STem cElls Mobilization in Acute Myocardial Infarction Outcome Trial
Stopped: Upon DSMC suggestion due to a too low enrollment rate.
Italy532 participantsStarted 2013-10
Plain-language summary
The purpose of this study is to demonstrate that granulocyte colony-stimulating factor (G-CSF) therapy in addition to state-of-the-art treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patients with reduced left ventricular ejection fraction (LVEF) (≤45%) after successful reperfusion for large anterior acute myocardial infarction.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients affected by acute anterior ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) or PCI-rescue with persistent occlusion of coronary artery,
* Time symptom-to-balloon (≥3 h and ≤12h or ≤24 h if symptoms persist),
* Thrombolysis in Myocardial Infarction (TIMI) flow post PCI ≥2,
* Evidence of left ventricular (LV) dysfunction (EF biplane ≤45%) ≤24 h after revascularization,
* Men and women aged ≥18 years and ≤75 years,
* Informed consent must be signed before proceeding with any study procedure.
Exclusion Criteria:
* Previous anterior MI,
* Recent MI (within 1 month),
* Known previous LV dysfunction (EF \<45%),
* Patients with angiographic evidence of coronary anatomy not suitable for PCI, or needing coronary artery bypass grafting (CABG),
* Valve disease requiring surgical correction,
* History of previous cardiac surgery or PCI on LAD within 6 months,
* Previous or current documented history of leukemia, myeloproliferative or myelodysplastic disorder,
* Previous or current documented history of malignant disease,
* Haemoglobin \<10 mg/dl,
* White blood cells (WBC) \>25.000 mm3,
* Platelet \<50.000 mm3,
* Sepsis,
* Known HIV infection,
* Immune system diseases,
* Interstitial lung disease
* Serious concomitant medical conditions (other than ischemic heart disease),
* Pregnancy and breast feeding,
* Documented alcohol and drug abuse,
* Anticipated poor compliance.
* Current participation in a cli…
What they're measuring
1
The composite endpoint of: - All cause death or, - recurrence of myocardial infarction (MI) or, - hospitalization due to heart failure.