Abdominal Aortic Calcium and CAD-RADS 2.0

NCT06956924 | Completed

• 2 other identifiers: liao1009_01CMRPG8L0731
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Abdominal aortic calcium (AAC) is a marker of systemic atherosclerosis and may predict cardiovascular outcomes similarly to coronary artery calcium (CAC). This study evaluates the predictive efficacy of CT-based AAC scores for coronary plaque burden and stenosis using the CAD-RADS 2.0 classification system. Methods: A prospective cohort of 68 patients (mean age 67.5 years) with chest pain underwent cardiac CT for CAC, AAC scoring, and coronary computed tomography angiography (CCTA) at Kaohsiung Chang Gung Memorial Hospital (June 2021-May 2023). AAC scores were quantified using the Agatston method across 8 cm and 5 cm aortic segments, and outcomes were analyzed based on CAD-RADS 2.0 and plaque burden classifications.

Conditions

Coronary Artery Disease (CAD)

Keywords

Coronary Artery Disease (CAD); Abdominal Aortic Calcium (AAC); Coronary Artery Calcium (CAC); CAD-RADS 2.0 Classification; Coronary Plaque Burden

Outcome Measures

Primary Outcomes (1)

• Image Analysis

  The CAD-RADS 2.0 classification system was used to assess the severity of coronary stenosis across five distinct categories: CAD-RADS 0 (no visible stenosis, 0% maximal coronary stenosis), CAD-RADS 1 (minimal stenosis, 1-24%), CAD-RADS 2 (mild stenosis, 25-49%), CAD-RADS 3 (moderate stenosis, 50-69%), CAD-RADS 4 (severe stenosis, subdivided into 4A \[70-99%\] and 4B \[left main \>50% or three-vessel obstructive disease\]), and CAD-RADS 5 (100% occlusion). The outcome measures in this study were categorized based on the 2022 Coronary Artery Disease-Reporting and Data System (CAD-RADS), which classifies coronary artery stenosis and plaque burden into distinct categories without the use of specific measurement units. Coronary artery stenosis was graded using a numeric scale from 0 to 5, with higher numbers indicating greater severity of stenosis. Plaque volume was categorized using a classification system ranging from P1 to P4, with P4 representing the highest plaque burden.

  From enrollment to the end of treatment at 1 week

Study Arms (1)

CCTA and Non-Enhanced Abdominal CT Scan Protocol

EXPERIMENTAL

CCTA was performed using a 640-slice multislice CT scanner (Canon Aquilion One Genesis, Canon Medical Systems, Japan). All participants received sublingual nitroglycerin (0.3 mg) to promote coronary vasodilation prior to imaging. The first phase involved an unenhanced, prospective electrocardiogram (ECG)-gated volume scan for CAC assessment, configured to 120 kVp and 50 mAs with a field of view (FOV) of 16 cm to ensure comprehensive cardiac coverage. Imaging was performed with a rotation time of 0.275 seconds and a slice thickness of 2 mm. Following this, an abdominal aorta scan was performed using a non-ECG-gated sequential scan mode, maintaining identical settings of 120 kVp and 2 mm slice thickness. The inferior aspect of the L5 vertebral body endplate was used as the caudal extent of the abdominal volume to be imaged, covering the iliac bifurcation of the infrarenal abdominal aorta while minimizing radiation exposure to the pelvic genital organs.

Diagnostic Test: CCTA

Interventions

CCTA DIAGNOSTIC_TEST

The data acquisition protocol was tailored to each patient's heart rate and rhythm. Specifically, a prospectively ECG-triggered volume scan was used to account for heart rates and rhythms, capturing predefined scanning areas during R-R intervals, especially in instances of frequent ectopic beats or irregular heart rates noted during pre-scan ECG monitoring. Imaging system parameters included a gantry rotation time of 0.275 seconds, collimation of 0.5 mm, tube voltage settings ranging from 100 kV to 120 kV, and a tube current-time product between 200 mAs and 450 mAs, with adjustments based on the patient's BMI.

CCTA and Non-Enhanced Abdominal CT Scan Protocol

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with chest pain or discomfort who were scheduled to undergo cardiac CT for CAC and CCTA
• determined by the treating physician for the evaluation of CAD

You may not qualify if:

• severe allergies to contrast agents
• metallic implants in the lumbar spine
• renal function abnormalities (estimated glomerular filtration rate \[eGFR\] \< 60)
• abdominal aortic aneurysms
• prior coronary artery stent placements or bypass surgery

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan

Kaohsiung City, Niao Sung, 833, Taiwan

Location

Related Publications (31)

• Takayama Y, Yasuda Y, Suzuki S, Shibata Y, Tatami Y, Shibata K, Niwa M, Sawai A, Morimoto R, Kato S, Ishii H, Maruyama S, Murohara T. Relationship between abdominal aortic and coronary artery calcification as detected by computed tomography in chronic kidney disease patients. Heart Vessels. 2016 Jul;31(7):1030-7. doi: 10.1007/s00380-015-0712-y. Epub 2015 Jul 12.

  PMID: 26164596 BACKGROUND

• Briet M, Burns KD. Chronic kidney disease and vascular remodelling: molecular mechanisms and clinical implications. Clin Sci (Lond). 2012 Oct;123(7):399-416. doi: 10.1042/CS20120074.

  PMID: 22671427 BACKGROUND

• van Rosendael AR, van den Hoogen IJ, Gianni U, Ma X, Tantawy SW, Bax AM, Lu Y, Andreini D, Al-Mallah MH, Budoff MJ, Cademartiri F, Chinnaiyan K, Choi JH, Conte E, Marques H, de Araujo Goncalves P, Gottlieb I, Hadamitzky M, Leipsic JA, Maffei E, Pontone G, Shin S, Kim YJ, Lee BK, Chun EJ, Sung JM, Lee SE, Virmani R, Samady H, Sato Y, Stone PH, Berman DS, Narula J, Blankstein R, Min JK, Lin FY, Shaw LJ, Bax JJ, Chang HJ. Association of Statin Treatment With Progression of Coronary Atherosclerotic Plaque Composition. JAMA Cardiol. 2021 Nov 1;6(11):1257-1266. doi: 10.1001/jamacardio.2021.3055.

  PMID: 34406326 BACKGROUND

• Schousboe JT, Claflin D, Barrett-Connor E. Association of coronary aortic calcium with abdominal aortic calcium detected on lateral dual energy x-ray absorptiometry spine images. Am J Cardiol. 2009 Aug 1;104(3):299-304. doi: 10.1016/j.amjcard.2009.03.041. Epub 2009 Jun 6.

  PMID: 19616658 BACKGROUND

• Williams MC, Earls JP, Hecht H. Quantitative assessment of atherosclerotic plaque, recent progress and current limitations. J Cardiovasc Comput Tomogr. 2022 Mar-Apr;16(2):124-137. doi: 10.1016/j.jcct.2021.07.001. Epub 2021 Jul 16.

  PMID: 34326003 BACKGROUND

• Min JK, Shaw LJ, Devereux RB, Okin PM, Weinsaft JW, Russo DJ, Lippolis NJ, Berman DS, Callister TQ. Prognostic value of multidetector coronary computed tomographic angiography for prediction of all-cause mortality. J Am Coll Cardiol. 2007 Sep 18;50(12):1161-70. doi: 10.1016/j.jacc.2007.03.067. Epub 2007 Sep 4.

  PMID: 17868808 BACKGROUND

• Williams MC, Newby DE, Dey D, Dweck MR. Response by Williams et al to Letter Regarding Article, "Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Results From the Multicenter SCOT-HEART Trial (Scottish Computed Tomography of the HEART)". Circulation. 2020 Oct 20;142(16):e244-e245. doi: 10.1161/CIRCULATIONAHA.120.049840. Epub 2020 Oct 19. No abstract available.

  PMID: 33074760 BACKGROUND

• Sama C, Abdelhaleem A, Velu D, Ditah Chobufo M, Fongwen NT, Budoff MJ, Roberts M, Balla S, Mills JD, Njim TN, Greathouse M, Zeb I, Hamirani YS. Non-calcified plaque in asymptomatic patients with zero coronary artery calcium score: A systematic review and meta-analysis. J Cardiovasc Comput Tomogr. 2024 Jan-Feb;18(1):43-49. doi: 10.1016/j.jcct.2023.10.002. Epub 2023 Oct 9.

  PMID: 37821352 BACKGROUND

• Devia-Rodriguez R, Derksen M, de Groot K, Vedder IR, Zeebregts CJ, Bokkers RPH, Pol RA, de Vries JPM, Schuurmann RCL. Validation of a Length-Adjusted Abdominal Arterial Calcium Score Method for Contrast-Enhanced CT Scans. Diagnostics (Basel). 2023 Jun 1;13(11):1934. doi: 10.3390/diagnostics13111934.

  PMID: 37296786 BACKGROUND

• Mori S, Takaya T, Kinugasa M, Ito T, Takamine S, Fujiwara S, Nishii T, Kono AK, Inoue T, Satomi-Kobayashi S, Rikitake Y, Okita Y, Hirata K. Three-dimensional quantification and visualization of aortic calcification by multidetector-row computed tomography: a simple approach using a volume-rendering method. Atherosclerosis. 2015 Apr;239(2):622-8. doi: 10.1016/j.atherosclerosis.2014.12.041. Epub 2014 Dec 24.

  PMID: 25554696 BACKGROUND

• Oishi H, Horibe H, Yamase Y, Ueyama C, Takemoto Y, Shigeta T, Hibino T, Kondo T, Suzuki S, Ishii H, Murohara T. Predictive value of abdominal aortic calcification index for mid-term cardiovascular events in patients with acute coronary syndrome. Heart Vessels. 2020 May;35(5):620-629. doi: 10.1007/s00380-019-01527-6. Epub 2019 Nov 9.

  PMID: 31707516 BACKGROUND

• Chuang ML, Leslie RW, Massaro JM, Manders ES, Fox CS, Hoffmann U, O'Donnell CJ. Distribution of abdominal aortic calcium by computed tomography: impact of analysis method on quantitative calcium score. Acad Radiol. 2013 Nov;20(11):1422-8. doi: 10.1016/j.acra.2013.08.008.

  PMID: 24119355 BACKGROUND

• Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol. 1990 Mar 15;15(4):827-32. doi: 10.1016/0735-1097(90)90282-t.

  PMID: 2407762 BACKGROUND

• Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.

  PMID: 30586774 BACKGROUND

• Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PW, Jordan HS, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S49-73. doi: 10.1161/01.cir.0000437741.48606.98. Epub 2013 Nov 12. No abstract available.

  PMID: 24222018 BACKGROUND

• O'Connor SD, Graffy PM, Zea R, Pickhardt PJ. Does Nonenhanced CT-based Quantification of Abdominal Aortic Calcification Outperform the Framingham Risk Score in Predicting Cardiovascular Events in Asymptomatic Adults? Radiology. 2019 Jan;290(1):108-115. doi: 10.1148/radiol.2018180562. Epub 2018 Oct 2.

  PMID: 30277443 BACKGROUND

• Bastos Goncalves F, Voute MT, Hoeks SE, Chonchol MB, Boersma EE, Stolker RJ, Verhagen HJ. Calcification of the abdominal aorta as an independent predictor of cardiovascular events: a meta-analysis. Heart. 2012 Jul;98(13):988-94. doi: 10.1136/heartjnl-2011-301464.

  PMID: 22668866 BACKGROUND

• Skalsky K, Shiyovich A, Hochwald N, Levi A, Zreik L, Tamir S, Shafir G, Briger A, Rahamimov R, Kornowski R, Hamdan A. Coronary Computed Tomography Angiography and Abdominal Aortic Calcification Screening among High-Risk Living Kidney Donors. J Clin Med. 2023 Jul 7;12(13):4541. doi: 10.3390/jcm12134541.

  PMID: 37445576 BACKGROUND

• Cury RC, Leipsic J, Abbara S, Achenbach S, Berman D, Bittencourt M, Budoff M, Chinnaiyan K, Choi AD, Ghoshhajra B, Jacobs J, Koweek L, Lesser J, Maroules C, Rubin GD, Rybicki FJ, Shaw LJ, Williams MC, Williamson E, White CS, Villines TC, Blankstein R. CAD-RADS 2.0 - 2022 Coronary Artery Disease-Reporting and Data System: An Expert Consensus Document of the Society of Cardiovascular Computed Tomography (SCCT), the American College of Cardiology (ACC), the American College of Radiology (ACR), and the North America Society of Cardiovascular Imaging (NASCI). J Cardiovasc Comput Tomogr. 2022 Nov-Dec;16(6):536-557. doi: 10.1016/j.jcct.2022.07.002. Epub 2022 Jul 8.

  PMID: 35864070 BACKGROUND

• Cury RC, Abbara S, Achenbach S, Agatston A, Berman DS, Budoff MJ, Dill KE, Jacobs JE, Maroules CD, Rubin GD, Rybicki FJ, Schoepf UJ, Shaw LJ, Stillman AE, White CS, Woodard PK, Leipsic JA. CAD-RADS: Coronary Artery Disease - Reporting and Data System: An Expert Consensus Document of the Society of Cardiovascular Computed Tomography (SCCT), the American College of Radiology (ACR) and the North American Society for Cardiovascular Imaging (NASCI). Endorsed by the American College of Cardiology. J Am Coll Radiol. 2016 Dec;13(12 Pt A):1458-1466.e9. doi: 10.1016/j.jacr.2016.04.024. Epub 2016 Jun 15.

  PMID: 27318576 BACKGROUND

• Versteylen MO, Kietselaer BL, Dagnelie PC, Joosen IA, Dedic A, Raaijmakers RH, Wildberger JE, Nieman K, Crijns HJ, Niessen WJ, Daemen MJ, Hofstra L. Additive value of semiautomated quantification of coronary artery disease using cardiac computed tomographic angiography to predict future acute coronary syndrome. J Am Coll Cardiol. 2013 Jun 4;61(22):2296-305. doi: 10.1016/j.jacc.2013.02.065. Epub 2013 Apr 3.

  PMID: 23562925 BACKGROUND

• Chang HJ, Lin FY, Gebow D, An HY, Andreini D, Bathina R, Baggiano A, Beltrama V, Cerci R, Choi EY, Choi JH, Choi SY, Chung N, Cole J, Doh JH, Ha SJ, Her AY, Kepka C, Kim JY, Kim JW, Kim SW, Kim W, Pontone G, Valeti U, Villines TC, Lu Y, Kumar A, Cho I, Danad I, Han D, Heo R, Lee SE, Lee JH, Park HB, Sung JM, Leflang D, Zullo J, Shaw LJ, Min JK. Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CAD: A Randomized, Controlled, Open-Label Trial. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 2):1303-1312. doi: 10.1016/j.jcmg.2018.09.018. Epub 2018 Dec 12.

  PMID: 30553687 BACKGROUND

• Mowatt G, Cummins E, Waugh N, Walker S, Cook J, Jia X, Hillis GS, Fraser C. Systematic review of the clinical effectiveness and cost-effectiveness of 64-slice or higher computed tomography angiography as an alternative to invasive coronary angiography in the investigation of coronary artery disease. Health Technol Assess. 2008 May;12(17):iii-iv, ix-143. doi: 10.3310/hta12170.

  PMID: 18462576 BACKGROUND

• Ferencik M, Mayrhofer T, Puchner SB, Lu MT, Maurovich-Horvat P, Liu T, Ghemigian K, Kitslaar P, Broersen A, Bamberg F, Truong QA, Schlett CL, Hoffmann U. Computed tomography-based high-risk coronary plaque score to predict acute coronary syndrome among patients with acute chest pain--Results from the ROMICAT II trial. J Cardiovasc Comput Tomogr. 2015 Nov-Dec;9(6):538-45. doi: 10.1016/j.jcct.2015.07.003. Epub 2015 Jul 10.

  PMID: 26229036 BACKGROUND

• Motoyama S, Sarai M, Harigaya H, Anno H, Inoue K, Hara T, Naruse H, Ishii J, Hishida H, Wong ND, Virmani R, Kondo T, Ozaki Y, Narula J. Computed tomographic angiography characteristics of atherosclerotic plaques subsequently resulting in acute coronary syndrome. J Am Coll Cardiol. 2009 Jun 30;54(1):49-57. doi: 10.1016/j.jacc.2009.02.068.

  PMID: 19555840 BACKGROUND

• Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36. doi: 10.1056/NEJMoa0806576.

  PMID: 19038879 BACKGROUND

• An C, Lee HJ, Lee HS, Ahn SS, Choi BW, Kim MJ, Chung YE. CT-based abdominal aortic calcification score as a surrogate marker for predicting the presence of asymptomatic coronary artery disease. Eur Radiol. 2014 Oct;24(10):2491-8. doi: 10.1007/s00330-014-3298-3. Epub 2014 Jul 17.

  PMID: 25030461 BACKGROUND

• Zweig BM, Sheth M, Simpson S, Al-Mallah MH. Association of abdominal aortic calcium with coronary artery calcium and obstructive coronary artery disease: a pilot study. Int J Cardiovasc Imaging. 2012 Feb;28(2):399-404. doi: 10.1007/s10554-011-9818-1. Epub 2011 Feb 24.

  PMID: 21347596 BACKGROUND

• Jurgens PT, Carr JJ, Terry JG, Rana JS, Jacobs DR Jr, Duprez DA. Association of Abdominal Aorta Calcium and Coronary Artery Calcium with Incident Cardiovascular and Coronary Heart Disease Events in Black and White Middle-Aged People: The Coronary Artery Risk Development in Young Adults Study. J Am Heart Assoc. 2021 Dec 21;10(24):e023037. doi: 10.1161/JAHA.121.023037. Epub 2021 Dec 7.

  PMID: 34873926 BACKGROUND

• Janjua SA, Massaro JM, Chuang ML, D'Agostino RB, Hoffmann U, O'Donnell CJ. Thresholds for Abdominal Aortic Calcium That Predict Cardiovascular Disease Events in the Framingham Heart Study. JACC Cardiovasc Imaging. 2021 Mar;14(3):695-697. doi: 10.1016/j.jcmg.2020.09.019. Epub 2020 Nov 18. No abstract available.

  PMID: 33221220 BACKGROUND

• Kauppila LI, Polak JF, Cupples LA, Hannan MT, Kiel DP, Wilson PW. New indices to classify location, severity and progression of calcific lesions in the abdominal aorta: a 25-year follow-up study. Atherosclerosis. 1997 Jul 25;132(2):245-50. doi: 10.1016/s0021-9150(97)00106-8.

  PMID: 9242971 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Chien-Chang Liao, M.D.

  Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 4, 2025
• Study Start: June 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

TW (1)