GLP-1 Loading During Elective Percutaneous Coronary Intervention (GOLD-PCI)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Papworth Hospital NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02127996
First received: April 24, 2014
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Angina Pectoris
Myocardial Infarction
Reperfusion Injury
Coronary Heart Disease
Drug: GLP-1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Protective Effects of Glucagon-like Peptide-1 (GLP-1) in Patients Undergoing Elective Angioplasty and Stenting (GOLD-PCI)

Resource links provided by NLM:


Further study details as provided by Papworth Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Plasma Troponin I level [ Time Frame: 6 Hours following angioplasty or stenting ] [ Designated as safety issue: No ]
    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:
  • Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates [ Time Frame: From date of randomisation until the date of first event assessed up to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    CKMB level on blood test at 6 hours following angioplasty or stenting

  • Myocardial Flow Grade after Angioplasty or Stenting [ Time Frame: Measured during procedure ] [ Designated as safety issue: No ]
    Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale

  • MACCE Rates [ Time Frame: From date of randomisation until the date of first event assessed up to 12 months ] [ Designated as safety issue: No ]
    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.

  • MACCE Rates [ Time Frame: From date of randomisation until the date of first event assessed up to 60 months ] [ Designated as safety issue: No ]
    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.

  • Ischaemic symptoms during balloon occlusion [ Time Frame: Assessed during procedure ] [ Designated as safety issue: No ]
    Presence or absence or of symptoms of myocardial ischaemia during the procedure

  • Myocardial Blush Grade following angioplasty or stenting [ Time Frame: Measured during procedure ] [ Designated as safety issue: No ]
    Graded between 0 and 3 on Thrombolysis in Myocardial Infarction (TIMI) Scale

  • Electrocardiographic (ECG) Changes during procedure [ Time Frame: Assessed during procedure ] [ Designated as safety issue: No ]
    Presence or absence of ECG changes reflective of myocardial ischaemia during the procedure


Estimated Enrollment: 400
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal Saline
Infusion of Normal Saline during Percutaneous Coronary Intervention
Experimental: GLP-1
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
Other Name: GLP-1 (7-36) amide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02127996

Contacts
Contact: Stephen Hoole, MA MD FRCP stephen.hoole@papworth.nhs.uk
Contact: Joel P Giblett, BM BSc MRCP jpg59@cam.ac.uk

Locations
United Kingdom
Papworth Hospital
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
Principal Investigator: Stephen Hoole, MA MD FRCP Papworth Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02127996     History of Changes
Other Study ID Numbers: P01799
Study First Received: April 24, 2014
Last Updated: April 29, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Papworth Hospital NHS Foundation Trust:
Angina Pectoris
Percutaneous Coronary Intervention
Myocardial Infarction
Glucagon-Like Peptide 1
Reperfusion Injury

Additional relevant MeSH terms:
Infarction
Heart Diseases
Myocardial Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Reperfusion Injury
Angina Pectoris
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Postoperative Complications
Chest Pain
Pain
Signs and Symptoms
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014