Randomized, double blind, placebo controlled trial of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia.
Completed
- Conditions
- Refractory angina pectoris and documented myocardial ischemia.
- Registration Number
- NL-OMON29227
- Lead Sponsor
- Departmartement of Cardiology,Leiden University Medical Center ,Leiden, the Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Severe refractory angina despite optimal medical therapy;
2. Reversible ischemia on GATED-SPECT;
Exclusion Criteria
1. Acute myocardial infarction, PCI or CABG within 6 months of enrolment in the study;
2. History of malignancy (except low grade and fully resolved non-melanoma skin malignancy);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in myocardial perfusion (SPECT) at 3 monhts follow-up relative to baseline.
- Secondary Outcome Measures
Name Time Method EFFICACY: <br /><br>Clinical end points:<br><br />1. Angina frequency; <br /><br>2. Canadian cardiovascular society score; <br />3. Quality of life; <br /><br>4. Exercise capacity;<br /><br /><br>Functional end points:<br /><br>5. Change in LV ejection fraction at 3 monhts follow-up; <br /><br>6. Regional myocardial function on a segmental base at 3 monhts follow-up;<br><br /><br /><br>Safety:<br /><br>7. Occurence of ahrrythmias; <br /><br>8. Pericardial effusion > 5 mm (echo); <br />9. Myocardial damage; <br /><br>10. Severe inflammation.