Status:
TERMINATED
Effects of Intracoronary Progenitor Cell Therapy on Coronary Flow Reserve After Acute MI
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Collaborating Sponsors:
University of Leipzig
Conditions:
Coronary Artery Disease
Acute Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Coronary flow reserve is an important measure of the integrity of the coronary microcirculation. Moreover, impaired coronary flow reserve is a predictor of future cardiovascular events and poor progno...
Detailed Description
Improvement of neovascularization is a key mechanism of functional improvement of intracoronary application of progenitor cells after acute myocardial infarction. Since capillary density cannot be ass...
Eligibility Criteria
Inclusion
- Patients with acute coronary syndrome (ST-depression in at least 2 leads \> 0,1 mV), or T-wave inversion, with or without elevated myocardial biomarkers (Troponin T oder I), together with typical clinical presentation), treated as follows:
- Acute percutaneous revascularization with stent implantation within 48 hours after symptom onset.
- Successful acute PCI (residual stenosis \< 30%, TIMI flow \> 2).
- Hemodynamic stability
- Age 18 - 80 years
- Written informed consent
- Active contraception in women of childbearing age
Exclusion
- Patients with STEMI (ST elevation in 2 leads above 0,2 mV in lead V1, V2 oder V3 or above 0,1 mV in the other leads)
- Necessity of additional PCI in non-infarct vessel at the time of study therapy (multi-vessel PCI in the acute event is possible)
- Heart failure (LVEF ≤ 30 %).
- Arteriovenous malformation or aneurysms
- Active infection (C-reactive protein \> 10 mg/dl), or fever, or diarrhoea within the last 4 weeks
- Chronic inflammatory disease
- HIV infection or active hepatitis
- Neoplastic disease without documented complete remission within the last 5 years
- Recent stroke within the last 3 months
- Impaired kidney function (creatinin \> 2,5 mg/dl) at the time of treatment
- Significant liver disease (GOT \> 2x upper normal value or spontaneous INR \> 1,5.
- Hematopoetic disease (anaemia with Hb\< 8.5 mg/dl; thrombocytopenia \< 100.000/µl; splenomegaly
- Known allergies to Clopidogrel, Heparin or Abciximab
- History of bleeding disorder
- GI bleeding within the last 3 months
- Major surgery or trauma within the last 2 months
- Uncontrolled hypertension
- Pregnancy
- Mental disability
- Previous progenitor cell therapy
- Participation in a different clinical trial within the last 30 days
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00711542
Start Date
September 1 2008
End Date
December 1 2015
Last Update
January 12 2017
Active Locations (2)
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1
Med. Klinik III; Kardiologie
Frankfurt, Germany, 60590
2
Universität Leipzig / Herzzentrum
Leipzig, Germany, 04289