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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
DOI 10.1186/ISRCTN58194927
ClinicalTrials.gov identifier
EudraCT number
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.
Lay summary Not provided at time of registration
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 1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19454638
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21209073
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23137509
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
  Email 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 09/01/2013
Date ISRCTN assigned 27/01/2006
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