CAuSMIC, 2005 trial summary    PDF 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

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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 sizes12 / 11



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



EndpointX1N1X0N0TE95% CI NYHA deterioration 0 12 6 11 Out of scale0,07[0,00; 1,53] LVEF - -9 - -9 no data Peak VO2 (mL/kg/min) - -9 - -9 no data acute heart failure - -9 - -9 no data cardiac event - 12 - 11 no data NYHA class - -9 - -9 no data LV End-Systolic Volume - -9 - -9 no data Minnesota Living With Heart Failure Questionnaire - 12 - 11 no data ventricular tachycardia 2 12 1 11 1,53[0,17; 14,00] 6-min Walk, m - -9 - -9 no data NT-proBNP - -9 - -9 no data all-cause mortality - -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   add to Mendeley  

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   add to Mendeley  



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