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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Cardiac CT as the first diagnostic modality in suspected CAD
Invasive coronary angiography as indicated by the guidelines
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cardiac CT

Invasive coronary angiography

Arm 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

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

Outcomes

Primary Outcome Measures

The average number of invasive procedures (coronary angiography/PCI) in the arm: A. Angio - CT versus B. Classic diagnostics (superiority)
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)
Composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization, hospitalization for cardiovascular reason, stroke

Secondary Outcome Measures

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.
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 to occurrence of composite outcome of: myocardial infarction, death, acute coronary syndrome, unplanned coronary revascularization (including restenosis), urgent hospitalization for cardiovascular reason, stroke
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.
Average number of therapeutic procedures (PCI/CABG).
Average time to complete diagnostic and therapeutic cycle (from the first examination of the coronary arteries to termination or disqualification from the surgical treatment).
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.
Average number of days of hospitalization required to complete the diagnostic and therapeutic cycle.

Full Information

First Posted
October 27, 2015
Last Updated
February 17, 2016
Sponsor
National Institute of Cardiology, Warsaw, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT02591992
Brief Title
Computed Tomography as the First-Choice Diagnostics in High Pre-Test Probability of Coronary Artery Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac CT
Arm Type
Active Comparator
Arm 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
Arm Title
Invasive coronary angiography
Arm Type
Active Comparator
Arm Description
60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo invasive coronary angiography
Intervention Type
Other
Intervention Name(s)
Cardiac CT as the first diagnostic modality in suspected CAD
Intervention Description
Performation of non-invasive cardiac CT angiogram
Intervention Type
Other
Intervention Name(s)
Invasive coronary angiography as indicated by the guidelines
Intervention Description
Patient undergoes invasive coronary angiography
Primary Outcome Measure Information:
Title
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).
Title
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).
Title
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 Measure Information:
Title
composite outcome: number of serious adverse events during diagnosis and treatment of coronary artery disease
Description
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 Frame
up to 36 months (through study completion)
Title
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).
Title
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)
Title
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).
Title
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).
Title
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).
Title
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).
Title
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).
Other Pre-specified Outcome Measures:
Title
The volume of contrast agent used for diagnosis and possible coronary intervention in the arm: A. Angio-CT versus B. Classic diagnostics (non-inferiority)
Description
safety co-primary outcome
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).
Title
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)
Description
safety co-primary outcome
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years Patients providing written informed consent 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: No Consent to the study Acute coronary syndrome Recurrence of typical angina symptoms 1 year after the last percutaneous coronary revascularization, Contraindications to invasive coronary angiography GFR <60 ml/min/1.73m2 Significant arrhythmia BMI >35 kg/m2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr N Rudziński, M.D.
Phone
+48608499737
Email
piotr.rudzinski@ikard.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Mariusz Kruk, Prof.
Phone
+48223434342
Email
mkruk@ikard.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariusz Kruk, Prof.
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
30201310
Citation
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.
Results Reference
derived

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

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