CAuSMIC, 2005 trial summary

A randomised clinical trial investigating the effect of myoblasts versus control in patients with previous myocardial infarction and heart failure, New York Heart Association (NYHA) functional class II to IV

JACC Cardiovasc Interv 2009;2:9-16  




Studied treatment 3-dimensional guided catheter-based delivery of autologous skeletal myoblasts
Control treatment control
cell type Skeletal myoblasts
Cell injection procedure Endomyocardial



Patients patients with previous myocardial infarction and heart failure, New York Heart Association (NYHA) functional class II to IV
Group sizes 12 / 11



Blindness Inclusion period
Follow-up duration 12 mo Centers
Lost to FU geographical localisation
Primary endpoint Design



EndpointX1N1X0N0TE95% CI acute heart failure - -9 - -9 no data LV End-Systolic Volume - -9 - -9 no data ventricular tachycardia 2 12 1 11 1,83[0,14; 23,61] NT-proBNP - -9 - -9 no data NYHA deterioration 0 12 6 11 Out of scale0,07[0,00; 1,53] Peak VO2 (mL/kg/min) - -9 - -9 no data NYHA class - -9 - -9 no data cardiac event - 12 - 11 no data Minnesota Living With Heart Failure Questionnaire - 12 - 11 no data 6-min Walk, m - -9 - -9 no data all-cause mortality - -9 - -9 no data LVEF - -9 - -9 no data0,22,01,0


Dib N, Michler RE, Pagani FD, Wright S, Kereiakes DJ, Lengerich R, Binkley P, Buchele D, Anand I, Swingen C, Di Carli MF, Thomas JD, Jaber WA, Opie SR, Campbell A, McCarthy P, Yeager M, Dilsizian V, Griffith BP, Korn R, Kreuger SK, Ghazoul M, MacLellan WR Safety and feasibility of autologous myoblast transplantation in patients with ischemic cardiomyopathy: four-year follow-up. Circulation 2005;112:1748-55     [PMID: 16172284]   link to pdf  

Dib N, Dinsmore J, Lababidi Z, White B, Moravec S, Campbell A, Rosenbaum A, Seyedmadani K, Jaber WA, Rizenhour CS, Diethrich E One-year follow-up of feasibility and safety of the first U.S., randomized, controlled study using 3-dimensional guided catheter-based delivery of autologous skeletal myoblasts for ischemic cardiomyopathy (CAuSMIC study). JACC Cardiovasc Interv 2009;2:9-16     [PMID: 19463392]   link to pdf  



Registering number (see trial on clinicaltrials.gov)
Code Name

 




Appears in following systematic reviews: