No registrations found.
ID
Source
Brief title
Health condition
Refractory angina pectoris and documented myocardial ischemia.
Sponsors and support
Leiden University Medical Center ,
Leiden,
the Netherlands
Intervention
Outcome measures
Primary outcome
The change in myocardial perfusion (SPECT) at 3 monhts follow-up relative to baseline.
Secondary outcome
EFFICACY:
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.
Background summary
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.
Study objective
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.
Study design
N/A
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 reassessed at 3 and 6 monhts follow-up. In addition, changes in myocardial function and perfusion will be evaluated at 3 months follow-up.
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
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
Inclusion criteria
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.
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 HIV infection;
7. Inability to follow the protocol and comply with follow-up requirements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL361 |
| NTR-old | NTR400 |
| Other | : N/A |
| ISRCTN | ISRCTN58194927 |