NCT02291484

Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints.

Detailed description

Rationale: CT calcium and coronary lumen imaging allow efficient exclusion of coronary artery disease (CAD), but cannot assess the hemodynamic significance of obstructive findings. Addition of stress myocardial perfusion imaging, which assesses the functional relevance of coronary narrowing, completes the non-invasive cardiac evaluation. Hypothesis: A comprehensive cardiac CT examination will allow fast, accurate and complete evaluation of suspected CAD. Objective: evaluate the effectiveness and efficiency of comprehensive cardiac CT workup of suspected CAD. Study design: Open-labelled, randomized-controlled, clinical efficiency trial, with an intention-to-diagnose approach, between CT-guided management and the current standard of care (based on functional testing of provocable myocardial ischemia) in patients with suspected CAD. Study population: 250 patients (\>18 yrs) with stable chest complaints, a \>10% pre-test probability of CAD, and referred for evaluation of possible CAD. Intervention: Instead of the usual diagnostic approach, patients in the intervention group will undergo in sequence the following CT examinations: coronary calcium scan, coronary CT angiography and CT myocardial perfusion imaging, with completion dependent on results. Findings on CT will direct further management. Main study parameters/endpoints: Primary: Rate of negative invasive angiograms (as percentage of total population) Secondary: Diagnostic yield, chest complaints, quality of life, diagnostic and therapeutic procedures, overall costs and adverse events at 6 months.

Conditions

• Stable Angina Pectoris
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Cardiac CT scan	CT-guided management

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-11-14
• Last updated: 2016-08-04

Locations

4 sites across 1 country: Netherlands