Coronary Artery DiseaseCAT-CADNCT02591992
Computed Tomography as the First-Choice Diagnostics in High Pre-Test Probability of Coronary Artery Disease
A study testing Cardiac CT as the first diagnostic modality in suspected CAD and Invasive coronary angiography as indicated by the guidelines in people with Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac CT as the first diagnostic modality in suspected CAD and Invasive coronary angiography as indicated by the guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac CT as the first diagnostic modality in suspected CAD, Invasive coronary angiography as indicated by the guidelines
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CT as the first diagnostic modality in suspected CADOther
Performation of non-invasive cardiac CT angiogram
Invasive coronary angiography as indicated by the guidelinesOther
Patient undergoes invasive coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| Cardiac CT | Active comparator | 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 Receives: Other: Cardiac CT as the first diagnostic modality in suspected CAD |
| Invasive coronary angiography | Active comparator | 60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo invasive coronary angiography Receives: Other: Invasive coronary angiography as indicated by the guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average number of invasive procedures (coronary angiography/PCI) in the arm: A. Angio - CT versus B. Classic diagnostics (superiority)
Measured: 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)
Measured: 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
Measured: 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 outcomes (8)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2016 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariusz Kruk, Prof., Study chair, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591992
- Sponsor's protocol ID
- 2.13/III/15
- Acronym
- CAT-CAD
- Status last verified
- Feb 2016
- First submitted
- 27 Oct 2015
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30201310
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Computed Tomography as the First-Choice Imaging Diagnostics in Patients With High Pre-Test Probability of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02591992
- Acronym / sponsor ID
- CAT-CAD / 2.13/III/15
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac CT | Active comparator | Other: Cardiac CT as the first diagnostic modality in suspected CAD60 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 |
| Invasive coronary angiography | Active comparator | Other: Invasive coronary angiography as indicated by the guidelines60 patients with high pre-test probability o coronary artery disease will be randomly chosen and undergo invasive coronary angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years
- Patients providing written informed consent
- Indications for elective invasive coronary angiography defined by European Society of Cardiology as:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac CT as the first diagnostic modality in suspected CADPerformation of non-invasive cardiac CT angiogram | Other | Cardiac CT |
| Invasive coronary angiography as indicated by the guidelinesPatient undergoes invasive coronary angiography | Other | Invasive coronary angiography |
Primary outcome
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).
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).
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).
8 secondary outcomes
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).
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)
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).
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).
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 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Derived from this study: PubMed 30201310Rudzinski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariusz Kruk, Prof. study chair
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac CT as the first diagnostic modality in suspected CAD and Invasive coronary angiography as indicated by the guidelines in people with Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr N Rudziński, M.D. (+48608499737, piotr.rudzinski@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.