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

Bharath Ambale Venkatesh, Victor Nauffal, Chikara Noda, Tomoki Fujii, Phillip C. Yang, Judy Bettencourt, Erin P. Ricketts, Michael Murphy, Nicholas J. Leeper, Lem Moyé, Ray F. Ebert, Raja Muthupillai, David A. Bluemke, Emerson C. Perin, Alan T. Hirsch, João A C Lima

Research output: Research - peer-reviewArticle

Abstract

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 13.5 mL/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.

LanguageEnglish (US)
Pages24-34
Number of pages11
JournalAmerican Heart Journal
Volume183
DOIs
StatePublished - Jan 1 2017

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Intermittent Claudication
Peripheral Arterial Disease
Cell- and Tissue-Based Therapy
Anatomy
Skeletal Muscle
Perfusion
Research
Magnetic Resonance Imaging
Muscles
Plasma Volume
Healthy Volunteers
Stem Cells
Therapeutics
Controlled Clinical Trials
Magnetic Resonance Spectroscopy
Public Health
Biomarkers
Bone Marrow
Placebos
Morbidity

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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. / 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.

In: American Heart Journal, Vol. 183, 01.01.2017, p. 24-34.

Research output: Research - peer-reviewArticle

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. / 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. In: American Heart Journal. 2017 ; Vol. 183. pp. 24-34
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abstract = "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 13.5 mL/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.",
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AU - Noda,Chikara

AU - Fujii,Tomoki

AU - Yang,Phillip C.

AU - Bettencourt,Judy

AU - Ricketts,Erin P.

AU - Murphy,Michael

AU - Leeper,Nicholas J.

AU - Moyé,Lem

AU - Ebert,Ray F.

AU - Muthupillai,Raja

AU - Bluemke,David A.

AU - Perin,Emerson C.

AU - Hirsch,Alan T.

AU - Lima,João A C

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N2 - 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 13.5 mL/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.

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