Stable Angina Pectoris, Coronary Artery Disease
Conditions
Keywords
Computed tomography, Coronary angiography, Coronary artery disease, Perfusion imaging, Comparative effectiveness, Randomized controlled trial, Cost-effectiveness
Brief 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.
Interventions
DEVICECardiac CT scan
CT-guided management
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged \>18 years. * Chest pain symptoms suspicious of coronary heart disease. * Pre-test probability of coronary artery disease \>10%
Exclusion criteria
* History of CAD: prior myocardial infarction or revascularization procedure * Contra-indication to radiation exposure (CT/SPECT): pregnancy * Contra-indication to iodine contrast media: renal failure, iodine allergy * Contra-indications to adenosine * Inability or unwillingness to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of negative invasive angiograms (as percentage of total population) | 6 months | Number of performed invasive angiograms with no CAD requiring intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 6 months | Questionnaire based quality of life score |
| Major adverse event rate | 6 months | Death, myocardial infarction, unstable angina, urgent revascularizations, CVA |
| Chest pain complaints | 6 months | Proportion of patients experiencing symptoms of chest pain |
| Number of diagnostic and therapeutic procedures | 6 months | Number of diagnostic and therapeutic procedures |
| Medical expenses | 6 months | All medical expenses related to the diagnosis and treatment of suspected CAD |
| Radiation exposure | 6 months | Cumulative radiation dose from diagnostic and therapeutic interventions |
Countries
Netherlands
Outcome results
None listed