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

National Institute of Cardiology, Warsaw, Poland

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Other: Cardiac CT as the first diagnostic modality in suspected CAD; Other: Invasive coronary angiography as indicated by the guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT02591992

2.13/III/15

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >18 years

2. Patients providing written informed consent

3. 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

1. No Consent to the study
2. Acute coronary syndrome
3. Recurrence of typical angina symptoms 1 year after the last percutaneous coronary revascularization,
4. Contraindications to invasive coronary angiography
5. GFR <60 ml/min/1.73m2
6. Significant arrhythmia
7. BMI >35 kg/m2

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Cardiac CT

Active Comparator group

Description:

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

Treatment:

Other: Cardiac CT as the first diagnostic modality in suspected CAD

Invasive coronary angiography

Active Comparator group

Description:

60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo invasive coronary angiography

Treatment:

Other: Invasive coronary angiography as indicated by the guidelines