CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,546 target
Drug / intervention
Computed tomography angiography (cardiac CT) +1 moreprocedure
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/NCT02400229
NCT02400229N/ACompleted

Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease: Comparative Effectiveness Research of Existing Technologies) - A Pragmatic Randomised Controlled Trial of CT Versus ICA

Charite University, Berlin, Germany·interventional·Posted Mar 27, 2015·Updated Feb 12, 2025

In Brief

A clinical study evaluating Computed tomography angiography (cardiac CT) and Invasive coronary angiography (ICA) for Coronary Artery Disease. Completed, enrolled 3,546 participants across 20 sites in 15 countries.

Detailed Summary

The primary hypothesis is that computed tomography (CT) is superior to invasive coronary angiography (ICA) concerning the primary endpoint MACE (MACE = major adverse cardiovascular event; defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) after a maximum follow-up of 4 years, in other words, that CT will result in a significantly lower rate of MACE. Secondary outcomes include MICE (MICE = minor cardiovascular events), procedural complications, cost-effectiveness, radiation exposure, cross-over to CT or ICA, gender differences, and health-related quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Czechia, Denmark, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Poland, Portugal, Romania, Serbia, Spain, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 27, 2015
Enrollment StartOct 3, 2015
Primary CompletionMar 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 11.3 years ago

Interventions

Computed tomography angiography (cardiac CT)procedure

Clinical management/treatment decisions based on cardiac computed tomography including coronary calcium scoring and coronary computed tomography angiography

Invasive coronary angiography (ICA)procedure

Clinical management/treatment decisions based on invasive coronary angiography