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 ischemia.
ID
Bron
Verkorte titel
Aandoening
Refractory angina pectoris and documented myocardial ischemia.
Ondersteuning
Leiden University Medical Center ,
Leiden,
the Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The change in myocardial perfusion (SPECT) at 3 monhts follow-up relative to baseline.
Achtergrond van het onderzoek
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 reassessed at 3 and 6 monhts follow-up. In addition, changes in myocardial function and perfusion will be evaluated at 3 months follow-up.
Doel van het onderzoek
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 ischemia.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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 reassessed at 3 and 6 monhts follow-up. In addition, changes in myocardial function and perfusion will be evaluated at 3 months follow-up.
Algemeen / deelnemers
Department of Cardiology <br>
Postal zone: C5-P<br>
P.O. Box 9600
Jan Ramshorst, van
Leiden 2300 RC
The Netherlands
+31 (0)71 5262020
j.van_ramshorst@lumc.nl
Wetenschappers
Department of Cardiology <br>
Postal zone: C5-P<br>
P.O. Box 9600
Jan Ramshorst, van
Leiden 2300 RC
The Netherlands
+31 (0)71 5262020
j.van_ramshorst@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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 HIV infection;
7. Inability to follow the protocol and comply with follow-up requirements.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL361 |
| NTR-old | NTR400 |
| Ander register | : N/A |
| ISRCTN | ISRCTN58194927 |