Clinical trial NCT00835848: Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI
Official title: Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI in Patients With STEMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: ST-segment elevation myocardial infarction
Primary PCI
Postconditioning
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2009-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Infarct size by MRI
timeFrame: 3 months
Secondary outcomes:
measure: Cardiel death after 1 and 15 months.
timeFrame: 15 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Heart Center, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Thomas Engstrom, MD, PhD, DSci
role: STUDY_CHAIR
References:
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.
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.
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.