Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI

NCT00835848 | Completed Phase 4

• 1 other identifier: KF 01 326257 b
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

ST-segment elevation myocardial infarction; Primary PCI; Postconditioning

Outcome Measures

Primary Outcomes (1)

• Infarct size by MRI

  3 months

Secondary Outcomes (1)

• Cardiel death after 1 and 15 months.

  15 months

Study Arms (2)

Exenatide

ACTIVE COMPARATOR

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.

Drug: Exenatide

Saline

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Exenatide DRUG

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.

Exenatide

Saline DRUG

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.

Saline

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (1)

Heart Center, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (3)

• 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.

  PMID: 28286967 DERIVED

• 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.

  PMID: 22496084 DERIVED

• 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.

  PMID: 21920963 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Exenatide; Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Thomas Engstrom, MD, PhD, DSci

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief consultant

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2015
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

DK (1)