Baseline assessment and comparison of arterial anatomy, hyperemic flow, and skeletal muscle perfusion in peripheral artery disease: The Cardiovascular Cell Therapy Research Network “Patients with Intermittent Claudication Injected with ALDH Bright Cells” (CCTRN PACE) study

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 pro...

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Bibliographic Details
Published in:The American heart journal 2017-01, Vol.183, p.24-34
Main Authors: Venkatesh, Bharath Ambale, Nauffal, Victor, Noda, Chikara, Fujii, Tomoki, Yang, Phillip C., Bettencourt, Judy, Ricketts, Erin P., Murphy, Michael, Leeper, Nicholas J., Moyé, Lem, Ebert, Ray F., Muthupillai, Raja, Bluemke, David A., Perin, Emerson C., Hirsch, Alan T., Lima, João A.C.
Format: Article
Language:English
Subjects:
Anatomy & physiology
Autografts
Clinical trials
Double-Blind Method
Female
Health care
Heart
Hematopoietic Stem Cell Transplantation
Humans
Injections, Intramuscular
Intermittent Claudication - physiopathology
Intermittent Claudication - therapy
Leg - blood supply
Leg - diagnostic imaging
Magnetic Resonance Angiography
Magnetic Resonance Imaging
Male
Medical imaging
Muscle, Skeletal - blood supply
Musculoskeletal system
NMR
Nuclear magnetic resonance
Peripheral Arterial Disease - physiopathology
Peripheral Arterial Disease - therapy
Regional Blood Flow
Scanners
Stem cells
Studies
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Summary: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. 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). 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. 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.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2016.09.013