CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 175 enrolled / 175 target
Drug / intervention
CT angiography +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04272060
NCT04272060N/ACompletedOn Track (2.2/mo)Completion was 11mo ago

Ultra-High Resolution CT vs. Conventional Angiography for Detecting Hemodynamically Significant Coronary Artery Disease - The Core-PRECISION MULTI-CENTER STUDY

Johns Hopkins University·interventional·Posted Feb 17, 2020·Updated Jun 16, 2026

In Brief

A clinical study evaluating CT angiography and Invasive coronary angiography for Coronary Artery Disease. Completed, enrolled 175 participants across 3 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Japan, United States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartNov 22, 2019
Primary CompletionJul 31, 2025
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 6.4 years ago

Arms & Interventions

CT Angiographyexperimental

Research CT angiography.

Diagnostic Test: CT angiography
Conventional Angiographyactive_comparator

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

Diagnostic Test: Invasive coronary angiography

Interventions

CT angiographyother

Diagnostic CT angiography

Invasive coronary angiographyother

Diagnostic invasive coronary angiography