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)


Efficacy assessment of REpeat intramyocardial INJECTion of autologous bone marrow cells in previously responding no-option patients with residual or recurrent refractory Angina Pectoris and documented ischemia.


- candidate number8816
- NTR NumberNTR2664
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-dec-2010
- Secondary IDsNL30970.000.10 CCMO
- Public TitleEfficacy assessment of REpeat intramyocardial INJECTion of autologous bone marrow cells in previously responding no-option patients with residual or recurrent refractory Angina Pectoris and documented ischemia.
- Scientific TitleEfficacy assessment of repeat intramyocardial injection of autologous bone marrow cells in previously responding no-option patients with residual or recurrent refractory angina pectoris and documented ischemia.
- ACRONYMRE-INJECT AP
- hypothesisThe aim of this study is determining whether repeat intramyocardial injection of bone marrow cells is safe and effective in the treatment of refractionary angina pectoris.
- Healt Condition(s) or Problem(s) studiedBone marrow cells, Refractory angina pectoris, Intramyocardial injection
- Inclusion criteria1. Having received intramyocardial bone marrow cell injection in study P02.051 (Injection of Autologous Bone Marrow Cells into Damaged Myocardium of No-option Patients with Refractory Angina Pectoris and Ischemia, a two-phased study of safety, feasibility and efficacy) or P05.025 (Efficacy assessment of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia, a randomized, double blind, placebo controlled study);
2. Disabling refractory angina pectoris despite optimal medical therapy;
3. Residual reversible ischemia on GATED-SPECT imaging;
4. No candidate for (repeat) revascularization;
5. Male or female, > 18 years old;
6. Patients must be stable and not be in a setting of life-threatening heart failure (LVEF>35%);
7. Able to perform an exercise tolerance test prior to therapy;
8. Able and willing to undergo all the tests used in this protocol including the traveling involved;
9. Written informed consent.
- Exclusion criteria1. Evidence of cancer (except low grade and fully resolved non-melanoma skin malignancy) as bone marrow cell infusion might promote tumor growth through induction of angiogenesis in the tumor;
2. Concurrent participation in a study using an experimental drug or an experimental procedure within 2 months before the injection procedure;
3. Other severe concurrent illnesses (e.g. active infection, aortic stenosis, renal failure);
4. Bleeding diathesis or HIV infection;
5. Any other condition that, in the opinion of the investigator, could pose a significant threat to the subject if the investigational therapy was to be initiated;
6. Inability to undergo cardiac catheterization or nuclear testing;
7. Inability to follow the protocol and comply with follow-up requirements;
8. Candidates for surgical of percutaneous intervention;
9. Mechanical aortic valve prosthesis.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 22-dec-2010
- planned closingdate1-jan-2012
- Target number of participants23
- Interventions1. After written informed consent has been obtained, quality of life and exercise capacity will be investigated. Myocardial perfusion and function will be documented;
2. Bone marrow will be aspired from the iliac crest under local or general anesthesia;
3. In all patients NOGA mapping will be performed with subsequent intramyocardial injection of autologous bone marrow-derived mononuclear cells;
4. Quality of life, ccs class and exercise capacity will be reassessed at 3 and 6 monhts follow-up. In addition, changes in myocardial function perfusion and function will be evaluated at 3 months follow-up.
- Primary outcomeThe change in myocardial perfusion at 3 months follow-up relative to baseline.
- Secondary outcomeClinical end points:
1. Canadian cardiovascular society score;
2. Quality of life (translated Seattle angina questionnaire);
3. Exercise capacity.

Functional end points:
1. Left ventricular ejection fraction at 3 monhts follow-up.

Safety:
1. Occurence of ahrrythmias;
2. Pericardial effusion > 5 mm (echo);
3. Myocardial damage;
4. 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 summaryN/A
- Main changes (audit trail)
- RECORD23-dec-2010 - 3-jan-2011


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