Ischemic Heart DiseaseCT-FOCINCT05218694
Coronary Computed Tomography Angiography For Optimized Invasive Coronary examInation
A study testing CCTA guided focused coronary angiography examination. in people with Ischemic Heart Disease and Coronary Artery Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
Coronary computed tomography angiography (CCTA) is a non-invasive method for visualization of the coronary arteries. The anatomical information obtained by CCTA, however, is rarely integrated into a subsequent coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease, Coronary Artery Disease
- What is being tested?
- CCTA guided focused coronary angiography examination.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2022to 28 Feb 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 81 years
- Stable angina
- at least 1 vessel disease in either the left coronary artery or right coronary artery
- Stenosis grater than 50% and no stenosis greater than 40% on contralateral vessel unless fractional flow reserve by CT (FFRct) >0.80
- Vessel segment > 2 mm in diameter
- Subject eligible for Dual Anti Platelet Therapy (DAPT
Who cannot join
- Significant bleeding risk or other contraindications against heparinization or DAPT
- Known pregnancy
- Life expectancy < 120 days
- Patient unable to provide informed consent
- Patients with CTO (Chronic Total Occlusion).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Depart. of Cardiology
Aarhus N, Central Region, 8200
About this study
Coronary computed tomography angiography (CCTA) is a non-invasive method for visualization of the coronary arteries. The anatomical information obtained by CCTA, however, is rarely integrated into a subsequent coronary intervention. The CT-FOCI trial aims to evaluate, in a randomized setting, the benefit of implementing the information obtained by CCTA as part of the invasive examination using a CT-guided algorithm (CTGA). Patients (n=120) with symptoms of stable angina pectoris will be randomized 1:1 after CCTA has determined at least 1 stenosis with luminal diameter reduction of minimum 50% in a vessel segment > 2 mm in diameter. Subsequent, invasive examination and intervention will utilize the information available according to randomization. Primary efficacy endpoints are a reduction in patient radiation exposure, procedure time, procedural utensils, and contrast use.
Secondary endpoints is significant stenosis in the non-target vessel, only available in the conventional group.
Read the detailed description
The study is a randomized, single center trial. Patients (n=120) referred for CCTA due to symptoms suggesting obstructive coronary disease (shortness of breath on exertion or angina in relation to activity), are randomized 1:1 if CCTA finds coronary lesions suggestive of obstructive coronary artery disease in at lest one vessel and thus indication for further investigation by invasive examination.
The patients are randomized to a standard treatment (ST) and a protocol with a CT-guided algorithm (CTGA) for optimal interventional work-flow. ST includes the use of two diagnostic cathers and examination of both coronary arteries by at least 6 different standard projections best optimizing the view of the coronary lesions. Additional projections may be included if deemed necessary for optimal angiographic evaluation. Procedural time consumption (timepoint 1) is measured at the completion of the angiogram as specified (7.4.2). If there is a switch to a guiding catheter and subsequent coronary physiology test (fractional flow reserve [FFR]) this is marked at timepoint 2 at the conclusion of the FFR.
In the CTGA group only the artery suspected of having obstructive coronary disease is examined. Anatomy of the vessel, optimal viewing projections and choice of catheter is determined. A guiding catheter is used as first choice based on the artery involved and the aortic anatomy. Time is recorded according to the ST group, with timepoint 1 after conclusion of the angiogram, timepoint 2 after FFR.
On the day of invasive examination, the total amount of contrast, radiation dose, procedural time consumption and cost of utensils are registered as primary endpoints. In the conventional group, any significant stenosis in the non-target vessel
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease
- Being tested
- CCTA guided focused coronary angiography examination.
- Keywords
- CCTA
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTA guided focused coronary angiography examination.Diagnostic test
Focused examination based on Images from CCTA, by choice of optimal catheter used and projection.
| Study group | Role | What they receive |
|---|---|---|
| CT-guided algorithm (CTGA) | Experimental | In the CTGA group only the artery suspected of having obstructive coronary disease is examined. Anatomy of the vessel, optimal viewing projections and choice of catheter is determined. A guiding catheter is used as first choice based on the artery involved and the aortic anatomy. Time is recorded according to the ST group, with timepoint 1 after conclusion of the angiogram, timepoint 2 after FFR. Receives: Diagnostic Test: CCTA guided focused coronary angiography examination. |
| Standard treatment (ST) | No intervention | ST includes the use of two diagnostic cathers and examination of both coronary arteries by at least 6 different standard projections best optimizing the view of the coronary lesions. Additional projections may be included if deemed necessary for optimal angiographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient radiation dose
After coronary angiography and percutaneous coronary intervention (PCI), the Dose Area Product (DAP) Gycm2 and the radiation time (MM:SS) is recorded.
Measured: Through angiography completion, an average of 4-5 minuets. Timepoint 1
Procedure time
The procedure time is defined at the time from first catheter insertion to final catheter removal. Time is recorded in MM:SS.
Measured: Through angiography completion, an average of 4-5 minuets. Timepoint 1
Contrast use
The amount of contrast medium used for examination and intervention is measured (ml) by weight measurements (gram = ml).
Measured: Through angiography completion, an average of 4-5 minuets. Timepoint 1
utensils use
The use of utensils are logged and a cost estimate subsequently calculated on the basis of the current price list (DKK/USD).
