Ultra-high-resolution CT vs. Conventional Angiography for Detecting Coronary Heart Disease

NCT04272060 | Completed Results DMC FDA Device

• 1 other identifier: IRB00209321
• Study Type: interventional
• Target: 175
• Locations: 3 countries
• Sites: 3

Brief Summary

Cardiac catheterization with invasive coronary angiography is the gold standard for determining the presence or absence of significant coronary heart disease (CHD). However, cardiac catheterization is costly and, as an invasive procedure, it is associated with some risk of adverse events, rarely even stroke, myocardial infarction, or death. Recent advances in multi-detector computed tomography angiography (CTA) have allowed rapid, noninvasive coronary artery imaging in patients with suspected CHD. CTA generally yields high accuracy for identifying patients with CHD when compared to cardiac catheterization. However, diagnostic accuracy is reduced in the setting of severe coronary artery calcification and coronary stents due to its inferior spatial resolution compared to cardiac catheterization. Because high-risk patients often have severe coronary calcification or stents, the application of CTA has been particularly limited in this important patient group. Recently, an ultrahigh-resolution CT scanner was released which has shown promise to overcome the limitation of conventional CTA in the setting of severe coronary artery calcification or stents. This ultrahigh-resolution "precision" CT scanner (UHR-CT) contains detector rows with half the width than currently available systems (0.25 mm vs. 0.5 mm) resulting in approximately twice the spatial resolution. The purpose of this investigation is to test the hypothesis that high-resolution CTA is not inferior to the current standard of cardiac catheterization for identifying significant CHD in patients with high-risk characteristics, including severe coronary artery calcification and coronary stents. The investigators propose to enroll 50 patients over 24-30 months in this investigation as part of a multicenter study. Patients referred for cardiac catheterization with known CHD and suspected obstructive coronary artery stenosis will be included. All patients will undergo both cardiac catheterization and UHR-CT for determining significant CHD as defined by coronary functional assessment. The primary end point will be the diagnostic accuracy by area-under-curve (AUC) method for identifying patients with hemodynamically significant CHD.

Conditions

Coronary Artery Disease

Keywords

coronary heart disease; coronary angiography; CT angiography; cardiac catheterization

Outcome Measures

Primary Outcomes (1)

• Percentage of Correctly Classified Coronary Artery Disease Patients (True Positives and True Negatives)

  The primary outcome was the patient-level diagnostic accuracy of ultra-high-resolution computed tomography (UHR-CT) compared with invasive coronary angiography (ICA) for identifying hemodynamically significant coronary artery disease (CAD), using quantitative flow ratio (QFR ≤0.80) as the reference standard. For each patient, the highest-grade stenosis across all coronary vessels determined by UHR-CT and ICA was used to classify the test result. Diagnostic accuracy was defined as the percentage of correctly classified patients (true positives and true negatives) relative to QFR.

  Up to 90 days

Secondary Outcomes (3)

• Sensitivity, Specificity, and Accuracy of UHR-CT and ICA

  Up to 90 days

• Percentage Agreement Between UHR-CT and ICA

  Up to 90 days

• Accurately Detected Functionally Significant Stenosis

  Up to 90 days

Other Outcomes (1)

• Diagnostic Accuracy Across Prespecified Subgroups

  Up to 90 days

Study Arms (2)

CT Angiography

EXPERIMENTAL

Research CT angiography.

Diagnostic Test: CT angiography

Conventional Angiography

ACTIVE COMPARATOR

Standard medical care which includes cardiac catheterization and invasive coronary angiography.

Diagnostic Test: Invasive coronary angiography

Interventions

CT angiography DIAGNOSTIC_TEST

Diagnostic CT angiography

CT Angiography

Invasive coronary angiography DIAGNOSTIC_TEST

Diagnostic invasive coronary angiography

Conventional Angiography

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 45-85 years with history of CHD will be asked to participate. History of CHD is defined as prior documentation of a coronary artery stenosis of 50% or greater by coronary angiography or by prior documentation of coronary artery revascularization by percutaneous coronary intervention (PCI). Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA.
• Suspected obstructive coronary artery stenosis based on clinical history and/or noninvasive testing, prompting a clinical referral for invasive coronary angiography; and/or planned PCI within the next 60 days.
• Ability to understand and willingness to sign the Informed Consent Form.

You may not qualify if:

• Known allergy to iodinated contrast media
• History of multiple myeloma or previous organ transplantation
• Elevated serum creatinine (\> 1.5mg/dl) or calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula
• Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third-degree heart block)
• Evidence of severe symptomatic heart failure (NYHA Class III or IV);
• Known or suspected moderate or severe aortic stenosis
• Previous coronary artery bypass or other cardiac surgery
• Patients without a history of CHD who had no or only mild coronary calcification on chest CT imaging within the past 5 years or had most recent coronary calcium scan with a score \<400
• Suspected acute coronary syndrome
• Presence of any other history or condition that the investigator feels would be problematic

Sponsors & Collaborators

• Johns Hopkins University: lead
• Canon Medical Systems, USA: collaborator

Study Sites (3)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Hospital Israelita Albert Einstein

São Paulo, Brazil

Location

Iwate Medical University

Morioka, Japan

Location

Related Publications (7)

• Raff GL, Gallagher MJ, O'Neill WW, Goldstein JA. Diagnostic accuracy of noninvasive coronary angiography using 64-slice spiral computed tomography. J Am Coll Cardiol. 2005 Aug 2;46(3):552-7. doi: 10.1016/j.jacc.2005.05.056.

  PMID: 16053973 RESULT

• Arbab-Zadeh A, Miller JM, Rochitte CE, Dewey M, 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 accuracy of computed tomography coronary angiography according to pre-test probability of coronary artery disease and severity of coronary arterial calcification. The CORE-64 (Coronary Artery Evaluation Using 64-Row Multidetector Computed Tomography Angiography) International Multicenter Study. J Am Coll Cardiol. 2012 Jan 24;59(4):379-87. doi: 10.1016/j.jacc.2011.06.079.

  PMID: 22261160 RESULT

• Wykrzykowska JJ, Arbab-Zadeh A, Godoy G, Miller JM, Lin S, Vavere A, Paul N, Niinuma H, Hoe J, Brinker J, Khosa F, Sarwar S, Lima J, Clouse ME. Assessment of in-stent restenosis using 64-MDCT: analysis of the CORE-64 Multicenter International Trial. AJR Am J Roentgenol. 2010 Jan;194(1):85-92. doi: 10.2214/AJR.09.2652.

  PMID: 20028909 RESULT

• Takagi H, Tanaka R, Nagata K, Ninomiya R, Arakita K, Schuijf JD, Yoshioka K. Diagnostic performance of coronary CT angiography with ultra-high-resolution CT: Comparison with invasive coronary angiography. Eur J Radiol. 2018 Apr;101:30-37. doi: 10.1016/j.ejrad.2018.01.030. Epub 2018 Feb 1.

  PMID: 29571798 RESULT

• Tanaka R, Yoshioka K, Takagi H, Schuijf JD, Arakita K. Novel developments in non-invasive imaging of peripheral arterial disease with CT: experience with state-of-the-art, ultra-high-resolution CT and subtraction imaging. Clin Radiol. 2019 Jan;74(1):51-58. doi: 10.1016/j.crad.2018.03.002. Epub 2018 Apr 5.

  PMID: 29627067 RESULT

• Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. doi: 10.1161/CIRCULATIONAHA.107.688101. No abstract available.

  PMID: 17846343 RESULT

• Rochitte CE, George RT, Chen MY, Arbab-Zadeh A, Dewey M, Miller JM, Niinuma H, Yoshioka K, Kitagawa K, Nakamori S, Laham R, Vavere AL, Cerci RJ, Mehra VC, Nomura C, Kofoed KF, Jinzaki M, Kuribayashi S, de Roos A, Laule M, Tan SY, Hoe J, Paul N, Rybicki FJ, Brinker JA, Arai AE, Cox C, Clouse ME, Di Carli MF, Lima JA. Computed tomography angiography and perfusion to assess coronary artery stenosis causing perfusion defects by single photon emission computed tomography: the CORE320 study. Eur Heart J. 2014 May;35(17):1120-30. doi: 10.1093/eurheartj/eht488. Epub 2013 Nov 19.

  PMID: 24255127 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Interventions

Computed Tomography Angiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Limitations and Caveats

Study limitations include the selection of investigators at high-volume centers with skilled staff, personnel and readers, as well as the exclusion of patients with active arrhythmias.

Results Point of Contact

• Title: Armin A. Zadeh
• Organization: Johns Hopkins University

azadeh1@jh.edu

4105020549

Study Officials

• Armin A Zadeh, MD PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients are being asked to undergo a research CT scan in addition to the clinically prescribed invasive coronary angiogram (each patient is the patient's own "control" for the diagnostic test)

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: November 22, 2019
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: June 16, 2026
• Results First Posted: June 16, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BR (1); JP (1)