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 | https://doi.org/10.1186/ISRCTN58194927 |
| Secondary identifying numbers | NTR400 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 09/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S L M A Beeres
Scientific
Scientific
Leiden University Medical Centre
Department of Cardiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 2020 |
|---|---|
| s.l.m.a.beeres@lumc.nl |
Study information
| Study design | Randomised, double-blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Angina pectoris, myocardial ischaemia |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | The change in myocardial perfusion (SPECT) at 3 months follow-up relative to baseline. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/05/2005 |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Cardiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/english/start_english.html |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Centre (LUMC) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/05/2009 | Yes | No | |
| Results article | results | 01/03/2011 | Yes | No | |
| Results article | results | 01/11/2012 | Yes | No |
