Coronary Heart DiseasePARADIGMNCT02803411
Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)
An observational study of Coronary Heart Disease, run by Yonsei University.
Trial summary
To describe the natural history of the coronary atherosclerotic plaque development and progression over time by CCTA with demographic and laboratory data for refinement of risk stratification of patients referred for CCTA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Jan 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population is patients with suspected or known CAD who had undergone serial CCTA by physician referral. Sites that had collected cohorts of CCTA patients with symptoms, risk factors, CCTA image data, and outcomes were invited to contribute data for a merged database. This sample includes patients with suspected or known CAD, and asymptomatic subjects undergoing CCTA for risk stratification to evaluate the significance of changes in CCTA findings in different clinical contexts.
Who may be able to join
- patients underwent two or more clinically indicated CCTA with 64-detector rows or greater for CAD evaluation
- patients underwent at least 2 year interval between the baseline and follow-up CCTA
Who cannot join
- poor image quality of CCTA
About this study
To describe the natural history of the coronary atherosclerotic plaque development and progression over time by CCTA with demographic and laboratory data for refinement of risk stratification of patients referred for CCTA.
Read the detailed description
All PARADIGM study patients underwent initial and follow-up CCTA based on order from their primary physician. Demographic data, targeted medical history, cardiovascular risk factors, and laboratory data was prospectively collected in electronic case report forms (eCRFs) at the time of the initial CCTA and at the time of follow-up CCTA.
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Heart Disease, Coronary Computed Tomography Angiography (CCTA), Coronary Atherosclerotic Plaque, coronary atherosclerosis
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plaque volume and composition detected by follow up CCTA
Measured: 2 years
Secondary outcomes (4)
Cardiac mortality (yes or no)
Measured: 2 years
Myocardial infarction (yes or no)
Measured: 2 years
Unstable angina requiring hospitalization (yes or no)
Measured: 2 years
Revascularization (yes or no)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startMar 2003
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal Heart Institute, Hospital da Luz, Portugal, University of California, Los Angeles, Centro Cardiologico Monzino, University of British Columbia, German Heart Institute, National Institute of Cardiology, Laranjeiras, Brazil, Weill Medical College of Cornell University, Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Hyuk-Jae Chang, Yonsei University
- Investigators
- Hyuk-Jae Chang, MD, PhD, Principal investigator, Yonsei Univerity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803411
- Sponsor's protocol ID
- 4-2016-0263
- Acronym
- PARADIGM
- Status last verified
- Jun 2018
- First submitted
- 3 Jun 2016
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee SE, Chang HJ, Rizvi A, Hadamitzky M, Kim YJ, Conte E, Andreini D, Pontone G, Volpato V, Budoff MJ, Gottlieb I, Lee BK, Chun EJ, Cademartiri F, Maffei E, Marques H, Leipsic JA, Shin S, Choi JH, Chung N, Min JK. Rationale and design of the Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography IMaging (PARADIGM) registry: A comprehensive exploration of plaque progression and its impact on clinical outcomes from a multicenter serial coronary computed tomographic angiography study. Am Heart J. 2016 Dec;182:72-79. doi: 10.1016/j.ahj.2016.09.003. Epub 2016 Sep 22.
PubMed 27914502Lee SE, Sung JM, Andreini D, Al-Mallah MH, Budoff MJ, Cademartiri F, Chinnaiyan K, Choi JH, Chun EJ, Conte E, Gottlieb I, Hadamitzky M, Kim YJ, Lee BK, Leipsic JA, Maffei E, Marques H, de Araujo Goncalves P, Pontone G, Stone PH, Virmani R, Narula J, Shaw LJ, Bax JJ, Lin FY, Min JK, Chang HJ. Patient-Level Perivascular Adipose Tissue Density Aggregation and Plaque Progression: Plaque-Free vs Plaque-Adjacent Segments. JACC Cardiovasc Imaging. 2026 Oct 16:S1936-878X(26)00500-0. doi: 10.1016/j.jcmg.2026.08.018. Online ahead of print.
