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Cardiac Cell Therapy Network |
RFA
This initiative involves investigators from multiple departments, including Medicine, Pathology, Cardiac Surgery, and Pediatrics.
Biostatisticians:
Cindy Chen
,
Frank Harrell
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
BND,
TNF,
CMP
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 2
P with GCSF
BM
Control
IM Per
Im Per
N
N
N
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Topic revision: r1 - 17 Dec 2005,
FrankHarrell
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