Cardiac Cell Therapy Network | RFA
This initiative involves investigators from multiple departments, including Medicine, Pathology, Cardiac Surgery, and Pediatrics.
Background
- RFA for Stem cell tx for cv disease
- LV dysfunction patients undergoing device tx
- Network of 5 clinical centers (VU applying for one), one DCC
- Demo experience in multi-center trials
- Commit to disseminate results
- Phase I/II studies
- Sample size calculations
- Will choose 2 protocols
- $300K/yr including co-Is at >= 10% FTE
- Development core for young clinical investigators
- 2 page proposal by 27Jan06 describing 2 protocols with sample sizes
- Main proposal 10Mar06 if first one accepted
Goals
- Cell delivery
- ID cell types for tx
- Track cells, standardize cell/tx procedures
- Evaluate patient groups
- Define endpoints
- Knowledge base for tx decisions
- Dissemination and training
Possible Endpoints
Physiologic
- Exercise capacity
- Hemodynamics
- Health/function survey
- HRV (non-specific but sensitive)
Ventricular Structure/Function
- MRI (gold standard but can't use in ICD or pacemaker patients)
- 3d Echo (tissue Doppler)
- RVG (MUGA), (LVEF, regional EF, LV volume)
- Contractile reserve (LVSWI, stress LV function)
Cell Survival
- Biomarkers
- PET scan (metabolism)
- MRI
Biochemical
Electrical
- EKG
- Holter/event monitorhtthttp://www.cnn.com/http://www.cnn.com/http://www.cnn.com/p://www.cnn.com/
- Signal-averaged EKG
Experimental Designs
Protocol 1
- 2 * 2 * 2 factorial design
Protocol 2
Sample Size Calculation
Based on precision or power
Information needed from the clinician
- Pick primary/most important outcome
- Standard errors of each group from the primary/pilot/animal study