Cardiac Cell Therapy Network | RFA

This initiative involves investigators from multiple departments, including Medicine, Pathology, Cardiac Surgery, and Pediatrics.

E-mail list: igor.feoktistov@Vanderbilt.Edu, cindy.chen@vanderbilt.edu, david.bader@Vanderbilt.Edu, f.harrell@vanderbilt.edu, marvin.w.kronenberg@Vanderbilt.Edu, douglas.e.vaughan@Vanderbilt.Edu, john.byrne@Vanderbilt.Edu, scott.baldwin@Vanderbilt.Edu, tao.zhong@Vanderbilt.Edu, rebecca.r.hung@Vanderbilt.Edu, james.greelish@Vanderbilt.Edu, jeff.rottman@Vanderbilt.Edu, robert.piana@Vanderbilt.Edu, David.Zhao@Vanderbilt.Edu, Mark.Lawson@Vanderbilt.Edu, tsutomu.kume@Vanderbilt.Edu, antonis.hatzopoulos@vanderbilt.edu, thomas.g.disalvo@Vanderbilt.Edu, pampee.young@Vanderbilt.Edu, tammy.wingo@Vanderbilt.Edu, uchechukwu.sampson@Vanderbilt.Edu, david.slosky@Vanderbilt.Edu, laurie.a.hawkins@Vanderbilt.Edu, charles.lin@Vanderbilt.Edu, james.muldowney.iii@Vanderbilt.Edu, michelle.khoo@Vanderbilt.Edu, jeffrey.dendy@Vanderbilt.Edu, friedrich.schuening@Vanderbilt.Edu

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 1

  • 2 * 2 * 2 factorial design

Protocol 2

P with GCSF BM Control
IM Per Im Per  
N N N

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
Topic revision: r3 - 18 Dec 2005, FrankHarrell
 

This site is powered by FoswikiCopyright © 2013-2017 by the contributing authors. All material on this collaboration platform is the property of the contributing authors.
Ideas, requests, problems regarding Vanderbilt Biostatistics Wiki? Send feedback