Computed Tomography as the First-Choice Diagnostics in High Pre-Test Probability of Coronary Artery Disease

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of computed tomography angiography in the diagnostic and therapeutic cycle as the first-choice method of imaging in the diagnosis of patients with a high probability of stable coronary artery disease according to European Society of Cardiology recommendations.

Detailed Description
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A prospective, randomized open-label, single center trial to evaluate superiority of angio-CT to a classic coronary angiography (concerning effectiveness and safety) in the diagnosis of stable coronary artery disease in patients with indications for invasive coronary angiography.

Official Title
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Coronary Artery Computed Tomography as the First-Choice Imaging Diagnostics in Patients With High Pre-Test Probability of Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Cardiac CT as the first diagnostic modality in suspected CAD
* Other: Invasive coronary angiography as indicated by the guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Patients providing written informed consent Indications for elective invasive coronary angiography defined by European Society of Cardiology as: Left ventricle ejection fraction <50% and typical angina symptoms, Probability of coronary artery disease due to criteria of age, sex and symptoms >85%, or Probability of coronary artery disease due to criteria of age, sex and symptoms 50-85% with positive or moderate cardiac stress test. Exclusion Criteria: No Consent to the study Acute coronary syndrome Recurrence of typical angina symptoms 1 year after the last percutaneous coronary revascularization, Contraindications to invasive coronary angiography GFR <60 ml/min/1.73m2 Significant arrhythmia BMI >35 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cardiac CT<br>60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo computed tomography angiography (cardiac CT) as the first-choice imaging diagnostics | Other: Cardiac CT as the first diagnostic modality in suspected CAD<br>* Performation of non-invasive cardiac CT angiogram<br>|
| Active Comparator: Invasive coronary angiography<br>60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo invasive coronary angiography | Other: Invasive coronary angiography as indicated by the guidelines<br>* Patient undergoes invasive coronary angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average number of invasive procedures (coronary angiography/PCI) in the arm: A. Angio - CT versus B. Classic diagnostics (superiority) |  | up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry). | 
| The proportion of avoidable invasive diagnostic procedures (coronary angiographies not followed by an intervention) in the arm: A. Angio-CT versus B. Classic diagnostics (superiority) |  | up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry). | 
| Composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization, hospitalization for cardiovascular reason, stroke |  | up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite outcome: number of serious adverse events during diagnosis and treatment of coronary artery disease | composite of: - death, acute coronary syndrome, urgent hospitalization for cardiovascular causes, stroke, unplanned PCI as a treatment of invasive coronary angiography complications, urgent CABG surgery as a result of PCI or coronary angiography complications, surgical treatment of local vascular complications or with blood products, hospitalization or prolongation of hospitalization due to local vascular complications, the occurrence of a pseudoaneurysm, fistula, or occlusion in the vascular access site, decrease in renal function (a fall of at least one stage of chronic kidney disease), 2-5 type bleeding defined by  Bleeding Academic Research Consortium, life threat, need for hospitalization or its prolongation, durable or substantial health damage. | up to 36 months (through study completion) | 
| Time to occurrence of composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization (including restenosis), urgent hospitalization for cardiovascular reason, stroke |  | up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry). | 
| Time to occurrence of composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization (including restenosis), urgent hospitalization for cardiovascular reason, stroke |  | up to 36 months (through study completion) | 
| Number of angioplasty procedures performed in accordance with ESC recommendations where the treatment planned on the basis of CT angiography by an interventional cardiologist is not treated ad-hoc. |  | up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry). | 
| Average number of therapeutic procedures (PCI/CABG). |  | up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry). | 
| Average time to complete diagnostic and therapeutic cycle (from the first examination of the coronary arteries to termination or disqualification from the surgical treatment). |  | up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry). | 
| Average consumption of resources (comparison of coronary artery disease diagnosis and treatment costs in accordance to National Health Service and Institute of Cardiology price lists. |  | up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry). | 
| Average number of days of hospitalization required to complete the diagnostic and therapeutic cycle. |  | up to 3 months (until the last diagnostic/therapeutic procedure; it is assumed it will be completed within 3 months of the participants study entry). |