PubMed 42900033Won KB, Lee BK, Hadamitzky M, Kim YJ, Sung JM, Conte E, Pontone G, Andreini D, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Leipsic JA, Lee SE, Shin S, Choi JH, Samady H, Chinnaiyan K, Narula J, Shaw LJ, Bax JJ, Min JK, Chang HJ. Rapid progression of coronary atherosclerosis across glycemic status: a serial coronary computed tomography angiography study from the PARADIGM registry. Cardiovasc Diabetol. 2026 Sep 5;25(1):301. doi: 10.1186/s12933-026-03355-1.
PubMed 42850638Won KB, Lee BK, Hadamitzky M, Kim YJ, Sung JM, Conte E, Pontone G, Andreini D, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Leipsic JA, Lee SE, Shin S, Choi JH, Samady H, Chinnaiyan K, Narula J, Shaw LJ, Bax JJ, Min JK, Chang HJ. Association between atherogenic index of plasma and rapid progression of coronary atherosclerosis in non-diabetic and diabetic adults: Insight from the PARADIGM study. J Cardiovasc Comput Tomogr. 2026 May-Jun;20(3):272-278. doi: 10.1016/j.jcct.2026.03.011. Epub 2026 Apr 10.
PubMed 41963235Neglia D, Caselli C, Maffei E, Cademartiri F, Meloni A, Bossone E, Saba L, Lee SE, Sung JM, Andreini D, Al-Mallah MH, Budoff MJ, Chinnaiyan K, Choi JH, Chun EJ, Conte E, Gottlieb I, Hadamitzky M, Kim YJ, Lee BK, Leipsic JA, Marques H, de Araujo Goncalves P, Pontone G, Shin S, Stone PH, Samady H, Virmani R, Narula J, Shaw LJ, Bax JJ, Lin FY, Min JK, Chang HJ. Rapid Plaque Progression Is Independently Associated With Hyperglycemia and Low HDL Cholesterol in Patients With Stable Coronary Artery Disease: A PARADIGM Study. Circ Cardiovasc Imaging. 2024 Jul;17(7):e016481. doi: 10.1161/CIRCIMAGING.123.016481. Epub 2024 Jul 16.
PubMed 39012946Park HB, Arsanjani R, Sung JM, Heo R, Lee BK, Lin FY, Hadamitzky M, Kim YJ, Conte E, Andreini D, Pontone G, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, Goncalves PA, Leipsic JA, Lee SE, Shin S, Choi JH, Virmani R, Samady H, Chinnaiyan K, Stone PH, Berman DS, Narula J, Shaw LJ, Bax JJ, Min JK, Chang HJ. Impact of statins based on high-risk plaque features on coronary plaque progression in mild stenosis lesions: results from the PARADIGM study. Eur Heart J Cardiovasc Imaging. 2023 Oct 27;24(11):1536-1543. doi: 10.1093/ehjci/jead110.
PubMed 37232393Won KB, Lee BK, Lin FY, Hadamitzky M, Kim YJ, Sung JM, Conte E, Andreini D, Pontone G, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Leipsic JA, Lee SE, Shin S, Choi JH, Virmani R, Samady H, Chinnaiyan K, Berman DS, Narula J, Shaw LJ, Bax JJ, Min JK, Chang HJ. Glycemic control is independently associated with rapid progression of coronary atherosclerosis in the absence of a baseline coronary plaque burden: a retrospective case-control study from the PARADIGM registry. Cardiovasc Diabetol. 2022 Nov 12;21(1):239. doi: 10.1186/s12933-022-01656-9.
PubMed 36371222Won KB, Lee BK, Heo R, Park HB, Lin FY, Hadamitzky M, Kim YJ, Sung JM, Conte E, Andreini D, Pontone G, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Leipsic JA, Lee SE, Shin S, Choi JH, Virmani R, Samady H, Chinnaiyan K, Berman DS, Narula J, Bax JJ, Min JK, Chang HJ. Longitudinal Quantitative Assessment of Coronary Atherosclerotic Plaque Burden Related to Serum Hemoglobin Levels. JACC Asia. 2022 Apr 12;2(3):311-319. doi: 10.1016/j.jacasi.2021.10.010. eCollection 2022 Jun.
PubMed 36338409Lee SE, Sung JM, Andreini D, Al-Mallah MH, Budoff MJ, Cademartiri F, Chinnaiyan K, Choi JH, Chun EJ, Conte E, Gottlieb I, Hadamitzky M, Kim YJ, Lee BK, Leipsic JA, Maffei E, Marques H, de Araujo Goncalves P, Pontone G, Shin S, Kitslaar PH, Reiber JHC, Stone PH, Samady H, Virmani R, Narula J, Berman DS, Shaw LJ, Bax JJ, Lin FY, Min JK, Chang HJ. Association Between Changes in Perivascular Adipose Tissue Density and Plaque Progression. JACC Cardiovasc Imaging. 2022 Oct;15(10):1760-1767. doi: 10.1016/j.jcmg.2022.04.016. Epub 2022 Jun 15.
PubMed 36202455Takagi H, Leipsic JA, Indraratna P, Gulsin G, Khasanova E, Tzimas G, Lin FY, Shaw LJ, Lee SE, 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, Maffei E, Pontone G, Shin S, Kim YJ, Lee BK, Chun EJ, Sung JM, Virmani R, Samady H, Stone PH, Berman DS, Narula J, Bax JJ, Chang HJ. Association of Tube Voltage With Plaque Composition on Coronary CT Angiography: Results From PARADIGM Registry. JACC Cardiovasc Imaging. 2021 Dec;14(12):2429-2440. doi: 10.1016/j.jcmg.2021.07.011. Epub 2021 Aug 18.
PubMed 34419398Hwang D, Kim HJ, Lee SP, Lim S, Koo BK, Kim YJ, Kook W, 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, Raff GL, Shin S, Lee BK, Chun EJ, Sung JM, Lee SE, Berman DS, Lin FY, Virmani R, Samady H, Stone PH, Narula J, Bax JJ, Shaw LJ, Min JK, Chang HJ. Topological Data Analysis of Coronary Plaques Demonstrates the Natural History of Coronary Atherosclerosis. JACC Cardiovasc Imaging. 2021 Jul;14(7):1410-1421. doi: 10.1016/j.jcmg.2020.11.009. Epub 2021 Jan 13.
PubMed 33454260Jin HY, Weir-McCall JR, Leipsic JA, Son JW, Sellers SL, Shao M, Blanke P, Ahmadi A, Hadamitzky M, Kim YJ, Conte E, Andreini D, Pontone G, Budoff MJ, Gottlieb I, Lee BK, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Shin S, Choi JH, Virmani R, Samady H, Stone PH, Berman DS, Narula J, Shaw LJ, Bax JJ, Chinnaiyan K, Raff G, Al-Mallah MH, Lin FY, Min JK, Sung JM, Lee SE, Chang HJ. The Relationship Between Coronary Calcification and the Natural History of Coronary Artery Disease. JACC Cardiovasc Imaging. 2021 Jan;14(1):233-242. doi: 10.1016/j.jcmg.2020.08.036. Epub 2020 Nov 18.
PubMed 33221216Kim M, Lee SP, Kwak S, Yang S, Kim YJ, 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, Raff GL, Shin S, Lee BK, Chun EJ, Sung JM, Lee SE, Berman DS, Lin FY, Virmani R, Samady H, Stone PH, Narula J, Bax JJ, Shaw LJ, Min JK, Chang HJ. Impact of age on coronary artery plaque progression and clinical outcome: A PARADIGM substudy. J Cardiovasc Comput Tomogr. 2021 May-Jun;15(3):232-239. doi: 10.1016/j.jcct.2020.09.009. Epub 2020 Oct 1.
PubMed 33032975Lee SE, Sung JM, Andreini D, Al-Mallah MH, Budoff MJ, Cademartiri F, Chinnaiyan K, Choi JH, Chun EJ, Conte E, Gottlieb I, Hadamitzky M, Kim YJ, Lee BK, Leipsic JA, Maffei E, Marques H, de Araujo Goncalves P, Pontone G, Shin S, Stone PH, Samady H, Virmani R, Narula J, Berman DS, Shaw LJ, Bax JJ, Lin FY, Min JK, Chang HJ. Sex Differences in Compositional Plaque Volume Progression in Patients With Coronary Artery Disease. JACC Cardiovasc Imaging. 2020 Nov;13(11):2386-2396. doi: 10.1016/j.jcmg.2020.06.034. Epub 2020 Aug 19.
PubMed 32828763Lee SE, Sung JM, Andreini D, Al-Mallah MH, Budoff MJ, Cademartiri F, Chinnaiyan K, Choi JH, Chun EJ, Conte E, Gottlieb I, Hadamitzky M, Kim YJ, Lee BK, Leipsic JA, Maffei E, Marques H, de Araujo Goncalves P, Pontone G, Shin S, Stone PH, Samady H, Virmani R, Narula J, Berman DS, Shaw LJ, Bax JJ, Lin FY, Min JK, Chang HJ. Per-lesion versus per-patient analysis of coronary artery disease in predicting the development of obstructive lesions: the Progression of AtheRosclerotic PlAque DetermIned by Computed TmoGraphic Angiography Imaging (PARADIGM) study. Int J Cardiovasc Imaging. 2020 Dec;36(12):2357-2364. doi: 10.1007/s10554-020-01960-z. Epub 2020 Aug 10.
PubMed 32779077
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)
- ClinicalTrials.gov ID
- NCT02803411
- Acronym / sponsor ID
- PARADIGM / 4-2016-0263
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Heart Disease, Coronary Computed Tomography Angiography (CCTA), Coronary Atherosclerotic Plaque, coronary atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Montreal Heart Institute, Hospital da Luz, Portugal, University of California, Los Angeles, Centro Cardiologico Monzino, University of British Columbia, German Heart Institute, National Institute of Cardiology, Laranjeiras, Brazil, Weill Medical College of Cornell University, Cedars-Sinai Medical Center
- Study start
- Mar 2003
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the natural history of the coronary atherosclerotic plaque development and progression over time by CCTA with demographic and laboratory data for refinement of risk stratification of patients referred for CCTA.
Detailed description
All PARADIGM study patients underwent initial and follow-up CCTA based on order from their primary physician. Demographic data, targeted medical history, cardiovascular risk factors, and laboratory data was prospectively collected in electronic case report forms (eCRFs) at the time of the initial CCTA and at the time of follow-up CCTA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is patients with suspected or known CAD who had undergone serial CCTA by physician referral. Sites that had collected cohorts of CCTA patients with symptoms, risk factors, CCTA image data, and outcomes were invited to contribute data for a merged database. This sample includes patients with suspected or known CAD, and asymptomatic subjects undergoing CCTA for risk stratification to evaluate the significance of changes in CCTA findings in different clinical contexts.
Key inclusion criteria (2 listed)
- patients underwent two or more clinically indicated CCTA with 64-detector rows or greater for CAD evaluation
- patients underwent at least 2 year interval between the baseline and follow-up CCTA
Key exclusion criteria (1 listed)
- poor image quality of CCTA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in plaque volume and composition detected by follow up CCTA
Time frame: 2 years
4 secondary outcomes
Cardiac mortality (yes or no)
Time frame: 2 years
Myocardial infarction (yes or no)
Time frame: 2 years
Unstable angina requiring hospitalization (yes or no)
Time frame: 2 years
Revascularization (yes or no)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Background: PubMed 27914502Lee SE, Chang HJ, Rizvi A, Hadamitzky M, Kim YJ, Conte E, Andreini D, Pontone G, Volpato V, Budoff MJ, Gottlieb I, Lee BK, Chun EJ, Cademartiri F, Maffei E, Marques H, Leipsic JA, Shin S, Choi JH, Chung N, Min JK. Rationale and design of the Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography IMaging (PARADIGM) registry: A comprehensive exploration of plaque progression and its impact on clinical outcomes from a multicenter serial coronary computed tomographic angiography study. Am Heart J. 2016 Dec;182:72-79. doi: 10.1016/j.ahj.2016.09.003. Epub 2016 Sep 22.
- Derived from this study: PubMed 42900033Lee SE, Sung JM, Andreini D, Al-Mallah MH, Budoff MJ, Cademartiri F, Chinnaiyan K, Choi JH, Chun EJ, Conte E, Gottlieb I, Hadamitzky M, Kim YJ, Lee BK, Leipsic JA, Maffei E, Marques H, de Araujo Goncalves P, Pontone G, Stone PH, Virmani R, Narula J, Shaw LJ, Bax JJ, Lin FY, Min JK, Chang HJ. Patient-Level Perivascular Adipose Tissue Density Aggregation and Plaque Progression: Plaque-Free vs Plaque-Adjacent Segments. JACC Cardiovasc Imaging. 2026 Oct 16:S1936-878X(26)00500-0. doi: 10.1016/j.jcmg.2026.08.018. Online ahead of print.
- Derived from this study: PubMed 42850638Won KB, Lee BK, Hadamitzky M, Kim YJ, Sung JM, Conte E, Pontone G, Andreini D, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Leipsic JA, Lee SE, Shin S, Choi JH, Samady H, Chinnaiyan K, Narula J, Shaw LJ, Bax JJ, Min JK, Chang HJ. Rapid progression of coronary atherosclerosis across glycemic status: a serial coronary computed tomography angiography study from the PARADIGM registry. Cardiovasc Diabetol. 2026 Sep 5;25(1):301. doi: 10.1186/s12933-026-03355-1.
- Derived from this study: PubMed 41963235Won KB, Lee BK, Hadamitzky M, Kim YJ, Sung JM, Conte E, Pontone G, Andreini D, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Leipsic JA, Lee SE, Shin S, Choi JH, Samady H, Chinnaiyan K, Narula J, Shaw LJ, Bax JJ, Min JK, Chang HJ. Association between atherogenic index of plasma and rapid progression of coronary atherosclerosis in non-diabetic and diabetic adults: Insight from the PARADIGM study. J Cardiovasc Comput Tomogr. 2026 May-Jun;20(3):272-278. doi: 10.1016/j.jcct.2026.03.011. Epub 2026 Apr 10.
- Derived from this study: PubMed 39012946Neglia D, Caselli C, Maffei E, Cademartiri F, Meloni A, Bossone E, Saba L, Lee SE, Sung JM, Andreini D, Al-Mallah MH, Budoff MJ, Chinnaiyan K, Choi JH, Chun EJ, Conte E, Gottlieb I, Hadamitzky M, Kim YJ, Lee BK, Leipsic JA, Marques H, de Araujo Goncalves P, Pontone G, Shin S, Stone PH, Samady H, Virmani R, Narula J, Shaw LJ, Bax JJ, Lin FY, Min JK, Chang HJ. Rapid Plaque Progression Is Independently Associated With Hyperglycemia and Low HDL Cholesterol in Patients With Stable Coronary Artery Disease: A PARADIGM Study. Circ Cardiovasc Imaging. 2024 Jul;17(7):e016481. doi: 10.1161/CIRCIMAGING.123.016481. Epub 2024 Jul 16.
- Derived from this study: PubMed 37232393Park HB, Arsanjani R, Sung JM, Heo R, Lee BK, Lin FY, Hadamitzky M, Kim YJ, Conte E, Andreini D, Pontone G, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, Goncalves PA, Leipsic JA, Lee SE, Shin S, Choi JH, Virmani R, Samady H, Chinnaiyan K, Stone PH, Berman DS, Narula J, Shaw LJ, Bax JJ, Min JK, Chang HJ. Impact of statins based on high-risk plaque features on coronary plaque progression in mild stenosis lesions: results from the PARADIGM study. Eur Heart J Cardiovasc Imaging. 2023 Oct 27;24(11):1536-1543. doi: 10.1093/ehjci/jead110.
- Derived from this study: PubMed 36371222Won KB, Lee BK, Lin FY, Hadamitzky M, Kim YJ, Sung JM, Conte E, Andreini D, Pontone G, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Leipsic JA, Lee SE, Shin S, Choi JH, Virmani R, Samady H, Chinnaiyan K, Berman DS, Narula J, Shaw LJ, Bax JJ, Min JK, Chang HJ. Glycemic control is independently associated with rapid progression of coronary atherosclerosis in the absence of a baseline coronary plaque burden: a retrospective case-control study from the PARADIGM registry. Cardiovasc Diabetol. 2022 Nov 12;21(1):239. doi: 10.1186/s12933-022-01656-9.
- Derived from this study: PubMed 36338409Won KB, Lee BK, Heo R, Park HB, Lin FY, Hadamitzky M, Kim YJ, Sung JM, Conte E, Andreini D, Pontone G, Budoff MJ, Gottlieb I, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Leipsic JA, Lee SE, Shin S, Choi JH, Virmani R, Samady H, Chinnaiyan K, Berman DS, Narula J, Bax JJ, Min JK, Chang HJ. Longitudinal Quantitative Assessment of Coronary Atherosclerotic Plaque Burden Related to Serum Hemoglobin Levels. JACC Asia. 2022 Apr 12;2(3):311-319. doi: 10.1016/j.jacasi.2021.10.010. eCollection 2022 Jun.
- Derived from this study: PubMed 36202455Lee SE, Sung JM, Andreini D, Al-Mallah MH, Budoff MJ, Cademartiri F, Chinnaiyan K, Choi JH, Chun EJ, Conte E, Gottlieb I, Hadamitzky M, Kim YJ, Lee BK, Leipsic JA, Maffei E, Marques H, de Araujo Goncalves P, Pontone G, Shin S, Kitslaar PH, Reiber JHC, Stone PH, Samady H, Virmani R, Narula J, Berman DS, Shaw LJ, Bax JJ, Lin FY, Min JK, Chang HJ. Association Between Changes in Perivascular Adipose Tissue Density and Plaque Progression. JACC Cardiovasc Imaging. 2022 Oct;15(10):1760-1767. doi: 10.1016/j.jcmg.2022.04.016. Epub 2022 Jun 15.
- Derived from this study: PubMed 34419398Takagi H, Leipsic JA, Indraratna P, Gulsin G, Khasanova E, Tzimas G, Lin FY, Shaw LJ, Lee SE, 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, Maffei E, Pontone G, Shin S, Kim YJ, Lee BK, Chun EJ, Sung JM, Virmani R, Samady H, Stone PH, Berman DS, Narula J, Bax JJ, Chang HJ. Association of Tube Voltage With Plaque Composition on Coronary CT Angiography: Results From PARADIGM Registry. JACC Cardiovasc Imaging. 2021 Dec;14(12):2429-2440. doi: 10.1016/j.jcmg.2021.07.011. Epub 2021 Aug 18.
- Derived from this study: PubMed 33454260Hwang D, Kim HJ, Lee SP, Lim S, Koo BK, Kim YJ, Kook W, 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, Raff GL, Shin S, Lee BK, Chun EJ, Sung JM, Lee SE, Berman DS, Lin FY, Virmani R, Samady H, Stone PH, Narula J, Bax JJ, Shaw LJ, Min JK, Chang HJ. Topological Data Analysis of Coronary Plaques Demonstrates the Natural History of Coronary Atherosclerosis. JACC Cardiovasc Imaging. 2021 Jul;14(7):1410-1421. doi: 10.1016/j.jcmg.2020.11.009. Epub 2021 Jan 13.
- Derived from this study: PubMed 33221216Jin HY, Weir-McCall JR, Leipsic JA, Son JW, Sellers SL, Shao M, Blanke P, Ahmadi A, Hadamitzky M, Kim YJ, Conte E, Andreini D, Pontone G, Budoff MJ, Gottlieb I, Lee BK, Chun EJ, Cademartiri F, Maffei E, Marques H, de Araujo Goncalves P, Shin S, Choi JH, Virmani R, Samady H, Stone PH, Berman DS, Narula J, Shaw LJ, Bax JJ, Chinnaiyan K, Raff G, Al-Mallah MH, Lin FY, Min JK, Sung JM, Lee SE, Chang HJ. The Relationship Between Coronary Calcification and the Natural History of Coronary Artery Disease. JACC Cardiovasc Imaging. 2021 Jan;14(1):233-242. doi: 10.1016/j.jcmg.2020.08.036. Epub 2020 Nov 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyuk-Jae Chang, MD, PhD principal investigator
Yonsei Univerity
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plaque volume and composition detected by follow up CCTA (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803411, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.