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| Randomised, double blind, placebo controlled trial of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischaemia |
| ISRCTN | ISRCTN58194927 |
| ClinicalTrials.gov identifier | |
| Public title | Randomised, double blind, placebo controlled trial of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischaemia |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | NTR400 |
| Study 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 ischaemia. |
| Ethics approval | Received from the local medical ethics committee |
| Study design | Randomised, double-blind, placebo controlled, parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Angina pectoris, myocardial ischaemia |
| Participants - inclusion criteria |
1. Severe refractory angina despite optimal medical therapy
2. Reversible ischaemia on gated-single photon emission computed tomography (SPECT) 3. Not a candidate for (repeat) revascularisation (coronary artery bypass graft [CABG] or percutaneous coronary intervention [PCI]) 4. Male or female, greater than 18 years old 5. Patients must be stable (e.g. not be in a setting of life-threatening heart failure) 6. Written informed consent |
| Participants - 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 human immunodeficiency virus (HIV) infection 7. Inability to follow the protocol and comply with follow-up requirements |
| Anticipated start date | 01/05/2005 |
| Anticipated end date | 01/05/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 40 |
| 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 re-assessed at 3 and 6 months follow-up. In addition, changes in myocardial function and perfusion will be evaluated at 3 months follow-up. |
| Primary outcome measure(s) | The change in myocardial perfusion (SPECT) at 3 months follow-up relative to baseline. |
| Secondary outcome measure(s) |
Efficacy:
1. Clinical end points: 1.1. Angina frequency 1.2. Canadian cardiovascular society score 1.3. Quality of life 1.4. Exercise capacity 2. Functional end points: 2.1. Change in left ventricular (LV) ejection fraction at 3 months follow-up 2.2. Regional myocardial function on a segmental base at 3 months follow-up 3. Safety: 3.1. Occurrence of arrhythmias 3.2. Pericardial effusion greater than 5 mm (echo) 3.3. Myocardial damage 3.4. Severe inflammation |
| Sources of funding | Leiden University Medical Centre (LUMC) (Netherlands) |
| Trial website | |
| Publications | 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19454638 |
| Contact name | Dr S L M A Beeres |
| Address |
Leiden University Medical Centre
Department of Cardiology P.O. Box 9600 |
| City/town | Leiden |
| Zip/Postcode | 2300 RC |
| Country | Netherlands |
| Tel | +31 (0)71 526 2020 |
| Fax | +31 (0)71 526 6809 |
| s.l.m.a.beeres@lumc.nl | |
| Sponsor | Leiden University Medical Centre (LUMC) (The Netherlands) |
| Address |
Department of Cardiology
P.O. Box 9600 |
| City/town | Leiden |
| Zip/Postcode | 2300 RC |
| Country | Netherlands |
| Sponsor website: | http://www.lumc.nl/english/start_english.html |
| Date applied | 27/01/2006 |
| Last edited | 02/06/2009 |
| Date ISRCTN assigned | 27/01/2006 |
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