| - candidate number | 1645 |
| - NTR Number | NTR400 |
| - ISRCTN | ISRCTN58194927 |
| - Date ISRCTN created | 27-jan-2006 |
| - date ISRCTN requested | 18-nov-2005 |
| - Date Registered NTR | 13-sep-2005 |
| - Secondary IDs | N/A |
| - Public Title | 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. |
| - Scientific Title | 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. |
| - ACRONYM | N/A |
| - hypothesis | The aim of this study is to determine the safety and efficacy of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented myocardial ischemia. |
| - Healt Condition(s) or Problem(s) studied | Angina Pectoris, Myocardial ischemia |
| - Inclusion criteria | 1. Severe refractory angina despite optimal medical therapy; 2. Reversible ischemia on GATED-SPECT; 3. No candidate for (repeat) revascularization (CABG or PCI); 4. Male or female, > 18 years old; 5. Patients must be stable (e.g. not be in a setting of life-threatening heart failure); 6. Written informed consent. |
| - 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); 3. Unexplained haematological or biochemical abnormalities; 4. Concurrent participation in a study using an experimental drug or an experimental procedure within 6 months before the injection procedure; 5. Other severe concurrent illnesses (e.g. active infection, aortic stenosis, renal failure); 6. Bleeding diathesis or HIV infection; 7. Inability to follow the protocol and comply with follow-up requirements. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-mei-2005 |
| - planned closingdate | 1-mei-2007 |
| - Target number of participants | 50 |
| - Interventions | After written informed consent has been obtained, quality of life and exercise capacity will be investigated. In addition myocardial function and perfusion will be documented. Bone marrow will be aspired from the iliac crest under local anesthesia. Patients will be randomised to receive bone marrow cells or placebo. In all patients NOGA mapping will be performed with subsequent intramyocardial injection of autologous bone marrow-derived mononuclear cells or placebo. Quality of life and exercise capacity will be reassessed at 3 and 6 monhts follow-up. In addition, changes in myocardial function and perfusion will be evaluated at 3 months follow-up. |
| - Primary outcome | The change in myocardial perfusion (SPECT) at 3 monhts follow-up relative to baseline. |
| - Secondary outcome | EFFICACY: Clinical end points: 1. Angina frequency; 2. Canadian cardiovascular society score; 3. Quality of life; 4. Exercise capacity; Functional end points: 5. Change in LV ejection fraction at 3 monhts follow-up; 6. Regional myocardial function on a segmental base at 3 monhts follow-up; Safety: 7. Occurence of ahrrythmias; 8. Pericardial effusion > 5 mm (echo); 9. Myocardial damage; 10. Severe inflammation. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Research Fellow Jan Ramshorst, van |
| - CONTACT for SCIENTIFIC QUERIES | Drs. S.L.M.A. Beeres |
| - Sponsor/Initiator | Leiden University Medical Center (LUMC), Department of Cardiology |
| - Funding (Source(s) of Monetary or Material Support) | Leiden University Medical Center (LUMC) |
| - Publications | N/A |
| - Brief summary | After written informed consent has been obtained, quality of life and exercise capacity will be investigated. In addition myocardial function and perfusion will be documented. Bone marrow will be aspired from the iliac crest under local anesthesia. Patients will be randomised to receive bone marrow cells or placebo. In all patients NOGA mapping will be performed with subsequent intramyocardial injection of autologous bone marrow-derived mononuclear cells or placebo. Quality of life and exercise capacity will be reassessed at 3 and 6 monhts follow-up. In addition, changes in myocardial function and perfusion will be evaluated at 3 months follow-up. |
| - Main changes (audit trail) | |
| - RECORD | 13-sep-2005 - 29-nov-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl