search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia; a registry.


- candidate number9818
- NTR NumberNTR2962
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2011
- Secondary IDsP05.025 MEC LUMC
- Public TitleIntramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia; a registry.
- Scientific TitleIntramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia; a registry.
- ACRONYM
- hypothesisThe aim of this study is to provide more insight in the therapeutic effect and mechanism of action of intramyocardial bone marrow cell injection in patients with refractionary angina pectoris and documented ischemia.
- Healt Condition(s) or Problem(s) studiedBone marrow cells, Refractory angina pectoris, Intramyocardial injection, Stem cell therapy
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 20-okt-2008
- planned closingdate1-jan-2013
- Target number of participants150
- InterventionsAfter 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.
In patients NOGA mapping will be performed with subsequent intramyocardial injection of autologous bone marrow-derived mononuclear cells.
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 outcomeThe change in myocardial perfusion (SPECT) at 3 monhts follow-up relative to baseline.
- Secondary outcomeEFFICACY:
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.
- TimepointsAt 3 and 6 months follow-up.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. D.E. Atsma
- CONTACT for SCIENTIFIC QUERIESDr. D.E. Atsma
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Cardiology
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryAfter 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.
In patients NOGA mapping will be performed with subsequent intramyocardial injection of autologous bone marrow-derived mononuclear cells. 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)
- RECORD24-jun-2011 - 11-jul-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl