Phase
Condition
Congestive Heart Failure
Heart Defect
Coronary Artery Disease
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with acute myocardial infarction (ST elevation in at least 2 leads >= 0.2 mVin V1,V2 or V3 or >= 0.1 mV in other leads), treated by one of the followingprocedures
Either acute PCI with stent implantation within 24 hours after symptom onset or
treatment with thrombolysis within 12 hours of symptom onset followed by PCI withstent implantation within 24 hours after thrombolysis.
Acute PCI / stent implantation has been successful (residual stenosis visually < 30%and TIMI flow >= 2).
At the time of inclusion patient does no longer require i.v. catecholamines ormechanical hemodynamic support (aortic balloon pump)
Significant regional wall motion abnormality in LV angiogram at the time of acute PCI (ejection fraction <= 45% on visual estimation).
Maximal CK elevation >= 400 U/l (measured at 37° C) with significant MB fraction > 6%
Age 18 - 80 Years
Written informed consent
Exclusion
Exclusion Criteria:
Regional wall motion abnormality outside the area involved in the index acutemyocardial infarction.
Need to revascularize additional vessels, outside the infarct artery.
Arteriovenous malformations or aneurysms
Active infection (CRP > 10 mg/dl) now, or fever or diarrhea within last 4 weeks.
Chronic inflammatory disease
HIV infection or active hepatitis
Neoplastic disease without documented remission within the past 5 years.
Cerebrovascular insult within 3 months
Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy
Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
Anemia (hemoglobin < 8.5 mg/dl)
Platelet count < 100.000/µl
Hypersplenism
Known allergy or intolerance to clopidogrel, heparin or abciximab.
History of bleeding disorder
Gastrointestinal bleeding within 3 months
Major surgical procedure or traumata within 2 months
Uncontrolled hypertension
Pregnancy
Mental retardation
Previously performed stem / progenitor cell therapy
Participation in another clinical trial within the last 30 days.
Study Design
Study Description
Connect with a study center
Zentralklinik Bad Berka
Bad Berka, 99437
GermanySite Not Available
Kerckhoff Klinik
Bad Nauheim, 61231
GermanySite Not Available
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
GermanySite Not Available
BG Kliniken Bergmannsheil
Bochum, 44789
GermanySite Not Available
Klinikum Lippe
Detmold, 32756
GermanySite Not Available
J. W. Goethe University Hospitals
Frankfurt, 60590
GermanySite Not Available
Rotes-Kreuz Krankenhaus - Kardiologisches Centrum
Frankfurt, 60316
GermanySite Not Available
Universitätsklinkum Giessen
Giessen, 35392
GermanySite Not Available
Parxis Schofer, Mathey und Partner
Hamburg, 22763
GermanySite Not Available
Universitätsklikum Homburg
Homburg/Saar, 66421
GermanySite Not Available
Klinikum Kassel
Kassel, 34125
GermanySite Not Available
Herzzentrum - Universität Leipzig
Leipzig, 04289
GermanySite Not Available
Herzzentrum Ludwigshafen
Ludwigshafen, 67073
GermanySite Not Available
Universitätsklinik Mainz
Mainz, 55131
GermanySite Not Available
Universitätsklinikum Mannheim
Mannheim, 68167
GermanySite Not Available
Zentralklinikum Suhl
Suhl, 98527
GermanySite Not Available
Universitätsspital Zürich
Zürich, 8091
SwitzerlandSite Not Available
Universitätsspital Zürich
Zürich, 8091
SwitzerlandSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.