Creatine Kinase - Myocardial Bound (CKMB) level

  6 hours

• Myocardial Flow Grade after Angioplasty or Stenting

  Measured during procedure

• MACCE Rates

  From date of randomisation until the date of first event assessed up to 12 months

• MACCE Rates

  From date of randomisation until the date of first event assessed up to 60 months

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Infusion of Normal Saline during Percutaneous Coronary Intervention

Drug: placebo

GLP-1

EXPERIMENTAL

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

Drug: GLP-1

Interventions

GLP-1 DRUG

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

Also known as: GLP-1 (7-36) amide

GLP-1

placebo DRUG

Normal saline

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective PCI
• Age over 18
• Able to give informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Papworth Hospital

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31277053 DERIVED

MeSH Terms

Conditions

Angina Pectoris; Myocardial Infarction; Reperfusion Injury; Coronary Disease

Interventions

Glucagon-Like Peptide 1; glucagon-like peptide 1 (7-36)amide

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis; Postoperative Complications

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Stephen Hoole, MA MD FRCP

  Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 1, 2014
• Study Start: March 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: July 1, 2021
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

GB (1)