Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)
- Conditions
- Coronary Artery DiseaseStable Angina Pectoris
- Interventions
- Device: Cardiac CT scan
- Registration Number
- NCT02291484
- Lead Sponsor
- Erasmus Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Men and women aged >18 years.
- Chest pain symptoms suspicious of coronary heart disease.
- Pre-test probability of coronary artery disease >10%
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comprehensive cardiac CT Cardiac CT scan 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)
- Primary Outcome Measures
Name Time Method Rate of negative invasive angiograms (as percentage of total population) 6 months Number of performed invasive angiograms with no CAD requiring intervention
- Secondary Outcome Measures
Name Time Method Chest pain complaints 6 months Proportion of patients experiencing symptoms of chest pain
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
Radiation exposure 6 months Cumulative radiation dose from diagnostic and therapeutic interventions
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
Trial Locations
- Locations (4)
Erasmus MC
🇳🇱Rotterdam, Netherlands
Maasstadziekenhuis
🇳🇱Rotterdam, Netherlands
Albert Schweizerzieknhuis
🇳🇱Dordrecht, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands