Extracorporal shock wave therapy for induction of therapeutic neovascularization and homing of bone marrow progenitor cells in patients with chronic ischemic heart disease - Cell-Wave-CHF

Phase 1

• Conditions: Patients with ischemic coronary artery disease (congestive heart failure) and s/p anterior myocardial infarction

• Registration Number: EUCTR2005-005709-50-DE
• Lead Sponsor: Cardiology, University of Frankfurt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-09
• Study Completion: 2011-05-31
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

·Patients with chronic ischemic cardiomyopathy
·s/p anterior myocardial infarction > 3 months
·18-80 years
·Male or female
·Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Myocardial infarction < 3 months
·ventricular thrombus
·acute infection or fever
·chronic inflammatory diseases ( M. Crohn, Rheumatoid Arthritis)
·HIV Infection or active Hepatitis
·Neoplastic Diseases without complete remission in the last 5 years
·Stroke within 3 months
·renal insufficiency (Kreatinin > 2 mg/dl) before treatment
·Liver disease (GOT > 2x upper limit, or spontaneous INR > 1,5).
·Anemia (Hemoglobin < 10 mg/dl)
·Platelets <100.000/µl
·Known allergies to aspirin, clopidogrel or heparin
·bleeding disorder
·gastrointestinal bleeding within last 3 months
·surgery or trauma < 2 months
·pregnancy
·mental retardation
·Inclusion in other study within last 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified