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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac CT | Active Comparator | 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 |
|
| Invasive coronary angiography | Active Comparator | 60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo invasive coronary angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac CT as the first diagnostic modality in suspected CAD | Other | Performation of non-invasive cardiac CT angiogram |
|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| composite outcome: number of serious adverse events during diagnosis and treatment of coronary artery disease | composite of: - death,
|
| Measure | Description | Time Frame |
|---|---|---|
| The volume of contrast agent used for diagnosis and possible coronary intervention in the arm: A. Angio-CT versus B. Classic diagnostics (non-inferiority) | safety co-primary outcome | 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). |
Inclusion Criteria:
Age >18 years
Patients providing written informed consent
Indications for elective invasive coronary angiography defined by European Society of Cardiology as:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr N Rudziński, M.D. | Contact | +48608499737 | piotr.rudzinski@ikard.pl | |
| Mariusz Kruk, Prof. | Contact | +48223434342 | mkruk@ikard.pl |
| Name | Affiliation | Role |
|---|---|---|
| Mariusz Kruk, Prof. | National Institute of Cardiology, Warsaw, Poland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cardiology | Recruiting | Warsaw | 04-628 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30201310 | Derived | Rudzinski PN, Kruk M, Kepka C, Schoepf UJ, Duguay T, Dzielinska Z, Pregowski J, Witkowski A, Ruzyllo W, Demkow M. The value of Coronary Artery computed Tomography as the first-line anatomical test for stable patients with indications for invasive angiography due to suspected Coronary Artery Disease: CAT-CAD randomized trial. J Cardiovasc Comput Tomogr. 2018 Nov-Dec;12(6):472-479. doi: 10.1016/j.jcct.2018.08.004. Epub 2018 Sep 4. |
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| Invasive coronary angiography as indicated by the guidelines | Other | Patient undergoes invasive coronary angiography |
|
| 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). |
| The radiation dose used for diagnosis of coronary artery disease and possible intervention in the arm: A. Angio-CT versus B. Classic diagnostics (non-inferiority) |
safety co-primary outcome |
| 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). |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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