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Effects of alogliptin on fractional flow reserve evaluated by coronary computed tomography angiography in patients with type 2 diabetes: Rationale and design of the TRACT study

Abstract Background Patients with type 2 diabetes are at high risk for developing coronary artery disease (CAD). Noninvasive anatomic assessment by coronary computed tomography angiography (CCTA) is being increasingly used for detecting or excluding CAD. Recently, fractional flow reserve (FFR) using...

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Published in:Journal of cardiology 2017-03, Vol.69 (3), p.518-522
Main Authors: Nozue, Tsuyoshi, MD, Fukui, Kazuki, MD, Takamura, Takeshi, MD, Sozu, Takashi, PhD, Hibi, Kiyoshi, MD, FJCC, Kishi, Satoru, MD, Michishita, Ichiro, MD, FJCC
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creator Nozue, Tsuyoshi, MD
Fukui, Kazuki, MD
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description Abstract Background Patients with type 2 diabetes are at high risk for developing coronary artery disease (CAD). Noninvasive anatomic assessment by coronary computed tomography angiography (CCTA) is being increasingly used for detecting or excluding CAD. Recently, fractional flow reserve (FFR) using routinely acquired CCTA datasets (FFRCT ) has been developed. Although intensive glycemic control can reduce the risk of microvascular complications, intensive glucose control does not seem to be beneficial in preventing major cardiovascular events when compared with standard therapy. However, it has been reported that dipeptidyl peptidase-4 (DPP-4) inhibitors have anti-atherogenic effects in an animal model. In addition, DPP-4 inhibitors attenuate the progression of carotid intima-media thickness in patients with type 2 diabetes. Therefore, this study will be performed to evaluate the effects of alogliptin, a DPP-4 inhibitor, on coronary atherosclerosis using FFRCT in patients with type 2 diabetes. Methods and design This study will be a prospective, non-randomized, multicenter trial performed in Japan. Patients with type 2 diabetes who have intermediate coronary artery stenosis (diameter stenosis
doi_str_mv 10.1016/j.jjcc.2016.04.014
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Noninvasive anatomic assessment by coronary computed tomography angiography (CCTA) is being increasingly used for detecting or excluding CAD. Recently, fractional flow reserve (FFR) using routinely acquired CCTA datasets (FFRCT ) has been developed. Although intensive glycemic control can reduce the risk of microvascular complications, intensive glucose control does not seem to be beneficial in preventing major cardiovascular events when compared with standard therapy. However, it has been reported that dipeptidyl peptidase-4 (DPP-4) inhibitors have anti-atherogenic effects in an animal model. In addition, DPP-4 inhibitors attenuate the progression of carotid intima-media thickness in patients with type 2 diabetes. Therefore, this study will be performed to evaluate the effects of alogliptin, a DPP-4 inhibitor, on coronary atherosclerosis using FFRCT in patients with type 2 diabetes. Methods and design This study will be a prospective, non-randomized, multicenter trial performed in Japan. Patients with type 2 diabetes who have intermediate coronary artery stenosis (diameter stenosis &lt;70%) as evaluated by CCTA will be treated with 25 mg/day of alogliptin. After 48 weeks’ treatment, CCTA will be repeated. The primary endpoint will be changes in FFRCT , and the secondary endpoint will be the change in plaque volume from baseline to the 48-week follow-up. Conclusion This study will be the first multicenter trial to evaluate the effects of alogliptin on coronary atherosclerosis using the newly developed FFRCT as the primary endpoint, and the findings will clarify the anti-atherogenic effects of alogliptin.</description><identifier>ISSN: 0914-5087</identifier><identifier>EISSN: 1876-4738</identifier><identifier>DOI: 10.1016/j.jjcc.2016.04.014</identifier><identifier>PMID: 27236239</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Aged ; Alogliptin ; Cardiovascular ; Carotid Intima-Media Thickness ; Computed Tomography Angiography ; Coronary Angiography - methods ; Coronary atherosclerosis ; Coronary computed tomography angiography ; Coronary Stenosis - drug therapy ; Coronary Stenosis - physiopathology ; Diabetes Mellitus, Type 2 - complications ; Diabetes Mellitus, Type 2 - diagnostic imaging ; Dipeptidyl peptidase-4 inhibitor ; Dipeptidyl-Peptidase IV Inhibitors - therapeutic use ; Female ; Fractional flow reserve ; Fractional Flow Reserve, Myocardial - drug effects ; Humans ; Hypoglycemic Agents - therapeutic use ; Japan ; Male ; Middle Aged ; Piperidines - therapeutic use ; Plaque, Atherosclerotic - drug therapy ; Prospective Studies ; Uracil - analogs &amp; derivatives ; Uracil - therapeutic use</subject><ispartof>Journal of cardiology, 2017-03, Vol.69 (3), p.518-522</ispartof><rights>Japanese College of Cardiology</rights><rights>2016 Japanese College of Cardiology</rights><rights>Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c479t-ab93379b6ccfd73ac19c347870b413513142e0450748cc2449ac2bb86fc278113</citedby><cites>FETCH-LOGICAL-c479t-ab93379b6ccfd73ac19c347870b413513142e0450748cc2449ac2bb86fc278113</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27236239$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nozue, Tsuyoshi, MD</creatorcontrib><creatorcontrib>Fukui, Kazuki, MD</creatorcontrib><creatorcontrib>Takamura, Takeshi, MD</creatorcontrib><creatorcontrib>Sozu, Takashi, PhD</creatorcontrib><creatorcontrib>Hibi, Kiyoshi, MD, FJCC</creatorcontrib><creatorcontrib>Kishi, Satoru, MD</creatorcontrib><creatorcontrib>Michishita, Ichiro, MD, FJCC</creatorcontrib><title>Effects of alogliptin on fractional