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Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI (POSTCON II)

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Exenatide
Saline
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring ST-segment elevation myocardial infarction, Primary PCI, Postconditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • More than 18 years of age.
  • STEMI less than 12 hours from onset of pain. STEMI defined as as ST-segment elevation in 2 contiguous electrocardiographic leads of >0.1 mV in V4 - V6 or limb leads II, III and aVF, or >0.2 mV in lead V1 - V3.
  • TIMI 0-1 in infarct related artery.
  • Oral and written informed consent.

Exclusion Criteria:

  • Multivessel disease defined by one or more stenoses >70% in diameter in the non infarct related artery.
  • Previous myocardial infarction.
  • Stent trombosis.
  • Previous CABG.
  • Less than TIMI 2 following wiring and predilatation of the infarct related artery but prior to postconditioning or placebo treatment.
  • Renal insufficiency (creatinin >200).
  • Pregnancy or lactation.
  • Diabetic ketoacidose eller hypoglycemia (plasma glukose < 2.5 mmol/l).
  • Pancreatitis.

Sites / Locations

  • Heart Center, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exenatide

Saline

Arm Description

25 μg Byetta (Lilly, Exenatide) is added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

Isotonic saline infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

Outcomes

Primary Outcome Measures

Infarct size by MRI

Secondary Outcome Measures

Cardiel death after 1 and 15 months.

Full Information

First Posted
February 3, 2009
Last Updated
May 4, 2015
Sponsor
Rigshospitalet, Denmark
Collaborators
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00835848
Brief Title
Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI
Acronym
POSTCON II
Official Title
Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI in Patients With STEMI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
University Hospital, Gentofte, Copenhagen

4. Oversight

5. Study Description

Brief Summary
Both pre- and postconditioning seem to protect cardiomyocytes during reperfusion therapy. Investigations both ex vivo and in vivo suggest that a gut derived hormone, Glucagon-Like-Peptide-1 (GLP-1), is able to reduce reperfusioninjury after myocardial ischemia. Results from our own laboratory have shown a marked reduction in infarct size when rat hearts in a Langendorf preparation were exposed to the GLP-1 analogue, exendin-4. The investigators want to investigate to what extent this effect can be translated to humans in the setting of acute STEMI treated with primary PCI when evalutaed by cardiac magnetic resonance imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
ST-segment elevation myocardial infarction, Primary PCI, Postconditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exenatide
Arm Type
Active Comparator
Arm Description
25 μg Byetta (Lilly, Exenatide) is added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Isotonic saline infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Intervention Description
Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 25 μg Byetta (Lilly, Exenatide) and 0.1% human albumine are added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 0.1% human albumine is added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.
Primary Outcome Measure Information:
Title
Infarct size by MRI
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cardiel death after 1 and 15 months.
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: More than 18 years of age. STEMI less than 12 hours from onset of pain. STEMI defined as as ST-segment elevation in 2 contiguous electrocardiographic leads of >0.1 mV in V4 - V6 or limb leads II, III and aVF, or >0.2 mV in lead V1 - V3. TIMI 0-1 in infarct related artery. Oral and written informed consent. Exclusion Criteria: Multivessel disease defined by one or more stenoses >70% in diameter in the non infarct related artery. Previous myocardial infarction. Stent trombosis. Previous CABG. Less than TIMI 2 following wiring and predilatation of the infarct related artery but prior to postconditioning or placebo treatment. Renal insufficiency (creatinin >200). Pregnancy or lactation. Diabetic ketoacidose eller hypoglycemia (plasma glukose < 2.5 mmol/l). Pancreatitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Engstrom, MD, PhD, DSci
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Center, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28286967
Citation
Huang M, Wei R, Wang Y, Su T, Li Q, Yang X, Chen X. Protective effect of glucagon-like peptide-1 agents on reperfusion injury for acute myocardial infarction: a meta-analysis of randomized controlled trials. Ann Med. 2017 Nov;49(7):552-561. doi: 10.1080/07853890.2017.1306653. Epub 2017 Mar 31.
Results Reference
derived
PubMed Identifier
22496084
Citation
Lonborg J, Kelbaek H, Vejlstrup N, Botker HE, Kim WY, Holmvang L, Jorgensen E, Helqvist S, Saunamaki K, Terkelsen CJ, Schoos MM, Kober L, Clemmensen P, Treiman M, Engstrom T. Exenatide reduces final infarct size in patients with ST-segment-elevation myocardial infarction and short-duration of ischemia. Circ Cardiovasc Interv. 2012 Apr;5(2):288-95. doi: 10.1161/CIRCINTERVENTIONS.112.968388. Epub 2012 Apr 10.
Results Reference
derived
PubMed Identifier
21920963
Citation
Lonborg J, Vejlstrup N, Kelbaek H, Botker HE, Kim WY, Mathiasen AB, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Thuesen L, Krusell LR, Jensen JS, Kober L, Treiman M, Holst JJ, Engstrom T. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012 Jun;33(12):1491-9. doi: 10.1093/eurheartj/ehr309. Epub 2011 Sep 14.
Results Reference
derived

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Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI

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