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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-628
    • Recruiting
    • Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cardiac CT; 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; Performation of non-invasive cardiac CT angiogram
Active Comparator: Invasive coronary angiography; 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; Patient undergoes invasive coronary angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Other Outcome Measures

Outcome Measure	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).
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).

Collaborators and Investigators

• Sponsor: Institute of Cardiology, Warsaw, Poland
• Investigators: Study Chair: Mariusz Kruk, Prof., Institute of Cardiology, Warsaw, Poland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Estimate): February 18, 2016
• Last Update Submitted That Met QC Criteria: February 17, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2.13/III/15