Diffuse Coronary Artery Disease (CAD) and non candidates for coronary artery intervention Circulatory System
Conditions
Interventions
Patients are randomised into the experimental group and the control group (2:1) based on an automatically generated random number table.
Experimental group: G-CSF mobilized autologous circulating hem
Sponsors
Chang Gung Memorial Hospital, Chang Gung Medical Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 20-80 y/o, coronary syndrome, subjects with severe diffuse coronary artery disease who have been diagnosed by cardiac catheterization, not suitable for cardiac catheterization or surgical coronary artery bypass surgery after cardiac internist and surgeons evaluate, and receiving optimal medical therapy, including antiplatelet therapy (aspirin or clopidogrel), ACEI/ARB, beta-blocker, calcium channel blocker, nitrates, etc. The symptom of chest pain is still evaluated as Canadian Cardiovascular Society class II-IV Angina. LVEF =55 % examined by 3D echo (i.e. LVEF =60 % indicates normal. After stem cell treatment, the LVEF is improved up to 5 %, unchanged or continually deteriorated. Therefore, the criteria of enrollment of LVEF is =55 %). Patients are willing to accept the G-CSF mobilized autologous circulating hematopoietic stem/progenitor cells (CPC) treatment through cardiac catheterization, and are willing to join this study follow-up. The severe diffuse coronary artery disease is defined as follows: 1. Clinical symptoms of angina (Canadian Cardiovascular Society class II-IV) 2. Tl-201 scan presents reversible ischemic changes (results should be adopted within 6 months) 3. Highly diffuse vascular lesions show in angiography results (continuous normal segmental vessels length no longer than 10 mm), and the degree of stenosis more than 75% (results can be adopted within 6 months) 4. Due to vascular occlusion showed diffuse and too small, not to be suitable for PCI (angioplasty nowhere to be implemented) or CABG (which can be accessed at no normal blood vessels) analyzed by PCI and CABG experts. The vessel must be severe diffuse stenosis (unsuitable for CABG)
Exclusion criteria
Exclusion criteria: 1. Age 80 y/o 2. Pregnant or breastfeeding women 3. No adventitious agents, ex. HIV infection, HBV and HCV carriers (HBsAg+ or anti-HCV +) (subjects without examination of HIV, HBV and HCV are excluded) 4. Myocardial infarction within 3 months, stent placement within 3 months 5. Severe aortic or mitral stenosis 6. Asthma and not suitable for cardiac catheterization treatment (including NYHA functional class IV) 7. Malignant or hematologic disease. Severe disease with life span less than one year 8. Chronic kidney disease (CCr <20 ml/min) and patients receiving dialysis 9. Under immunosuppressive medications 10. Autoimmune diseases 11. Contraindication to G-CSF 12. The subject previously received cell therapy 13. Participating in another clinical study and planning to participate in another clinical study during the course of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction (LVEF) examined by 3D echo and cardiac MRI at baseline (D6) and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The incidence of death monitored from baseline (D6) to 12 months during one-year follow-up 2. The incidence of major cardiac events (i.e., defined as the occurrence of myocardial infarction, congestive heart failure, or refractory angina) monitored from baseline (D6) to 12 months during one-year follow-up 3. Heart failure evaluated according to NYHA functional class. The left ventricular ejection fraction (LVEF) is measured by cardiac ultrasonography at baseline and each revisit (1 week, 1 month, 3 months, 6 months, 9 months, and 12 months) to evaluate the left ventricular systolic function. The heart function of subjects (NYHA Functional Class) from mild to severe is divided from Class I to Class IV for assessing the improvement of heart failure 4. The symptom severity of angina pectoris assessed according to the Canadian cardiovascular society grading system at baseline and each revisit (1 week, 1 month, 3 months, 6 months, 9 months, and 12 months). Exertion-induced angina from mild to severe is divided from Class I to Class IV for assessing the improvement of angina pectoris | — |
Countries
Taiwan
Contacts
Public ContactHon-Kan Yip
Outcome results
None listed