BACKGROUND:Peripheral artery disease (PAD) is important to public health as a major contributor to cardiovascular morbidity and mortality. Recent developments in magnetic resonance imaging (MRI) techniques permit improved assessment of PAD anatomy and physiology, and may serve as surrogate end points after proangiogenic therapies. METHODS: The PACE study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the physiologic impact and potential clinical efficacy of autologous bone marrow-derived ALDHbr stem cells. The primary MRI end points of the study are as follows: (1) total collateral count, (2) calf muscle plasma volume (a measure of capillary perfusion) by dynamic contrast-enhanced MRI, and (3) peak hyperemic popliteal flow by phase-contrast MRI (PC-MRI). RESULTS: The interreader and intrareader and test-retest results demonstrated good-to-excellent reproducibility (interclass correlation coefficient range 0.61-0.98) for all magnetic resonance measures. The PAD participants (n=82) had lower capillary perfusion measured by calf muscle plasma volume (3.8% vs 5.6%) and peak hyperemic popliteal flow (4.1 vs 13.5mL/s) as compared with the healthy participants (n=16), with a significant level of collateralization. CONCLUSIONS: Reproducibility of the MRI primary end points in PACE was very good to excellent. The PAD participants exhibited decreased calf muscle capillary perfusion as well as arterial flow reserve when compared with healthy participants. The MRI tools used in PACE may advance PAD science by enabling accurate measurement of PAD microvascular anatomy and perfusion before and after stem cell or other PAD therapies.
RCT Entities:
BACKGROUND:Peripheral artery disease (PAD) is important to public health as a major contributor to cardiovascular morbidity and mortality. Recent developments in magnetic resonance imaging (MRI) techniques permit improved assessment of PAD anatomy and physiology, and may serve as surrogate end points after proangiogenic therapies. METHODS: The PACE study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the physiologic impact and potential clinical efficacy of autologous bone marrow-derived ALDHbr stem cells. The primary MRI end points of the study are as follows: (1) total collateral count, (2) calf muscle plasma volume (a measure of capillary perfusion) by dynamic contrast-enhanced MRI, and (3) peak hyperemic popliteal flow by phase-contrast MRI (PC-MRI). RESULTS: The interreader and intrareader and test-retest results demonstrated good-to-excellent reproducibility (interclass correlation coefficient range 0.61-0.98) for all magnetic resonance measures. The PAD participants (n=82) had lower capillary perfusion measured by calf muscle plasma volume (3.8% vs 5.6%) and peak hyperemic popliteal flow (4.1 vs 13.5mL/s) as compared with the healthy participants (n=16), with a significant level of collateralization. CONCLUSIONS: Reproducibility of the MRI primary end points in PACE was very good to excellent. The PAD participants exhibited decreased calf muscle capillary perfusion as well as arterial flow reserve when compared with healthy participants. The MRI tools used in PACE may advance PAD science by enabling accurate measurement of PAD microvascular anatomy and perfusion before and after stem cell or other PAD therapies.
Authors: Karolien Jaspers; Tim Leiner; Petra Dijkstra; Marlies Oostendorp; Jolanda M van Golde; Mark J Post; Walter H Backes Journal: Med Phys Date: 2010-11 Impact factor: 4.071
Authors: Emerson C Perin; Michael Murphy; John P Cooke; Lem Moyé; Timothy D Henry; Judy Bettencourt; Amir Gahremanpour; Nicholas Leeper; R David Anderson; William R Hiatt; Joao A Lima; Bharath Venkatesh; Shelly L Sayre; Rachel W Vojvodic; Doris A Taylor; Ray F Ebert; Alan T Hirsch Journal: Am Heart J Date: 2014-07-30 Impact factor: 4.749
Authors: F Gerald R Fowkes; Diana Rudan; Igor Rudan; Victor Aboyans; Julie O Denenberg; Mary M McDermott; Paul E Norman; Uchechukwe K A Sampson; Linda J Williams; George A Mensah; Michael H Criqui Journal: Lancet Date: 2013-08-01 Impact factor: 79.321
Authors: Jan Hansmann; Henrik J Michaely; John N Morelli; Steffen J Diehl; Mathias Meyer; Stefan O Schoenberg; Ulrike I Attenberger Journal: AJR Am J Roentgenol Date: 2013-12 Impact factor: 3.959
Authors: Xiaowan Li; Christopher C Conlin; Stephen T Decker; Nan Hu; Michelle Mueller; Lillian Khor; Christopher Hanrahan; Gwenael Layec; Vivian S Lee; Jeff L Zhang Journal: Magn Reson Imaging Date: 2018-11-22 Impact factor: 2.546
Authors: Emerson C Perin; Michael P Murphy; Keith L March; Roberto Bolli; John Loughran; Phillip C Yang; Nicholas J Leeper; Ronald L Dalman; Jason Alexander; Timothy D Henry; Jay H Traverse; Carl J Pepine; R David Anderson; Scott Berceli; James T Willerson; Raja Muthupillai; Amir Gahremanpour; Ganesh Raveendran; Omaida Velasquez; Joshua M Hare; Ivonne Hernandez Schulman; Vijaykumar S Kasi; William R Hiatt; Bharath Ambale-Venkatesh; João A Lima; Doris A Taylor; Micheline Resende; Adrian P Gee; April G Durett; Jeanette Bloom; Sara Richman; Patricia G'Sell; Shari Williams; Fouzia Khan; Elsie Gyang Ross; Michelle R Santoso; JoAnne Goldman; Dana Leach; Eileen Handberg; Benjamin Cheong; Nichole Piece; Darcy DiFede; Barb Bruhn-Ding; Emily Caldwell; Judy Bettencourt; Dejian Lai; Linda Piller; Lara Simpson; Michelle Cohen; Shelly L Sayre; Rachel W Vojvodic; Lem Moyé; Ray F Ebert; Robert D Simari; Alan T Hirsch Journal: Circulation Date: 2017-02-16 Impact factor: 29.690