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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Other: Invasive coronary angiography as indicated by the guidelines; Other: Cardiac CT as the first diagnostic modality in suspected CAD

• Registration Number: NCT02591992
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-18
• Primary Completion: 2016-11
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Invasive coronary angiography	Invasive coronary angiography as indicated by the guidelines	60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo invasive coronary angiography
Cardiac CT	Cardiac CT as the first diagnostic modality in suspected CAD	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
composite outcome: number of serious adverse events during diagnosis and treatment of coronary artery disease	up to 36 months (through study completion)	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.
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).

Trial Locations

Locations (1)

Institute of Cardiology; 🇵🇱 Warsaw, Poland