AzTrials
AzTrials

Ischemic Heart DiseaseNCT03795714

Association Between IVUS and OCT Parameters and Invasive Physiologic Indices

An observational study of Ischemic Heart Disease, run by Seoul National University Hospital at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

1. to evaluate diagnostic accuracy and performance of IVUS and OCT-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices. 2. Read more about this study

Who is it for?
Any age
Conditions the study is for
Ischemic Heart Disease
What is being tested?
IVUS or OCT and Invasive physiologic indices
How many people
166 participants
Where
2 sitesSouth Korea
Study dates
17 Nov 2017to 31 Mar 2019
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment and invasive physiologic assessment.

Who may be able to join

  • Patients who suspected ischemic heart disease, and underwent invasive physiologic assessment and intravascular ultrasound

Who cannot join

  • Cardiogenic shock
  • Graft vessel
  • In-stent restenosis

Trial locations and contacts

2 sites in 1 country.

Joo Myung Lee, MD, MPH, PhD contact

82-10-8884-8439

drone80@hanmail.net

Ki Hong Choi, MD contact

82-10-8875-1648

cardiokh@gmail.com

South Korea2 sites, 2 recruiting

  • Samsung Medical Center

    Seoul, 06351

    Joo Myung Lee, MD, MPH, PhD, drone80@hanmail.net

    Ki Hong Choi, MD, cardiokh@gmail.com

    Recruiting

  • Seoul national university hospital

    Seoul, 110-744

    Bon-kown Koo, MD/PhD, 82-2-2072-2062, bkkoo@snu.ac.kr

    Bon-kwon Koo, MD/PhD

    Recruiting

Other trials in South Korea

About this study

Official title: Intravascular Ultrasound and Optical Coherence Tomography-Defined Optimal Criteria and Plaque Characteristics for Defining the Functional Significance of Coronary Stenoses Using Resting and Hyperemic Physiologic Indices

  1. to evaluate diagnostic accuracy and performance of IVUS and OCT-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices.
  2. to explores the association between intravascular imaging-derived plaque characteristics and invasive physiologic indices.
Read the detailed description

Given the inherent limitations of coronary angiography to depict the presence of functionally significant epicardial coronary stenosis and discrepancy between angiographic stenosis severity and the presence of myocardial ischemia, invasive physiologic indices such as fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) has been a standard method to guide decision of revascularization.

Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are an intracoronary imaging method able to provide information about lumen area, vessel area, plaque burden, and plaque characteristics that can be used for the guidance of revascularization procedure. Several previous studies explored the diagnostic performance of intravascular imaging-defined quantitative parameters to predict functional significance defined by FFR, however, quantitative parameter derived from intravascular imaging showed only moderate diagnostic accuracy and the optimal cut-off value of intravascular imaging-derived minimal lumen area (MLA) or minimal lumen diameter (MLD) were varied according to the patient population, interrogated vessels, and the location of target lesions, suggesting limited clinical relevance of judging functional significance of target stenosis using intravascular imaging alone. Nevertheless, the adoption rate of FFR-guided decision has been limited due to various reasons and intravascular image-guided decision has been still used in substantial proportion of the patients.

Recently, new resting pressure-derived indices including resting full-cycle ratio (RFR) or diastolic pressure ratio (dPR) have been introduced as other substitutes for iFR, which does not require administration of hyperemic agents, therefore, possess more convenient in daily practice. Recent study with the largest sample size demonstrated identical diagnostic property and prognostic implication among iFR, RFR, and dPR. As those resting pressure-derived indices might have more generalizability for daily practice, it is expected to raise the adoption rate of physiologic interrogation. Therefore, understanding the association between all the available physiologic indices and intravascular imaging-derived quantitative and qualitative parameters might be important in clinical decision for patient who underwent invasive coronary angiography.

In this regard, the investigators sought to evaluate diagnostic accuracy and performance of intravascular imaging-derived quantitative parameters to predict functional significance of stenosis defined using all the available physiologic indices and further explores the association between IVUS and OCT-derived plaque characteristics and invasive physiologic indices.

Being tested
IVUS or OCT and Invasive physiologic indices
Keywords
Intravascular Ultrasound, Optical Coherence Tomography, Fractional Flow Reserve, Diastolic Pressure Ratio, Resting Full-Cycle Ratio, Ischemic Heart Disease, Instantaneous Wave-free Ratio
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVUS or OCT and Invasive physiologic indicesDiagnostic test

    IVUS or OCT measurement in order to evaluate the lesion morphology and stent optimization, and invasive physiologic measurement in order to functional significance of epicardial stenosis

Study groups in NCT03795714
Study groupRoleWhat they receive
Intravascular Imaging and Physiologic Assessment330 patients with suspected ischemic heart disease and who underwent IVUS or OCT assessment and invasive physiologic assessment.
Receives: Diagnostic Test: IVUS or OCT and Invasive physiologic indices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by fractional flow reserve (FFR)

    Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  2. Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by instantaneous wave-free ratio (iFR)

    Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  3. Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by diastolic pressure ratio (dPR)

    Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  4. Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by resting full-cycle ratio (RFR)

    Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  5. Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR

    Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  6. Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR

    Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  7. Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR

    Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  8. Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR

    Diagnostic accuracy of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  9. Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR

    Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  10. Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR

    Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  11. Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR

    Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  12. Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR

    Diagnostic accuracy of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  13. Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR

    Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  14. Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by iFR

    Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  15. Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance assessed by dPR

    Diagnostic accuracy of plaque burden assessed by IVUS to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  16. Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR

    Diagnostic accuracy of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

Secondary outcomes (64)

  1. Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR

    Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  2. Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR

    Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  3. Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR

    Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  4. Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR

    Sensitivity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  5. Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR

    Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  6. Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR

    Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  7. Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR

    Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  8. Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR

    Sensitivity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  9. Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR

    Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  10. Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR

    Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  11. Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR

    Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  12. Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR

    Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  13. Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR

    Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  14. Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR

    Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  15. Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR

    Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  16. Sensitivity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR

    Sensitivity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  17. Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by FFR

    Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  18. Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by iFR

    Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  19. Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by dPR

    Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  20. Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by RFR

    Specificity of percent diameter stenosis assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  21. Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by FFR

    Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  22. Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by iFR

    Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  23. Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by dPR

    Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  24. Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance assessed by RFR

    Specificity of minimal lumen diameter assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  25. Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by FFR

    Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  26. Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by iFR

    Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  27. Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by dPR

    Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  28. Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance assessed by RFR

    Specificity of minimal lumen area assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  29. Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by FFR

    Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by FFR ≤0.80

    Measured: During Cardiac Cath

  30. Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by iFR

    Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by iFR ≤0.89

    Measured: During Cardiac Cath

  31. Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by dPR

    Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by dPR ≤0.89

    Measured: During Cardiac Cath

  32. Specificity of plaque burden assessed by intravascular imaging to predict functional significance assessed by RFR

    Specificity of plaque burden assessed by intravascular imaging to predict functional significance defined by RFR ≤0.89

    Measured: During Cardiac Cath

  33. Linear correlation between percent diameter stenosis and FFR

    Linear regression analysis between percent diameter stenosis and FFR

    Measured: During Cardiac Cath

  34. Linear correlation between percent diameter stenosis and iFR

    Linear regression analysis between percent diameter stenosis and iFR

    Measured: During Cardiac Cath

  35. Linear correlation between percent diameter stenosis and dPR

    Linear regression analysis between percent diameter stenosis and dPR

    Measured: During Cardiac Cath

  36. Linear correlation between percent diameter stenosis and RFR

    Linear regression analysis between percent diameter stenosis and RFR

    Measured: During Cardiac Cath

  37. Linear correlation between minimal lumen diameter and FFR

    Linear regression analysis between minimal lumen diameter and FFR

    Measured: During Cardiac Cath

  38. Linear correlation between minimal lumen diameter and iFR

    Linear regression analysis between minimal lumen diameter and iFR

    Measured: During Cardiac Cath

  39. Linear correlation between minimal lumen diameter and dPR

    Linear regression analysis between minimal lumen diameter and dPR

    Measured: During Cardiac Cath

  40. Linear correlation between minimal lumen diameter and RFR

    Linear regression analysis between minimal lumen diameter and RFR

    Measured: During Cardiac Cath

  41. Linear correlation between minimal lumen area and FFR

    Linear regression analysis between minimal lumen area and FFR

    Measured: During Cardiac Cath

  42. Linear correlation between minimal lumen area and iFR

    Linear regression analysis between minimal lumen area and iFR

    Measured: During Cardiac Cath

  43. Linear correlation between minimal lumen area and dPR

    Linear regression analysis between minimal lumen area and dPR

    Measured: During Cardiac Cath

  44. Linear correlation between minimal lumen area and RFR

    Linear regression analysis between minimal lumen area and RFR

    Measured: During Cardiac Cath

  45. Linear correlation between plaque burden and FFR

    Linear regression analysis between plaque burden and FFR

    Measured: During Cardiac Cath

  46. Linear correlation between plaque burden and iFR

    Linear regression analysis between plaque burden and iFR

    Measured: During Cardiac Cath

  47. Linear correlation between plaque burden and dPR

    Linear regression analysis between plaque burden and dPR

    Measured: During Cardiac Cath

  48. Linear correlation between plaque burden and RFR

    Linear regression analysis between plaque burden and RFR

    Measured: During Cardiac Cath

  49. Discriminatory function of percent diameter stenosis to predict functional significance assessed by FFR

    Discriminatory function of percent diameter stenosis to predict functional significance defined by FFR≤0.80

    Measured: During Cardiac Cath

  50. Discriminatory function of percent diameter stenosis to predict functional significance assessed by iFR

    Discriminatory function of percent diameter stenosis to predict functional significance defined by iFR≤0.89

    Measured: During Cardiac Cath

  51. Discriminatory function of percent diameter stenosis to predict functional significance assessed by dPR

    Discriminatory function of percent diameter stenosis to predict functional significance defined by dPR≤0.89

    Measured: During Cardiac Cath

  52. Discriminatory function of percent diameter stenosis to predict functional significance assessed by RFR

    Discriminatory function of percent diameter stenosis to predict functional significance defined by RFR≤0.89

    Measured: During Cardiac Cath

  53. Discriminatory function of minimal lumen diameter to predict functional significance assessed by FFR

    Discriminatory function of minimal lumen diameter to predict functional significance defined by FFR≤0.80

    Measured: During Cardiac Cath

  54. Discriminatory function of minimal lumen diameter to predict functional significance assessed by iFR

    Discriminatory function of minimal lumen diameter to predict functional significance defined by iFR≤0.89

    Measured: During Cardiac Cath

  55. Discriminatory function of minimal lumen diameter to predict functional significance assessed by dPR

    Discriminatory function of minimal lumen diameter to predict functional significance defined by dPR≤0.89

    Measured: During Cardiac Cath

  56. Discriminatory function of minimal lumen diameter to predict functional significance assessed by RFR

    Discriminatory function of minimal lumen diameter to predict functional significance defined by RFR≤0.89

    Measured: During Cardiac Cath

  57. Discriminatory function of minimal lumen area to predict functional significance assessed by FFR

    Discriminatory function of minimal lumen area to predict functional significance defined by FFR≤0.80

    Measured: During Cardiac Cath

  58. Discriminatory function of minimal lumen area to predict functional significance assessed by iFR

    Discriminatory function of minimal lumen area to predict functional significance defined by iFR≤0.89

    Measured: During Cardiac Cath

  59. Discriminatory function of minimal lumen area to predict functional significance assessed by dPR

    Discriminatory function of minimal lumen area to predict functional significance defined by dPR≤0.89

    Measured: During Cardiac Cath

  60. Discriminatory function of minimal lumen area to predict functional significance assessed by RFR

    Discriminatory function of minimal lumen area to predict functional significance defined by RFR≤0.89

    Measured: During Cardiac Cath

  61. Discriminatory function of plaque burden to predict functional significance assessed by FFR

    Discriminatory function of plaque burden to predict functional significance defined by FFR≤0.80

    Measured: During Cardiac Cath

  62. Discriminatory function of plaque burden to predict functional significance assessed by iFR

    Discriminatory function of plaque burden to predict functional significance defined by iFR≤0.89

    Measured: During Cardiac Cath

  63. Discriminatory function of plaque burden to predict functional significance assessed by dPR

    Discriminatory function of plaque burden to predict functional significance defined by dPR≤0.89

    Measured: During Cardiac Cath

  64. Discriminatory function of plaque burden to predict functional significance assessed by RFR

    Discriminatory function of plaque burden to predict functional significance defined by RFR≤0.89

    Measured: During Cardiac Cath

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2019
  2. Study start17 Nov 2017
  3. Primary completion31 Jan 2019 (estimated)
  4. Study completion31 Mar 2019 (estimated)

Resources

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
Case only
Time perspective
Retrospective
Enrolment
166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03795714
Sponsor's protocol ID
IVUS2017-11-056-001
Status last verified
Jan 2019
First submitted
28 Dec 2018
Last updated
22 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lee JM, Choi KH, Koo BK, Zhang J, Han JK, Yang HM, Park KW, Song YB, Hahn JY, Choi SH, Gwon HC, Kim HS. Intravascular ultrasound or optical coherence tomography-defined anatomic severity and hemodynamic severity assessed by coronary physiologic indices. Rev Esp Cardiol (Engl Ed). 2020 Oct;73(10):812-821. doi: 10.1016/j.rec.2019.11.001. Epub 2019 Dec 4. English, Spanish.

    PubMed 31812517

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Heart Disease, run by Seoul National University Hospital at 2 sites in South Korea.

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 1 inclusion and 3 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 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Joo Myung Lee, MD, MPH, PhD (82-10-8884-8439, drone80@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy of percent diameter stenosis assessed by intravascular imaging to predict functional significance assessed by fractional flow reserve (FFR) (time frame: During Cardiac Cath). The study lists 16 primary outcomes in all. 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 NCT03795714, which also lists 1 linked publication.

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 22 Jan 2019; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in