flow reserve evaluated by coronary computed tomography angiography in patients with type 2 diabetes: Rationale and design of the TRACT study</title><title>Journal of cardiology</title><addtitle>J Cardiol</addtitle><description>Abstract Background Patients with type 2 diabetes are at high risk for developing coronary artery disease (CAD). Noninvasive anatomic assessment by coronary computed tomography angiography (CCTA) is being increasingly used for detecting or excluding CAD. Recently, fractional flow reserve (FFR) using routinely acquired CCTA datasets (FFRCT ) has been developed. Although intensive glycemic control can reduce the risk of microvascular complications, intensive glucose control does not seem to be beneficial in preventing major cardiovascular events when compared with standard therapy. However, it has been reported that dipeptidyl peptidase-4 (DPP-4) inhibitors have anti-atherogenic effects in an animal model. In addition, DPP-4 inhibitors attenuate the progression of carotid intima-media thickness in patients with type 2 diabetes. Therefore, this study will be performed to evaluate the effects of alogliptin, a DPP-4 inhibitor, on coronary atherosclerosis using FFRCT in patients with type 2 diabetes. Methods and design This study will be a prospective, non-randomized, multicenter trial performed in Japan. Patients with type 2 diabetes who have intermediate coronary artery stenosis (diameter stenosis &lt;70%) as evaluated by CCTA will be treated with 25 mg/day of alogliptin. After 48 weeks’ treatment, CCTA will be repeated. The primary endpoint will be changes in FFRCT , and the secondary endpoint will be the change in plaque volume from baseline to the 48-week follow-up. 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derivatives</topic><topic>Uracil - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nozue, Tsuyoshi, MD</creatorcontrib><creatorcontrib>Fukui, Kazuki, MD</creatorcontrib><creatorcontrib>Takamura, Takeshi, MD</creatorcontrib><creatorcontrib>Sozu, Takashi, PhD</creatorcontrib><creatorcontrib>Hibi, Kiyoshi, MD, FJCC</creatorcontrib><creatorcontrib>Kishi, Satoru, MD</creatorcontrib><creatorcontrib>Michishita, Ichiro, MD, FJCC</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nozue, Tsuyoshi, MD</au><au>Fukui, Kazuki, MD</au><au>Takamura, Takeshi, MD</au><au>Sozu, Takashi, PhD</au><au>Hibi, Kiyoshi, MD, FJCC</au><au>Kishi, Satoru, MD</au><au>Michishita, Ichiro, MD, FJCC</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of alogliptin on fractional flow reserve evaluated by coronary computed tomography angiography in patients with type 2 diabetes: Rationale and design of the TRACT study</atitle><jtitle>Journal of cardiology</jtitle><addtitle>J Cardiol</addtitle><date>2017-03-01</date><risdate>2017</risdate><volume>69</volume><issue>3</issue><spage>518</spage><epage>522</epage><pages>518-522</pages><issn>0914-5087</issn><eissn>1876-4738</eissn><abstract>Abstract Background Patients with type 2 diabetes are at high risk for developing coronary artery disease (CAD). Noninvasive anatomic assessment by coronary computed tomography angiography (CCTA) is being increasingly used for detecting or excluding CAD. Recently, fractional flow reserve (FFR) using routinely acquired CCTA datasets (FFRCT ) has been developed. Although intensive glycemic control can reduce the risk of microvascular complications, intensive glucose control does not seem to be beneficial in preventing major cardiovascular events when compared with standard therapy. However, it has been reported that dipeptidyl peptidase-4 (DPP-4) inhibitors have anti-atherogenic effects in an animal model. In addition, DPP-4 inhibitors attenuate the progression of carotid intima-media thickness in patients with type 2 diabetes. Therefore, this study will be performed to evaluate the effects of alogliptin, a DPP-4 inhibitor, on coronary atherosclerosis using FFRCT in patients with type 2 diabetes. Methods and design This study will be a prospective, non-randomized, multicenter trial performed in Japan. Patients with type 2 diabetes who have intermediate coronary artery stenosis (diameter stenosis &lt;70%) as evaluated by CCTA will be treated with 25 mg/day of alogliptin. After 48 weeks’ treatment, CCTA will be repeated. The primary endpoint will be changes in FFRCT , and the secondary endpoint will be the change in plaque volume from baseline to the 48-week follow-up. Conclusion This study will be the first multicenter trial to evaluate the effects of alogliptin on coronary atherosclerosis using the newly developed FFRCT as the primary endpoint, and the findings will clarify the anti-atherogenic effects of alogliptin.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>27236239</pmid><doi>10.1016/j.jjcc.2016.04.014</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record>
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subjects Aged
Alogliptin
Cardiovascular
Carotid Intima-Media Thickness
Computed Tomography Angiography
Coronary Angiography - methods
Coronary atherosclerosis
Coronary computed tomography angiography
Coronary Stenosis - drug therapy
Coronary Stenosis - physiopathology
Diabetes Mellitus, Type 2 - complications
Diabetes Mellitus, Type 2 - diagnostic imaging
Dipeptidyl peptidase-4 inhibitor
Dipeptidyl-Peptidase IV Inhibitors - therapeutic use
Female
Fractional flow reserve
Fractional Flow Reserve, Myocardial - drug effects
Humans
Hypoglycemic Agents - therapeutic use
Japan
Male
Middle Aged
Piperidines - therapeutic use
Plaque, Atherosclerotic - drug therapy
Prospective Studies
Uracil - analogs & derivatives
Uracil - therapeutic use
title Effects of alogliptin on fractional flow reserve evaluated by coronary computed tomography angiography in patients with type 2 diabetes: Rationale and design of the TRACT study
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