Status:
UNKNOWN
Prospective, Controlled and Randomized Clinical Trial on Cardiac Cell Regeneration With Laser and Autologous Bone Marrow Stem Cells, in Patients With Coronary Disease and Refractory Angina
Lead Sponsor:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Conditions:
Angina
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Coronary disease is one of the most frequent pathology of the modern world and the leading cause of death in the investigators country. In Spain more than 50.000 coronary percutaneous intervention and...
Eligibility Criteria
Inclusion
- Patients over 18 years of age.
- Patients with at least one area of myocardial ischemia or chronic myocardial infarction of the left ventricle demonstrated by any imaging technique not amenable to conventional revascularization and angina refractory to medical treatment.
- Ejection fraction\> 25% measured in the six months prior to the procedure.
- Participants must be mentally competent to give consent for inclusion in the clinical trial
Exclusion
- Patients with unstable angina defined as the need for intravenous nitrates at the time of surgery.
- Recent myocardial infarction (within 15 days before the procedure).
- Patients with decompensated heart failure at the time of surgery.
- Severe or life threatening arrhythmia (ventricular tachycardia or fibrillation) in the week before the procedure.
- Patients requiring some type of concomitant valvular surgery.
- Patients with severe obstructive lung disease criteria who are considered as not capable of bearing general anesthesia
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01214499
Start Date
October 1 2010
End Date
October 1 2012
Last Update
November 30 2010
Active Locations (1)
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1
Hospital Universitario de La Princesa
Madrid, Madrid, Spain, 28006