Measured: Through angiography completion, an average of 4-5 minuets. Timepoint 1
Secondary outcomes (1)
Stenosis in non-target vessel
Significant stenosis in non-target vessel, (only conventional grope), confirmed by FFR <0.80
Measured: Through angiography completion, an average of 4-5 minuets. Timepoint 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 May 2022
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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
- Model description
- Patients (n=120) are randomized 1:1
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolaj Brejnholt Støttrup, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218694
- Sponsor's protocol ID
- CT-FOCI01
- Acronym
- CT-FOCI
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2021
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Computed Tomography Angiography For Optimized Invasive Coronary examInation
- ClinicalTrials.gov ID
- NCT05218694
- Acronym / sponsor ID
- CT-FOCI / CT-FOCI01
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease
- Keywords
- CCTA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 1 Feb 2022 (actual)
- 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.
Coronary computed tomography angiography (CCTA) is a non-invasive method for visualization of the coronary arteries. The anatomical information obtained by CCTA, however, is rarely integrated into a subsequent coronary intervention. The CT-FOCI trial aims to evaluate, in a randomized setting, the benefit of implementing the information obtained by CCTA as part of the invasive examination using a CT-guided algorithm (CTGA). Patients (n=120) with symptoms of stable angina pectoris will be randomized 1:1 after CCTA has determined at least 1 stenosis with luminal diameter reduction of minimum 50% in a vessel segment > 2 mm in diameter. Subsequent, invasive examination and intervention will utilize the information available according to randomization. Primary efficacy endpoints are a reduction in patient radiation exposure, procedure time, procedural utensils, and contrast use.
Secondary endpoints is significant stenosis in the non-target vessel, only available in the conventional group.
Detailed description
The study is a randomized, single center trial. Patients (n=120) referred for CCTA due to symptoms suggesting obstructive coronary disease (shortness of breath on exertion or angina in relation to activity), are randomized 1:1 if CCTA finds coronary lesions suggestive of obstructive coronary artery disease in at lest one vessel and thus indication for further investigation by invasive examination.
The patients are randomized to a standard treatment (ST) and a protocol with a CT-guided algorithm (CTGA) for optimal interventional work-flow. ST includes the use of two diagnostic cathers and examination of both coronary arteries by at least 6 different standard projections best optimizing the view of the coronary lesions. Additional projections may be included if deemed necessary for optimal angiographic evaluation. Procedural time consumption (timepoint 1) is measured at the completion of the angiogram as specified (7.4.2). If there is a switch to a guiding catheter and subsequent coronary physiology test (fractional flow reserve [FFR]) this is marked at timepoint 2 at the conclusion of the FFR.
In the CTGA group only the artery suspected of having obstructive coronary disease is examined. Anatomy of the vessel, optimal viewing projections and choice of catheter is determined. A guiding catheter is used as first choice based on the artery involved and the aortic anatomy. Time is recorded according to the ST group, with timepoint 1 after conclusion of the angiogram, timepoint 2 after FFR.
On the day of invasive examination, the total amount of contrast, radiation dose, procedural time consumption and cost of utensils are registered as primary endpoints. In the conventional group, any significant stenosis in the non-target vessel
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients (n=120) are randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| CT-guided algorithm (CTGA) | Experimental | Diagnostic Test: CCTA guided focused coronary angiography examination.In the CTGA group only the artery suspected of having obstructive coronary disease is examined. Anatomy of the vessel, optimal viewing projections and choice of catheter is determined. A guiding catheter is used as first choice based on the artery involved and the aortic anatomy. Time is recorded according to the ST group, with timepoint 1 after conclusion of the angiogram, timepoint 2 after FFR. |
| Standard treatment (ST) | No intervention | –ST includes the use of two diagnostic cathers and examination of both coronary arteries by at least 6 different standard projections best optimizing the view of the coronary lesions. Additional projections may be included if deemed necessary for optimal angiographic evaluation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 and < 81 years
- Stable angina
- at least 1 vessel disease in either the left coronary artery or right coronary artery
- Stenosis grater than 50% and no stenosis greater than 40% on contralateral vessel unless fractional flow reserve by CT (FFRct) >0.80
- Vessel segment > 2 mm in diameter
Key exclusion criteria (5 listed)
- Significant bleeding risk or other contraindications against heparinization or DAPT
- Known pregnancy
- Life expectancy < 120 days
- Patient unable to provide informed consent
- Patients with CTO (Chronic Total Occlusion).
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 |
|---|---|---|
| CCTA guided focused coronary angiography examination.Focused examination based on Images from CCTA, by choice of optimal catheter used and projection. | Diagnostic test | CT-guided algorithm (CTGA) |
Primary outcome
Patient radiation dose
Time frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1
After coronary angiography and percutaneous coronary intervention (PCI), the Dose Area Product (DAP) Gycm2 and the radiation time (MM:SS) is recorded.
Procedure time
Time frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1
The procedure time is defined at the time from first catheter insertion to final catheter removal. Time is recorded in MM:SS.
Contrast use
Time frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1
The amount of contrast medium used for examination and intervention is measured (ml) by weight measurements (gram = ml).
utensils use
Time frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1
The use of utensils are logged and a cost estimate subsequently calculated on the basis of the current price list (DKK/USD).
1 secondary outcome
Stenosis in non-target vessel
Time frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Ischemic Heart Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCTA guided focused coronary angiography examination. in people with Ischemic Heart Disease and Coronary Artery Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 5 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: finished, as of the sponsor's last update on 26 Aug 2026. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient radiation dose (time frame: Through angiography completion, an average of 4-5 minuets. Timepoint 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.