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

Coronary Artery Disease Clinical Trial

— CAT-CAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02591992
• Other study ID #: 2.13/III/15
• Status: Recruiting
• Phase: N/A
• First received: October 27, 2015
• Last updated: February 17, 2016
• Start date: October 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2016
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: Piotr N Rudzinski, M.D.
• Phone: +48608499737
• Email: piotr.rudzinski[@]ikard.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Cardiac CT as the first diagnostic modality in suspected CAD
Performation of non-invasive cardiac CT angiogram
• Invasive coronary angiography as indicated by the guidelines
Patient undergoes invasive coronary angiography

Locations

Country	Name	City	State
Poland	Institute of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Yes
Other	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).	Yes
Primary	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).	No
Primary	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).	No
Primary	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).	Yes
Secondary	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)	Yes
Secondary	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).	Yes
Secondary	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)	Yes
Secondary	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).	No
Secondary	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).	Yes
Secondary	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).	No
Secondary	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).	No
Secondary	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).	No