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

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

Interventions

DIAGNOSTIC_TEST

CT angiography

Diagnostic CT angiography

DIAGNOSTIC_TEST

Invasive coronary angiography

Diagnostic invasive coronary angiography

Sponsors & Collaborators

• Canon Medical Systems, USA

  collaborator INDUSTRY

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Armin A Zadeh, MD PhD · Johns Hopkins University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-22

Primary Completion

2025-07-31

Completion

2025-07-31

FDA Device

Yes

Countries

• United States

Study Locations