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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2016
• Main ID: NCT02591992
• Date of registration: 27/10/2015
• Prospective Registration: No
• Primary sponsor: Institute of Cardiology, Warsaw, Poland
• Public title: Computed Tomography as the First-Choice Diagnostics in High Pre-Test Probability of Coronary Artery Disease CAT-CAD
• Scientific title: Coronary Artery Computed Tomography as the First-Choice Imaging Diagnostics in Patients With High Pre-Test Probability of Coronary Artery Disease
• Date of first enrolment: October 2015
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02591992
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

Poland

Contacts

• Name: Piotr N Rudzinski, M.D.

• Name: Mariusz Kruk, Prof.
• Affiliation: Institute of Cardiology, Warsaw, Poland

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

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

Other: Invasive coronary angiography as indicated by the guidelines

Primary Outcome(s)

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) [Time Frame: 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 average number of invasive procedures (coronary angiography/PCI) in the arm: A. Angio - CT versus B. Classic diagnostics (superiority) [Time Frame: 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 [Time Frame: 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(s)

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. [Time Frame: 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). [Time Frame: 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).]

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. [Time Frame: 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). [Time Frame: 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 [Time Frame: up to 36 months (through study completion)]

Average number of days of hospitalization required to complete the diagnostic and therapeutic cycle. [Time Frame: 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: number of serious adverse events during diagnosis and treatment of coronary artery disease [Time Frame: 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 [Time Frame: 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 ID(s)

2.13/III/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors