A Phase 3 interventional study of Cardiac CT scan in Stable Angina Pectoris and Coronary Artery Disease, sponsored by Erasmus Medical Center. Completed at 4 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by Erasmus Medical Center · Phase 3, Interventional, and Diagnostic
Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 250 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tiered cardiac CT protocol: 1. CT calcium scan 2. CT angiography (if calcium scan positive or high pre-test probability) 3. CT perfusion (if \>50% stenosis on CTA, or cannot be ruled out)
Device: Cardiac CT scan
Standard diagnostic management of suspected CAD, using stress testing
CT-guided management
Rate of negative invasive angiograms (as percentage of total population)
Number of performed invasive angiograms with no CAD requiring intervention
Time frame: 6 months
Chest pain complaints
Proportion of patients experiencing symptoms of chest pain
Time frame: 6 months
Quality of life
Questionnaire based quality of life score
Time frame: 6 months
Major adverse event rate
Death, myocardial infarction, unstable angina, urgent revascularizations, CVA
Time frame: 6 months
Radiation exposure
Cumulative radiation dose from diagnostic and therapeutic interventions
Time frame: 6 months
Number of diagnostic and therapeutic procedures
Number of diagnostic and therapeutic procedures
Time frame: 6 months
Medical expenses
All medical expenses related to the diagnosis and treatment of suspected CAD
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center